Steroidal contraceptives: effect on carbohydrate metabolism in women without diabetes mellitus.

BACKGROUND: Many hormonal contraceptives have been associated with changes in carbohydrate metabolism. Alterations may include decreased glucose tolerance and increased insulin resistance, which are risk factors for Type 2 diabetes mellitus and cardiovascular disease. These issues have been raised primarily with contraceptives containing estrogen. OBJECTIVES: To evaluate the effect of hormonal contraceptives on carbohydrate metabolism in healthy women and those at risk for diabetes due to overweight. SEARCH METHODS: In April 2014, we searched the computerized databases MEDLINE, POPLINE, CENTRAL, and LILACS for studies of hormonal contraceptives and carbohydrate metabolism. We also searched for clinical trials in ClinicalTrials.gov and ICTRP. The initial search also included EMBASE. SELECTION CRITERIA: All randomized controlled trials were considered if they examined carbohydrate metabolism in women without diabetes who used hormonal contraceptives for contraception. Comparisons could be a placebo, a non-hormonal contraceptive, or another hormonal contraceptive that differed in drug, dosage, or regimen. Interventions included at least three cycles. Outcomes included glucose and insulin measures. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts identified during the literature searches. The data were extracted and entered into RevMan. We wrote to researchers for missing data. For continuous variables, the mean difference (MD) was computed with 95% confidence interval (CI) using a fixed-effect model. For dichotomous outcomes, the Peto odds ratio with 95% CI was calculated. MAIN RESULTS: We found 31 trials that met the inclusion criteria. No new trials were eligible in 2014. Twenty-one trials compared combined oral contraceptives (COCs); others examined different COC regimens, progestin-only pills, injectables, a vaginal ring, and implants. None included a placebo. Of 34 comparisons, eight had any notable difference between the study groups in an outcome. Twelve trials studied desogestrel-containing COCs, and the few differences from levonorgestrel COCs were inconsistent. A meta-analysis of two studies showed the desogestrel group had a higher mean fasting glucose (MD 0.20; 95% CI 0.00 to 0.41). Where data could not be combined, single studies showed lower mean fasting glucose (MD -0.40; 95% CI -0.72 to -0.08) and higher means for two-hour glucose response (MD 1.08; 95% CI 0.45 to 1.71) and insulin area under the curve (AUC) (MD 20.30; 95% CI 4.24 to 36.36). Three trials examined the etonogestrel vaginal ring and one examined an etonogestrel implant. One trial showed the ring group had lower mean AUC insulin than the levonorgestrel-COC group (MD -204.51; 95% CI -389.64 to -19.38). Of eight trials of norethisterone preparations, five compared COCs and three compared injectables. In a COC trial, a norethisterone group had smaller mean change in glucose two-hour response than a levonorgestrel-COC group (MD -0.30; 95% CI -0.54 to -0.06). In an injectable study, a group using depot medroxyprogesterone acetate had higher means than the group using norethisterone enanthate for fasting glucose (MD 10.05; 95% CI 3.16 to 16.94), glucose two-hour response (MD 17.00; 95% CI 5.67 to 28.33), and fasting insulin (MD 3.40; 95% CI 2.07 to 4.73). Among five recent trials, two examined newer COCs with different estrogen types. One showed the group with nomegestrel acetate plus 17ß-estradiol had lower means than the levonorgestrel group for incremental AUC glucose (MD -1.43; 95% CI -2.55 to -0.31) and glycosylated hemoglobin (HbA1c) (MD -0.10; 95% CI -0.18 to -0.02). Two trials compared extended versus conventional (cyclic) regimens. With a dienogest COC, an extended-use group had greater mean change in AUC glucose (MD 82.00; 95% CI 10.72 to 153.28). In a small trial using two levonorgestrel COCs, the lower-dose group showed smaller mean change in fasting glucose (MD -3.00; 95% CI -5.89 to -0.11), but the obese and normal weight women did not differ significantly. AUTHORS' CONCLUSIONS: Current evidence suggests no major differences in carbohydrate metabolism between different hormonal contraceptives in women without diabetes. We cannot make strong statements due to having few studies that compared the same types of contraceptives. Many trials had small numbers of participants and some had large losses. Many of the earlier studies had limited reporting of methods. We still know very little about women at risk for metabolic problems due to being overweight. More than half of the trials had weight restrictions as inclusion criteria. Only one small trial stratified the groups by body mass index (obese versus normal).

Theory-based interventions for contraception.

BACKGROUND: The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, many educational interventions addressing contraception have no explicit theoretical base. OBJECTIVES: To review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice and encourage or improve contraceptive use. SEARCH METHODS: To 1 November 2016, we searched for trials that tested a theory-based intervention for improving contraceptive use in PubMed, CENTRAL, POPLINE, Web of Science, ClinicalTrials.gov, and ICTRP. For the initial review, we wrote to investigators to find other trials. SELECTION CRITERIA: Included trials tested a theory-based intervention for improving contraceptive use. Interventions addressed the use of one or more methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy and contraceptive choice or use. DATA COLLECTION AND ANALYSIS: We assessed titles and abstracts identified during the searches. One author extracted and entered the data into Review Manager; a second author verified accuracy. We examined studies for methodological quality.For unadjusted dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). Cluster randomized trials used various methods of accounting for the clustering, such as multilevel modeling. Most reports did not provide information to calculate the effective sample size. Therefore, we presented the results as reported by the investigators. We did not conduct meta-analysis due to varied interventions and outcome measures. MAIN RESULTS: We included 10 new trials for a total of 25. Five were conducted outside the USA. Fifteen randomly assigned individuals and 10 randomized clusters. This section focuses on nine trials with high or moderate quality evidence and an intervention effect. Five based on social cognitive theory addressed preventing adolescent pregnancy and were one to two years long. The comparison was usual care or education. Adolescent mothers with a home-based curriculum had fewer second births in two years (OR 0.41, 95% CI 0.17 to 1.00). Twelve months after a school-based curriculum, the intervention group was more likely to report using an effective contraceptive method (adjusted OR 1.76 ± standard error (SE) 0.29) and using condoms during last intercourse (adjusted OR 1.68 ± SE 0.25). In alternative schools, after five months the intervention group reported more condom use during last intercourse (reported adjusted OR 2.12, 95% CI 1.24 to 3.56). After a school-based risk-reduction program, at three months the intervention group was less likely to report no condom use at last intercourse (adjusted OR 0.67, 95% CI 0.47 to 0.96). The risk avoidance group (abstinence-focused) was less likely to do so at 15 months (OR 0.61, 95% CI 0.45 to 0.85). At 24 months after a case management and peer-leadership program, the intervention group reported more consistent use of hormonal contraceptives (adjusted relative risk (RR) 1.30, 95% CI 1.06 to 1.58), condoms (RR 1.57, 95% CI 1.28 to 1.94), and dual methods (RR 1.36, 95% CI 1.01 to 1.85).Four of the nine trials used motivational interviewing (MI). In three studies, the comparison group received handouts. The MI group more often reported effective contraception use at nine months (OR 2.04, 95% CI 1.47 to 2.83). In two studies, the MI group was less likely to report using ineffective contraception at three months (OR 0.31, 95% CI 0.12 to 0.77) and four months (OR 0.56, 95% CI 0.31 to 0.98), respectively. In the fourth trial, the MI group was more likely than a group with non-standard counseling to initiate long-acting reversible contraception (LARC) by one month (OR 3.99, 95% CI 1.36 to 11.68) and to report using LARC at three months (OR 3.38, 95% CI 1.06 to 10.71). AUTHORS' CONCLUSIONS: The overall quality of evidence was moderate. Trials based on social cognitive theory focused on adolescents and provided multiple sessions. Those using motivational interviewing had a wider age range but specific populations. Sites with low resources need effective interventions adapted for their settings and their typical clients. Reports could be clearer about how the theory was used to design and implement the intervention.

Behavioral interventions for improving contraceptive use among women living with HIV.

BACKGROUND: Contraception services can help meet the family planning goals of women living with HIV as well as prevent mother-to-child transmission. Due to antiretroviral therapy, survival has improved for people living with HIV, and more HIV-positive women may desire to have a child or another child. Behavioral interventions, involving counseling or education, can help women choose and use an appropriate contraceptive method. OBJECTIVES: We systematically reviewed studies of behavioral interventions for HIV-positive women intended to inform contraceptive choice, encourage contraceptive use, or promote adherence to a contraceptive regimen. SEARCH METHODS: Until 2 August 2016, we searched MEDLINE, CENTRAL, Web of Science, POPLINE, ClinicalTrials.gov and ICTRP. For the initial review, we examined reference lists and unpublished project reports, and we contacted investigators in the field. SELECTION CRITERIA: Studies evaluated a behavioral intervention for improving contraceptive use for family planning (FP). The comparison could have been another behavioral intervention, usual care, or no intervention. We also considered studies that compared HIV-positive versus HIV-negative women. We included non-randomized studies as well as randomized controlled trials (RCTs).Primary outcomes were pregnancy and contraception use, e.g. uptake of a new method or improved use or continuation of current method. Secondary outcomes were knowledge of contraceptive effectiveness and attitude about contraception or a specific contraceptive method. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data. One entered the data into RevMan and a second verified accuracy. We evaluated RCTs according to recommended principles. For non-randomized studies, we examined the quality of evidence using the Newcastle-Ottawa Quality Assessment Scale. Given the need to control for confounding factors in non-randomized studies, we used adjusted estimates from the models when available. Where we did not have adjusted analyses, we calculated the odds ratio (OR) with 95% confidence interval (CI). Due to varied study designs and interventions, we did not conduct meta-analysis. MAIN RESULTS: With three new reports, 10 studies from seven African countries met our eligibility criteria. Eight non-randomized studies included 8980 participants. Two cluster RCTs had 7136 participants across 36 sites. Three studies compared a special FP intervention versus usual care, three examined FP services integrated with HIV services, and four compared outcomes for HIV-positive and HIV-negative women.In four studies with high or moderate quality evidence, the special intervention was associated with contraceptive use or pregnancy. A study from Nigeria compared enhanced versus basic FP services. All sites had integrated FP and HIV services. Women with enhanced services were more likely to use a modern contraceptive method versus women with basic services (OR 2.48, 95% CI 1.31 to 4.72). A cluster RCT conducted in Kenya compared integrated FP and HIV services versus standard referral to a separate FP clinic. Women with integrated services were more likely to use more effective contraception (adjusted OR 1.81, 95% CI 1.24 to 2.63). Another cluster RCT compared an HIV prevention and FP intervention versus usual care in Kenya, Namibia, and Tanzania. Women at the special intervention sites in Tanzania were more likely to use highly effective contraception (adjusted OR 2.25, 95% CI 1.24 to 4.10). They were less likely to report unprotected sex (no condom use) at last intercourse (adjusted OR 0.23, 95% CI 0.14 to 0.40). Across the three countries, women at the special intervention sites were less likely to report any unprotected sex in the past two weeks (adjusted OR 0.56, 95% CI 0.32 to 0.99). A study in Côte d'Ivoire integrated HIV and FP services. HIV-positive women had a lower incidence of undesired pregnancy, but not overall pregnancy, compared with HIV-negative women (1.07 versus 2.38; reported P = 0.023). AUTHORS' CONCLUSIONS: The studies since 2009 focused on using modern or more effective methods of contraception. In those later reports, training on FP methods and counseling was more common, which may strengthen the intervention and improve the ability to meet clients' needs. The quality of evidence was moderate from the more recent studies and low for those from the 1990s.Comparative research involving contraceptive counseling for HIV-positive women is limited. The FP field needs better ways to help women choose an appropriate contraceptive and continue using that method. Improved counseling methods are especially needed for limited resource settings, such as clinics focusing on people living with HIV.

Hormonal contraceptives for contraception in overweight or obese women.

BACKGROUND: Obesity has reached epidemic proportions around the world. Effectiveness of hormonal contraceptives may be related to metabolic changes in obesity or to greater body mass or body fat. Hormonal contraceptives include oral contraceptives (OCs), injectables, implants, hormonal intrauterine contraception (IUC), the transdermal patch, and the vaginal ring. Given the prevalence of overweight and obesity, the public health impact of any effect on contraceptive efficacy could be substantial. OBJECTIVES: To examine the effectiveness of hormonal contraceptives in preventing pregnancy among women who are overweight or obese versus women with a lower body mass index (BMI) or weight. SEARCH METHODS: Until 4 August 2016, we searched for studies in PubMed (MEDLINE), CENTRAL, POPLINE, Web of Science, ClinicalTrials.gov, and ICTRP. We examined reference lists of pertinent articles to identify other studies. For the initial review, we wrote to investigators to find additional published or unpublished studies. SELECTION CRITERIA: All study designs were eligible. The study could have examined any type of hormonal contraceptive. Reports had to contain information on the specific contraceptive methods used. The primary outcome was pregnancy. Overweight or obese women must have been identified by an analysis cutoff for weight or BMI (kg/m(2)). DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data. One entered the data into RevMan and a second verified accuracy. The main comparisons were between overweight or obese women and women of lower weight or BMI. We examined the quality of evidence using the Newcastle-Ottawa Quality Assessment Scale. Where available, we included life-table rates. We also used unadjusted pregnancy rates, relative risk (RR), or rate ratio when those were the only results provided. For dichotomous variables, we computed an odds ratio with 95% confidence interval (CI). MAIN RESULTS: With 8 studies added in this update, 17 met our inclusion criteria and had a total of 63,813 women. We focus here on 12 studies that provided high, moderate, or low quality evidence. Most did not show a higher pregnancy risk among overweight or obese women. Of five COC studies, two found BMI to be associated with pregnancy but in different directions. With an OC containing norethindrone acetate and ethinyl estradiol (EE), pregnancy risk was higher for overweight women, i.e. with BMI ≥ 25 versus those with BMI < 25 (reported relative risk 2.49, 95% CI 1.01 to 6.13). In contrast, a trial using an OC with levonorgestrel and EE reported a Pearl Index of 0 for obese women (BMI ≥ 30) versus 5.59 for nonobese women (BMI < 30). The same trial tested a transdermal patch containing levonorgestrel and EE. Within the patch group, obese women in the "treatment-compliant" subgroup had a higher reported Pearl Index than nonobese women (4.63 versus 2.15). Of five implant studies, two that examined the six-capsule levonorgestrel implant showed differences in pregnancy by weight. One study showed higher weight was associated with higher pregnancy rate in years 6 and 7 combined (reported P < 0.05). In the other, pregnancy rates differed in year 5 among the lower weight groups only (reported P < 0.01) and did not involve women weighing 70 kg or more.Analysis of data from other contraceptive methods indicated no association of pregnancy with overweight or obesity. These included depot medroxyprogesterone acetate (subcutaneous), levonorgestrel IUC, the two-rod levonorgestrel implant, and the etonogestrel implant. AUTHORS' CONCLUSIONS: The evidence generally did not indicate an association between higher BMI or weight and effectiveness of hormonal contraceptives. However, we found few studies for most contraceptive methods. Studies using BMI, rather than weight alone, can provide information about whether body composition is related to contraceptive effectiveness. The contraceptive methods examined here are among the most effective when used according to the recommended regimen.We considered the overall quality of evidence to be low for the objectives of this review. More recent reports provided evidence of varying quality, while the quality was generally low for older studies. For many trials the quality would be higher for their original purpose rather than the non-randomized comparisons here. Investigators should consider adjusting for potential confounding related to BMI or contraceptive effectiveness. Newer studies included a greater proportion of overweight or obese women, which helps in examining effectiveness and side effects of hormonal contraceptives within those groups.

Progestin-only contraceptives: effects on weight.

BACKGROUND: Progestin-only contraceptives (POCs) are appropriate for many women who cannot or should not take estrogen. POCs include injectables, intrauterine contraception, implants, and oral contraceptives. Many POCs are long-acting, cost-effective methods of preventing pregnancy. However, concern about weight gain can deter the initiation of contraceptives and cause early discontinuation among users. OBJECTIVES: The primary objective was to evaluate the association between progestin-only contraceptive use and changes in body weight. SEARCH METHODS: Until 4 August 2016, we searched MEDLINE, CENTRAL, POPLINE, LILACS, ClinicalTrials.gov, and ICTRP. For the initial review, we contacted investigators to identify other trials. SELECTION CRITERIA: We considered comparative studies that examined a POC versus another contraceptive method or no contraceptive. The primary outcome was mean change in body weight or mean change in body composition. We also considered the dichotomous outcome of loss or gain of a specified amount of weight. DATA COLLECTION AND ANALYSIS: Two authors extracted the data. Non-randomized studies (NRS) need to control for confounding factors. We used adjusted measures for the primary effects in NRS or the results of matched analysis from paired samples. If the report did not provide adjusted measures for the primary analysis, we used unadjusted outcomes. For RCTs and NRS without adjusted measures, we computed the mean difference (MD) with 95% confidence interval (CI) for continuous variables. For dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% CI. MAIN RESULTS: We found 22 eligible studies that included a total of 11,450 women. With 6 NRS added to this update, the review includes 17 NRS and 5 RCTs. By contraceptive method, the review has 16 studies of depot medroxyprogesterone acetate (DMPA), 4 of levonorgestrel-releasing intrauterine contraception (LNG-IUC), 5 for implants, and 2 for progestin-only pills.Comparison groups did not differ significantly for weight change or other body composition measure in 15 studies. Five studies with moderate or low quality evidence showed differences between study arms. Two studies of a six-rod implant also indicated some differences, but the evidence was low quality.Three studies showed differences for DMPA users compared with women not using a hormonal method. In a retrospective study, weight gain (kg) was greater for DMPA versus copper (Cu) IUC in years one (MD 2.28, 95% CI 1.79 to 2.77), two (MD 2.71, 95% CI 2.12 to 3.30), and three (MD 3.17, 95% CI 2.51 to 3.83). A prospective study showed adolescents using DMPA had a greater increase in body fat (%) compared with a group not using a hormonal method (MD 11.00, 95% CI 2.64 to 19.36). The DMPA group also had a greater decrease in lean body mass (%) (MD -4.00, 95% CI -6.93 to -1.07). A more recent retrospective study reported greater mean increases with use of DMPA versus Cu IUC for weight (kg) at years 1 (1.3 vs 0.2), 4 (3.5 vs 1.9), and 10 (6.6 vs 4.9).Two studies reported a greater mean increase in body fat mass (%) for POC users versus women not using a hormonal method. The method was LNG-IUC in two studies (reported means 2.5 versus -1.3; P = 0.029); (MD 1.60, 95% CI 0.45 to 2.75). One also studied a desogestrel-containing pill (MD 3.30, 95% CI 2.08 to 4.52). Both studies showed a greater decrease in lean body mass among POC users. AUTHORS' CONCLUSIONS: We considered the overall quality of evidence to be low; more than half of the studies had low quality evidence. The main reasons for downgrading were lack of randomizations (NRS) and high loss to follow-up or early discontinuation.These 22 studies showed limited evidence of change in weight or body composition with use of POCs. Mean weight gain at 6 or 12 months was less than 2 kg (4.4 lb) for most studies. Those with multiyear data showed mean weight change was approximately twice as much at two to four years than at one year, but generally the study groups did not differ significantly. Appropriate counseling about typical weight gain may help reduce discontinuation of contraceptives due to perceptions of weight gain.

School-based interventions for improving contraceptive use in adolescents.

BACKGROUND: Young women, especially adolescents, often lack access to modern contraception. Reasons vary by geography and regional politics and culture. The projected 2015 birth rate in 'developing' regions was 56 per 1000 compared with 17 per 1000 for 'developed' regions. OBJECTIVES: To identify school-based interventions that improved contraceptive use among adolescents SEARCH METHODS: Until 6 June 2016, we searched for eligible trials in PubMed, CENTRAL, ERIC, Web of Science, POPLINE, ClinicalTrials.gov and ICTRP. SELECTION CRITERIA: We considered randomized controlled trials (RCTs) that assigned individuals or clusters. The majority of participants must have been 19 years old or younger.The educational strategy must have occurred primarily in a middle school or high school. The intervention had to emphasize one or more effective methods of contraception. Our primary outcomes were pregnancy and contraceptive use. DATA COLLECTION AND ANALYSIS: We assessed titles and abstracts identified during the searches. One author extracted and entered the data into RevMan; a second author verified accuracy. We examined studies for methodological quality.For unadjusted dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). For cluster randomized trials, we used adjusted measures, e.g. OR, risk ratio, or difference in proportions. For continuous outcomes, we used the adjusted mean difference (MD) or other measures from the models. We did not conduct meta-analysis due to varied interventions and outcome measures. MAIN RESULTS: The 11 trials included 10 cluster RCTs and an individually randomized trial. The cluster RCTs had sample sizes from 816 to 10,954; the median number of clusters was 24. Most trials were conducted in the USA and UK; one was from Mexico and one from South Africa.We focus here on the trials with moderate quality evidence and an intervention effect. Three addressed preventing pregnancy and HIV/STI through interactive sessions. One trial provided a multifaceted two-year program. Immediately after year one and 12 months after year two, the intervention group was more likely than the standard-curriculum group to report using effective contraception during last sex (reported adjusted ORs 1.62 ± standard error (SE) 0.22) and 1.76 ± SE 0.29), condom use during last sex (reported adjusted ORs 1.91 ± SE 0.27 and 1.68 ± SE 0.25), and less frequent sex without a condom in the past three months (reported ratios of adjusted means 0.50 ± SE 0.31 and 0.63 ± SE 0.23). Another trial compared multifaceted two-year programs on sexual risk reduction and risk avoidance (abstinence-focused) versus usual health education. At 3 months, the risk reduction group was less likely than the usual-education group to report no condom use at last intercourse (reported adjusted OR 0.67, 95% CI 0.47 to 0.96) and sex without a condom in the last three months (reported adjusted OR 0.59, 95% CI 0.36 to 0.95). At 3 and after 15 months, the risk avoidance group was also less likely than the usual-education group to report no condom use at last intercourse (reported adjusted ORs 0.70, 95% CI 0.52 to 0.93; and 0.61, 95% CI 0.45 to 0.85). At the same time points, the risk reduction group had a higher score than the usual-education group for condom knowledge. The third trial provided a peer-led program with eight interactive sessions. At 17 months, the intervention group was less likely than the teacher-led group to report oral contraceptive use during last sex (OR 0.57, 95% CI 0.36 to 0.91). This difference may not have been significant if the investigators had adjusted for the clustering. At 5 and 17 months, the peer-led group had a greater mean increase in knowledge of HIV and pregnancy prevention compared with the control group. An additional trial showed an effect on knowledge only. The group with an emergency contraception (EC) session was more likely than the group without the EC unit to know the time limits for using hormonal EC (pill) and the non-hormonal IUD as EC. AUTHORS' CONCLUSIONS: Since most trials addressed preventing STI/HIV and pregnancy, they emphasized condom use. However, several studies covered a range of contraceptive methods. The overall quality of evidence was low. Main reasons for downgrading the evidence were having limited information on intervention fidelity, analyzing a subsample rather than all those randomized, and having high losses.

Brief educational strategies for improving contraception use in young people.

BACKGROUND: Global high rates of unplanned pregnancy and abortion among young women demonstrate the need for increased access to modern contraceptive services. In sub-Saharan Africa, the birth rate for those aged 15 to 19 years is 121 per 1000. In the USA, 6% of teens aged 15 to 19 years became pregnant in 2010. Most pregnancies among young women to age 25 are unintended. OBJECTIVES: The aim was to identify brief educational interventions for improving contraceptive use among young people that are feasible for implementing in a clinic or similar setting with limited resources. SEARCH METHODS: To 7 March 2016, we searched for studies in CENTRAL, PubMed, POPLINE, Web of Science, ClinicalTrials.gov and ICTRP. SELECTION CRITERIA: We considered randomized controlled trials (RCTs) that assigned individuals or clusters as well as non-randomized studies (NRS). We included young people to age 25.The intervention had to be sufficiently brief for a clinic, i.e. one to three sessions of 15 to 60 minutes plus potential follow-up. The strategy had to emphasize one or more effective methods of contraception. Primary outcomes were pregnancy and contraceptive use. DATA COLLECTION AND ANALYSIS: We assessed titles and abstracts identified during the searches. One author extracted and entered the data into Review Manager; a second author verified accuracy. We examined studies for methodological quality.For dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). For continuous variables, we computed the mean difference (MD) with 95% CI. We used adjusted measures for cluster RCTs, typically ORs, that the investigators reported. For NRS, which need to control for confounding, we also used reported adjusted measures. We did not conduct meta-analysis due to varied interventions and outcome measures. MAIN RESULTS: We found 11 studies, published from 1983 to 2015, that included a total of 8338 participants. Ten were from the USA and one was from China. We focused here on intervention effects for our primary outcomes. Five studies showed some effect on contraceptive use. Of three RCTs that examined innovative counseling, one showed an intervention effect. At one year, adolescents with developmental counseling were more likely to use contraception effectively than those with standard counseling (OR 48.38, 95% CI 5.96 to 392.63).Three studies used an audiovisual tool plus counseling; two reported some effect on contraceptive use. An NRS with young men, aged 15 to 18, examined a slide-tape presentation plus reproductive health consultation. At one year, the intervention group was more likely than the standard-care group to report using an effective contraceptive and having a partner who used oral contraceptives (OCs), both at last intercourse (reported adjusted OR 1.51 and 1.66, respectively). Another study utilized a computer program for contraceptive decision-making plus standard counseling for women to age 20. At one year, fewer women in the intervention group at one site had not used OCs compared with the counseling-only group (3.4% versus 8.8%; reported P = 0.05).Three RCTs provided phone follow-up after counseling, one of which showed an effect on contraceptive use among women age 16 to 24. Women who received counseling plus phone calls to encourage contraceptive use were more likely than the counseling-only group to report consistent OC use at three months (OR 1.41, 95% CI 1.06 to 1.87) and six months (OR 1.39, 95% CI 1.03 to 1.87). Also at three months, they were more likely to report condom use at last sex (OR 1.45, 95% CI 1.03 to 2.03).Two cluster randomized trials trained providers on contraceptive methods and counseling. One trial with an intervention effect tested comprehensive contraceptive services for women to age 25, postabortion. At six months, the comprehensive-service group was more likely than the standard-care group to use an effective contraceptive (reported adjusted OR 2.03, 95% CI 1.04 to 3.98) and to use condoms consistently and correctly (reported adjusted OR 5.68, 95% CI 3.39 to 9.53). AUTHORS' CONCLUSIONS: Few studies tested brief strategies for young people. We noted heterogeneity across studies in participants' ages and life situations. Of five studies with some effect, one provided moderate-quality evidence; four were older studies with low-quality evidence. More intensive strategies could be more effective, but would also be challenging for many clinics to implement.

Hormonal and intrauterine methods for contraception for women aged 25 years and younger.

BACKGROUND: Women between the ages of 15 and 24 years have high rates of unintended pregnancy; over half of women in this age group want to avoid pregnancy. However, women under age 25 years have higher typical contraceptive failure rates within the first 12 months of use than older women. High discontinuation rates may also be a problem in this population. Concern that adolescents and young women will not find hormonal or intrauterine contraceptives acceptable or effective might deter healthcare providers from recommending these contraceptive methods. OBJECTIVES: To compare the contraceptive failure (pregnancy) rates and to examine the continuation rates for hormonal and intrauterine contraception among young women aged 25 years and younger. SEARCH METHODS: We searched until 4 August 2015 for randomized controlled trials (RCTs) that compared hormonal or intrauterine methods of contraception in women aged 25 years and younger. Computerized databases included the Cochrane Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, CINAHL, and LILACS. We also searched for current trials via ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP). SELECTION CRITERIA: We considered RCTs in any language that reported the contraceptive failure rates for hormonal or intrauterine contraceptive methods, when compared with another contraceptive method, for women aged 25 years and younger. The other contraceptive method could have been another intrauterine contraceptive, another hormonal contraceptive or different dose of the same method, or a non-hormonal contraceptive. Treatment duration must have been at least three months. Eligible trials had to include the primary outcome of contraceptive failure rate (pregnancy). The secondary outcome was contraceptive continuation rate. DATA COLLECTION AND ANALYSIS: One author conducted the primary data extraction and entered the information into Review Manager. Another author performed an independent data extraction and verified the initial entry. For dichotomous outcomes, we computed the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). Because of disparate interventions and outcome measures, we did not conduct meta-analysis. MAIN RESULTS: Five trials met the inclusion criteria. The studies included a total of 1503 women, with a mean of 301 participants. The trials compared the following contraceptives: combined oral contraceptive (COC) versus transdermal contraceptive patch, vaginal contraceptive ring, or levonorgestrel intrauterine system 20 µg/day (LNG-IUS 20); LNG-IUS 12 µg/day (LNG-IUS 12) versus LNG-IUS 16 µg/day (LNG-IUS 16); and LNG-IUS 20 versus the copper T380A intrauterine device (IUD). In the trials comparing two different types of methods, the study arms did not differ significantly for contraceptive efficacy or continuation. The sample sizes were small for two of those studies. The only significant outcome was that a COC group had a higher proportion of women who discontinued for 'other personal reasons' compared with the group assigned to the LNG-IUS 20 (OR 0.27, 95% CI 0.09 to 0.85), which may have little clinic relevance. The trial comparing LNG-IUS 12 versus LNG-IUS 16 showed similar efficacy over one and three years. In three trials that examined different LNG-IUS, continuation was at least 75% at 6 to 36 months. AUTHORS' CONCLUSIONS: We considered the overall quality of evidence to be moderate to low. Limitations were due to trial design or limited reporting. Different doses in the LNG-IUS did not appear to influence efficacy over three years. In another study, continuation of the LNG-IUS appeared at least as high as that for the COC. The current evidence was insufficient to compare efficacy and continuation rates for hormonal and intrauterine contraceptive methods in women aged 25 years and younger.

Steroidal contraceptives and bone fractures in women: evidence from observational studies.

BACKGROUND: Age-related decline in bone mass increases the risk of skeletal fractures, especially those of the hip, spine, and wrist. Steroidal contraceptives have been associated with changes in bone mineral density in women. Whether such changes affect the risk of fractures later in life is unclear. Hormonal contraceptives are among the most effective and most widely-used contraceptives. Concern about fractures may limit the use of these effective contraceptives. Observational studies can collect data on premenopausal contraceptive use as well as fracture incidence later in life. OBJECTIVES: We systematically reviewed the evidence from observational studies of hormonal contraceptive use for contraception and the risk of fracture in women. SEARCH METHODS: Through June 2015, we searched for observational studies. The databases included PubMed, POPLINE, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, EMBASE, CINAHL, and Web of Science. We also searched for recent clinical trials through ClinicalTrials.gov and the ICTRP. For other studies, we examined reference lists of relevant articles and wrote to investigators for additional reports. SELECTION CRITERIA: We included cohort and case-control studies of hormonal contraceptive use. Interventions included comparisons of a hormonal contraceptive with a non-hormonal contraceptive, no contraceptive, or another hormonal contraceptive. The primary outcome was the risk of fracture. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data. One author entered the data into RevMan, and a second author verified accuracy. We examined the quality of evidence using the Newcastle-Ottawa Quality Assessment Scale (NOS), developed for case-control and cohort studies. Sensitivity analysis included studies of moderate or high quality based on our assessment with the NOS.Given the need to control for confounding factors in observational studies, we used adjusted estimates from the models as reported by the authors. Where we did not have adjusted analyses, we calculated the odds ratio (OR) with 95% confidence interval (CI). Due to varied study designs, we did not conduct meta-analysis. MAIN RESULTS: We included 14 studies (7 case-control and 7 cohort studies). These examined oral contraceptives (OCs), depot medroxyprogesterone acetate (DMPA), and the hormonal intrauterine device (IUD). This section focuses on the sensitivity analysis with six studies that provided moderate or high quality evidence.All six studies examined oral contraceptive use. We noted few associations with fracture risk. One cohort study reported OC ever-users had increased risk for all fractures (RR 1.20, 95% CI 1.08 to 1.34). However, a case-control study with later data from a subset reported no association except for those with 10 years or more since use (OR 1.55, 95% CI 1.03 to 2.33). Another case-control study reported increased risk only for those who had 10 or more prescriptions (OR 1.09, 95% CI 1.03 to 1.16). A cohort study of postmenopausal women found no increased fracture risk for OC use after excluding women with prior fracture. Two other studies found little evidence of association between OC use and fracture risk. A cohort study noted increased risk for subgroups, such as those with longer use or specific intervals since use. A case-control study reported increased risk for any fracture only among young women with less than average use.Two case-control studies also examined progestin-only contraceptives. One reported increased fracture risk for DMPA ever-use (OR 1.44, 95% CI 1.01 to 2.06), more than four years of use (OR 2.16, 95% CI 1.32 to 3.53), and women over 50 years old. The other reported increased risk for any past use, including one or two prescriptions (OR 1.17, 95% CI 1.07 to 1.29) and for current use of 3 to 9 prescriptions (OR 1.36, 95% CI 1.15 to 1.60) or 10 or more (OR 1.54, 95% CI 1.33 to 1.78). For the levonorgestrel-releasing IUD, one study reported reduced fracture risk for ever-use (OR 0.75, 95% CI 0.64 to 0.87) and for longer use. AUTHORS' CONCLUSIONS: Observational studies do not indicate an overall association between oral contraceptive use and fracture risk. Some reported increased risk for specific user subgroups. DMPA users may have an increased fracture risk. One study indicated hormonal IUD use may be associated with decreased risk. Observational studies need adjusted analysis because the comparison groups usually differ. Investigators should be clear about the variables examined in multivariate analysis.

Education for contraceptive use by women after childbirth.

BACKGROUND: Contraceptive education is generally a standard component of postpartum care, although the effectiveness is seldom examined. The assumptions that form the basis of such programs include postpartum women being motivated to use contraception and that they will not return to a health provider for family planning advice. Women may wish to discuss contraception both prenatally and after hospital discharge. Nonetheless, two-thirds of postpartum women have unmet needs for contraception. In the USA, many adolescents have repeat pregnancies within a year of giving birth. OBJECTIVES: Assess the effectiveness of educational interventions for postpartum women on contraceptive use SEARCH METHODS: We searched for trials through June 2015 in PubMed, CENTRAL, CINAHL, POPLINE, and Web of Science. For current trials, we searched ClinicalTrials.gov and ICTRP. Previous searches also included EMBASE and PsycInfo. We also examined reference lists of relevant articles. For earlier versions, we contacted investigators to locate additional reports. SELECTION CRITERIA: We considered randomized controlled trials (RCTs) that examined postpartum education about contraceptive use, whether delivered to individuals or to groups of women. Studies that randomized clusters rather than individuals were eligible if the investigators accounted for the clustering in the analysis. The intervention must have started within one month after delivery. DATA COLLECTION AND ANALYSIS: We assessed titles and abstracts identified during the literature searches. The data were abstracted and entered into Review Manager. Studies were examined for methodological quality. For dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI) was calculated. Where data were sFor continuous variables, we computed the mean difference (MD) with 95% CI. Due to varied interventions and outcome measures, we did not conduct meta-analysis. MAIN RESULTS: Twelve trials met our eligibility criteria, included the three added in this update. The studies included a total of 4145 women. Eight trials were conducted in the USA; the others were from Australia, Nepal, Pakistan, and Syria. Four studies provided one session before hospital discharge; three had structured counseling of varying intensity and one involved informal counseling. Of eight interventions with than one contact, five focused on adolescents. Three of the five involved home visiting, one provided multiple clinic services, and one had in-person contact and phone follow-up. Of the remaining three for women of varying ages, two involved home visits and one provided phone follow-up.Our sensitivity analysis included six trials with evidence of moderate or high quality. In a study with adolescents, the group with home-based mentoring had fewer second births within two years compared to the control group (OR 0.41, 95% CI 0.17 to 1.00). The other five interventions had no effect. Of trials with lower quality evidence, two showed some effectiveness. In Nepal, women with an educational session immediately postpartum were more likely to use contraception at six months than those with a later or no session (OR 1.62, 95% CI 1.06 to 2.50). In an Australian study, teenagers in a structured home-visiting program were more likely to have effective contraception use at six months than those with standard home visits (OR 3.24; 95% CI 1.35 to 7.79). AUTHORS' CONCLUSIONS: We focused our results summary on trials with moderate or high quality evidence. Overall, the overall quality of evidence in this review was moderate to low and the evidence of effectiveness was mostly low quality. The interventions could be improved by strengthening the program design and implementation. Some studies did not report program training for providers, adherence to the intervention protocol, or measurement of participants' knowledge and skills. Many trials did not have an objective outcome measure, i.e., pregnancy test or structured questionnaire for contraceptive use. Valid and reliable outcome measures are needed to obtain meaningful results. Still, given the associated costs and logistics, some programs would not be feasible in many settings.

Interventions for pain with intrauterine device insertion.

BACKGROUND: Fear of pain during insertion of intrauterine contraception (IUC) is a barrier to use of this method. IUC includes copper-containing intrauterine devices and levonorgestrel-releasing intrauterine systems. Interventions for pain control during IUC insertion include non-steroidal anti-inflammatory drugs (NSAIDs), local cervical anesthetics, and cervical ripening agents such as misoprostol. OBJECTIVES: To review randomized controlled trials (RCTs) of interventions for reducing IUC insertion-related pain SEARCH METHODS: We searched for trials in CENTRAL, MEDLINE, EMBASE, POPLINE, ClinicalTrials.gov, and ICTRP. The most recent search was 22 June 2015. We examined reference lists of pertinent articles. For the initial review, we wrote to investigators to find other published or unpublished trials. SELECTION CRITERIA: We included RCTs that evaluated an intervention for preventing IUC insertion-related pain. The comparison could have been a placebo, no intervention, or another active intervention. The primary outcomes were self-reported pain at tenaculum placement, during IUC insertion, and after IUC insertion (up to six hours). DATA COLLECTION AND ANALYSIS: Two authors extracted data from eligible trials. For dichotomous variables, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). For continuous variables, we computed the mean difference (MD) with 95% CI. In meta-analysis of trials with different measurement scales, we used the standardized mean difference (SMD). MAIN RESULTS: We included 33 trials with 5710 participants total; 29 were published from 2010 to 2015. Studies examined lidocaine, misoprostol, NSAIDs, and other interventions. Here we synthesize results from trials with sufficient outcome data and moderate- or high-quality evidence.For lidocaine, meta-analysis showed topical 2% gel had no effect on pain at tenaculum placement (two trials) or on pain during IUC insertion (three trials). Other formulations were effective compared with placebo in individual trials. Mean score for IUC-insertion pain was lower with lidocaine and prilocaine cream (MD -1.96, 95% CI -3.00 to -0.92). Among nulliparous women, topical 4% formulation showed lower scores for IUC-insertion pain assessed within 10 minutes (MD -15.90, 95% CI -22.77 to -9.03) and at 30 minutes later (MD -11.10, 95% CI -19.05 to -3.15). Among parous women, IUC-insertion pain was lower with 10% spray (median 1.00 versus 3.00). Compared with no intervention, pain at tenaculum placement was lower with 1% paracervical block (median 12 versus 28).For misoprostol, meta-analysis showed a higher mean score for IUC insertion compared with placebo (SMD 0.27, 95% CI 0.07 to 0.46; four studies). In meta-analysis, cramping was more likely with misoprostol (OR 2.64, 95% CI 1.46 to 4.76; four studies). A trial with nulliparous women found a higher score for IUC-insertion pain with misoprostol (median 46 versus 34). Pain before leaving the clinic was higher for misoprostol in two trials with nulliparous women (MD 7.60, 95% CI 6.48 to 8.72; medians 35.5 versus 20.5). In one trial with nulliparous women, moderate or severe pain at IUC insertion was less likely with misoprostol (OR 0.30, 95% CI 0.16 to 0.55). In the same trial, the misoprostol group was more likely to rate the experience favorably. Within two trials of misoprostol plus diclofenac, shivering, headache, or abdominal pain were more likely with misoprostol. Participants had no vaginal delivery. One trial showed the misoprostol group less likely to choose or recommend the treatment.Among multiparous women, mean score for IUC-insertion pain was lower for tramadol 50 mg versus naproxen 550 mg (MD -0.63, 95% CI -0.94 to -0.32) and for naproxen versus placebo (MD -1.94, 95% CI -2.35 to -1.53). The naproxen group was less likely than the placebo group to report the insertion experience as unpleasant and not want the medication in the future. An older trial showed repeated doses of naproxen 300 mg led to lower pain scores at one hour (MD -1.04, 95% CI -1.67 to -0.41) and two hours (MD -0.98, 95% CI -1.64 to -0.32) after insertion. Most women were nulliparous and also had lidocaine paracervical block. AUTHORS' CONCLUSIONS: Nearly all trials used modern IUC. Most effectiveness evidence was of moderate quality, having come from single trials. Lidocaine 2% gel, misoprostol, and most NSAIDs did not help reduce pain. Some lidocaine formulations, tramadol, and naproxen had some effect on reducing IUC insertion-related pain in specific groups. The ineffective interventions do not need further research.

Immediate postpartum insertion of intrauterine device for contraception.

BACKGROUND: Women who want to start intrauterine contraception (IUC) during the postpartum period might benefit from IUC insertion immediately after delivery. Postplacental insertion greatly reduces the risk of subsequent pregnancy and eliminates the need for a return visit to start contraception. Without the option of immediate insertion, many women may never return for services or may adopt less effective contraception. OBJECTIVES: Our aim was to examine the outcomes of IUC insertion immediately after placenta delivery (within 10 minutes), especially when compared with insertion at other postpartum times. We focused on successful IUC placement (insertion), subsequent expulsion, and method use. SEARCH METHODS: We searched for trials until 1 April 2015. Sources included PubMed (MEDLINE), the Cochrane Central Register of Controlled Trials (CENTRAL), POPLINE, Web of Science, EMBASE, LILACS, ClinicalTrials.gov, and ICTRP. For the original review, the authors contacted investigators to identify other trials. SELECTION CRITERIA: We sought randomized controlled trials (RCTs) with at least one treatment arm that involved immediate IUC placement (i.e., within 10 minutes of placenta delivery). Comparison arms could have included early postpartum insertion (from 10 minutes postplacental to hospital discharge) or standard insertion (during a postpartum visit). Trials could also have compared different IUC methods or insertion techniques. Delivery may have been vaginal or cesarean. Primary outcomes were placement (insertion), subsequent expulsion, and method use at study assessment. DATA COLLECTION AND ANALYSIS: For dichotomous outcomes, we used the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). Earlier studies primarily reported results as life-table rates. We aggregated trials in a meta-analysis if they had similar interventions and outcome measures. A sensitivity analysis included studies with moderate or high quality evidence and sufficient outcome data. MAIN RESULTS: We included 15 trials. Seven studies reported from 2010 to 2014 were added to eight from the original 2001 review. Newer trials compared immediate postplacental insertion versus early (10 minutes to 48 hours) or standard insertion (during the postpartum visit). Of four with full reports, three were small trials. The other three studies had conference abstracts. The eight early trials examined immediate insertion of different devices or insertion techniques. Most studies were published in the 1980s, some with limited reporting.Our sensitivity analysis included trials with sufficient outcome data and moderate or high quality evidence. Four newer trials comparing insertion times met the inclusion criteria. Two studies used the levonorgestrel-releasing intrauterine system (LNG-IUS) after vaginal delivery. The other two trials placed IUC after cesarean section; one used the CuT 380A intrauterine device (IUD) and the other used the LNG-IUS.A pilot trial compared immediate insertion versus early or standard insertion. In groups comparing immediate versus early insertion (N = 30), all women had the LNG-IUS inserted. By six months, the groups had the same expulsion rate and did not differ significantly in IUC use.For immediate versus standard insertion, we conducted meta-analyses of four trials. Insertion rates did not differ significantly between study arms. However, the trial from Uganda showed insertion was more likely for the immediate group, although the estimate was imprecise. In the meta-analysis, expulsion by six months was more likely for the immediate group, but the confidence interval was wide (OR 4.89, 95% CI 1.47 to 16.32; participants = 210; studies = 4). IUC use at six months was more likely with immediate insertion than with standard insertion (OR 2.04, 95% CI 1.01 to 4.09; participants = 243; studies = 4). Study arms did not differ in use at 3 or 12 months in individual small trials. AUTHORS' CONCLUSIONS: Recent trials compared different insertion times after vaginal or cesarean delivery. Evidence was limited because studies with full reports generally had small sample sizes. Overall, the quality of evidence was moderate; abstracts and older studies had limited reporting. Ongoing trials will add to the evidence, although some are small. Trials of adequate power are needed to estimate expulsion rates and side effects.The benefit of effective contraception immediately after delivery may outweigh the disadvantage of increased risk for expulsion. Frequent prenatal visits during the third trimester provide the opportunity to discuss effective contraceptive methods and desired timing for initiation. Clinical follow-up can help detect early expulsion, as can educating women about expulsion signs and symptoms.

Combined hormonal versus nonhormonal versus progestin-only contraception in lactation.

BACKGROUND: Postpartum contraception improves the health of mothers and children by lengthening birth intervals. For lactating women, contraception choices are limited by concerns about hormonal effects on milk quality and quantity and passage of hormones to the infant. Ideally, the contraceptive chosen should not interfere with lactation or infant growth. Timing of contraception initiation is also important. Immediately postpartum, most women have contact with a health professional, but many do not return for follow-up contraceptive counseling. However, immediate initiation of hormonal methods may disrupt the onset of milk production. OBJECTIVES: To determine the effects of hormonal contraceptives on lactation and infant growth SEARCH METHODS: We searched for eligible trials until 2 March 2015. Sources included the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, POPLINE, Web of Science, LILACS, ClinicalTrials.gov, and ICTRP. We also examined review articles and contacted investigators. SELECTION CRITERIA: We sought randomized controlled trials in any language that compared hormonal contraception versus another form of hormonal contraception, nonhormonal contraception, or placebo during lactation. Hormonal contraception includes combined or progestin-only oral contraceptives, injectable contraceptives, implants, and intrauterine devices.Trials had to have one of our primary outcomes: breast milk quantity or biochemical composition; lactation initiation, maintenance, or duration; infant growth; or timing of contraception initiation and effect on lactation. Secondary outcomes included contraceptive efficacy while breastfeeding and birth interval. DATA COLLECTION AND ANALYSIS: For continuous variables, we calculated the mean difference (MD) with 95% confidence interval (CI). For dichotomous outcomes, we computed the Mantel-Haenszel odds ratio (OR) with 95% CI. Due to differing interventions and outcome measures, we did not aggregate the data in a meta-analysis. MAIN RESULTS: In 2014, we added seven trials for a new total of 11. Five reports were published before 1985 and six from 2005 to 2014. They included 1482 women. Four trials examined combined oral contraceptives (COCs), and three studied a levonorgestrel-releasing intrauterine system (LNG-IUS). We found two trials of progestin-only pills (POPs) and two of the etonogestrel-releasing implant. Older studies often lacked quantified results. Most trials did not report significant differences between the study arms in breastfeeding duration, breast milk composition, or infant growth. Exceptions were seen mainly in older studies with limited information.For breastfeeding duration, two of eight trials indicated a negative effect on lactation. A COC study reported a negative effect on lactation duration compared to placebo but did not quantify results. Another trial showed a lower percentage of the LNG-IUS group breastfeeding at 75 days versus the nonhormonal IUD group (reported P < 0.05) but no significant difference at one year.For breast milk volume, two older studies indicated lower volume for the COC group versus the placebo group. One trial did not quantify results. The other showed lower means (mL) for the COC group, e.g. at 16 weeks (MD -24.00, 95% CI -34.53 to -13.47) and at 24 weeks (MD -24.90, 95% CI -36.01 to -13.79). Another four trials did not report any significant difference between the study groups in milk volume or composition with two POPs, a COC, or the etonogestrel implant.Seven trials studied infant growth; one showed greater weight gain (grams) for the etonogestrel implant versus no method for six weeks (MD 426.00, 95% CI 58.94 to 793.06) but less compared with depot medroxyprogesterone acetate (DMPA) from 6 to 12 weeks (MD -271.00, 95% CI -355.10 to -186.90). The others studied POPs, COCs versus POPs, or an LNG-IUS. AUTHORS' CONCLUSIONS: Results were not consistent across the 11 trials. The evidence was limited for any particular hormonal method. The quality of evidence was moderate overall and low for three of four placebo-controlled trials of COCs or POPs. The sensitivity analysis included six trials with moderate quality evidence and sufficient outcome data. Five trials indicated no significant difference between groups in breastfeeding duration (etonogestrel implant insertion times, COC versus POP, and LNG-IUS). For breast milk volume or composition, a COC study showed a negative effect, while an implant trial showed no significant difference. Of four trials that assessed infant growth, three indicated no significant difference between groups. One showed greater weight gain in the etonogestrel implant group versus no method but less versus DMPA.

Strategies for improving postpartum contraceptive use: evidence from non-randomized studies.

BACKGROUND: Nearly two-thirds of women in their first postpartum year have an unmet need for family planning. Adolescents often have repeat pregnancies within a year of giving birth. Women may receive counseling on family planning both antepartum and postpartum. Decisions about contraceptive use made right after counseling may differ considerably from actual postpartum use. In earlier work, we found limited evidence of effectiveness from randomized trials on postpartum contraceptive counseling. For educational interventions, non-randomized studies may be conducted more often than randomized trials. OBJECTIVES: We reviewed non-randomized studies of educational strategies to improve postpartum contraceptive use. Our intent was to examine associations between specific interventions and postpartum contraceptive use or subsequent pregnancy. SEARCH METHODS: We searched for eligible non-randomized studies until 3 November 2014. Sources included CENTRAL, PubMed, POPLINE, and Web of Science. We also sought current trials via ClinicalTrials.gov and ICTRP. For additional citations, we examined reference lists of relevant reports and reviews. SELECTION CRITERIA: The studies had to be comparative, i.e., have intervention and comparison groups. The educational component could be counseling or another behavioral strategy to improve contraceptive use among postpartum women. The intervention had to include contact within six weeks postpartum. The comparison condition could be another behavioral strategy to improve contraceptive use, usual care, other health education, or no intervention. Our primary outcomes were postpartum contraceptive use and subsequent pregnancy. DATA COLLECTION AND ANALYSIS: Two authors evaluated abstracts for eligibility and extracted data from included studies. We computed the Mantel-Haenszel odds ratio (OR) for dichotomous outcomes and the mean difference (MD) for continuous measures, both with 95% Confidence Intervals (CI). Where studies used adjusted analyses for continuous outcomes, we presented the results as reported by the investigators. Due to differences in interventions and outcome measures, we did not conduct meta-analysis. To assess the evidence quality, we used the Newcastle-Ottawa Quality Assessment Scale. MAIN RESULTS: Six studies met our inclusion criteria and included a total of 5143 women. Of three studies with self-reported pregnancy data, two showed pregnancy to be less likely in the experimental group than in the comparison group (OR 0.48, 95% CI 0.27 to 0.87) (OR 0.60, 95% CI 0.41 to 0.87). The interventions included a clinic-based counseling program and a community-based communication project.All studies showed some association of the intervention with contraceptive use. Two showed that treatment-group women were more likely to use a modern method than the control group: ORs were 1.77 (95% CI 1.08 to 2.89) and 3.08 (95% CI 2.36 to 4.02). In another study, treatment-group women were more likely than control-group women to use pills (OR 1.78, 95% CI 1.26 to 2.50) or an intrauterine device (IUD) (OR 3.72, 95% CI 1.27 to 10.86) but less likely to use and injectable method (OR 0.23, 95% CI 0.05 to 1.00). One study used a score for method effectiveness. The methods of the special-intervention group scored higher than those of the comparison group at three months (MD 13.26, 95% CI 3.16 to 23.36). A study emphasizing IUDs showed women in the intervention group were more likely to use an IUD (OR 1.79, 95% CI 1.20 to 2.69) and less likely to use no method (OR 0.48, 95% CI 0.31 to 0.75). In another study, contraceptive use was more likely among women in a health service intervention compared to women in a community awareness program at four months (OR 1.79, 95% CI 1.40 to 2.30) or women receiving standard care at 10 to 12 months (OR 2.08, 95% CI 1.58 to 2.74). That study was the only one with a specific component on the lactational amenorrhea method (LAM) that had sufficient data on LAM use. Women in the health service group were more likely than those in the community awareness group to use LAM (OR 41.36, 95% CI 10.11 to 169.20). AUTHORS' CONCLUSIONS: We considered the quality of evidence to be very low. The studies had limitations in design, analysis, or reporting. Three did not adjust for potential confounding and only two had sufficient information on intervention fidelity. Outcomes were self reported and definitions varied for contraceptive use. All studies had adequate follow-up periods but most had high losses, as often occurs in contraception studies.

Repeated use of pre- and postcoital hormonal contraception for prevention of pregnancy.

BACKGROUND: Repeated use of postcoital hormonal contraception is not currently recommended due to the higher risk of side effects and lower contraceptive effectiveness compared to other modern methods of contraception. However, emerging evidence indicates renewed interest in a regular coitally-dependent method of oral contraception. We evaluated the existing data on safety and effectiveness of pericoital use of levonorgestrel and other hormonal drugs to prevent pregnancy. OBJECTIVES: To determine the effectiveness and safety of repeated use of pre- and postcoital hormonal contraception for pregnancy prevention. SEARCH METHODS: We searched until 1 September 2014 for trials that tested repeated pre- and postcoital use of hormonal drugs for pregnancy prevention. Databases included CENTRAL, MEDLINE, and POPLINE. We searched for current trials via ClinicalTrials.gov and ICTRP. For the initial review, we also searched EMBASE, CINAHL, and LILACS, and wrote to researchers to identify other trials. SELECTION CRITERIA: We considered published and unpublished studies of repeated postcoital or immediately precoital use of hormonal drugs for contraception with pregnancy as an outcome. DATA COLLECTION AND ANALYSIS: Two authors independently confirmed eligibility and extracted data from the included studies. We calculated confidence intervals (CI) around individual study Pearl indices using a Poisson distribution. We presented individual study estimates and pooled estimates and their 95% CI, where appropriate. MAIN RESULTS: We found 22 trials that evaluated pericoital use of LNG and other hormonal drugs on a regular basis to prevent pregnancy. The studies included a total of 12,400 participants, and were conducted in Europe, Asia, and the Americas. The drugs and doses evaluated included levonorgestrel (LNG) 0.75 mg (11 studies), LNG in doses other than 0.75 mg (4 trials), and hormones other than LNG (7 trials). Outcomes included pregnancy rates, discontinuation, side effects, and acceptability.Pericoital levonorgestrel was reasonably efficacious and safe. The pooled Pearl Index for the 0.75 mg dose of LNG was 5.4 per 100 woman-years (95% CI 4.1 to 7.0). The pooled Pearl Index for all doses of LNG was 5.0 per 100 woman-years (95% CI 4.4 to 5.6). Other hormonal drugs appeared promising but most of them were not studied extensively. Menstrual irregularities were the most common side effects reported. However, the studies provided no consistent evidence of a relationship between bleeding abnormalities and either frequency of pill intake or total dose of the drug. Non-menstrual side effects were reportedly mild and not tabulated in most studies. Most women liked the pericoital method in spite of frequent menstrual irregularities. AUTHORS' CONCLUSIONS: The studies of pericoital LNG regimens provided promising results but many had serious methodological issues. Most reports were decades old and provided limited information. However, we considered the evidence to be moderate quality because of the large number of participants from diverse populations, the low pregnancy rates, and the consistent results across studies. Rigorous research is still needed to confirm the efficacy and safety of pericoital use of LNG as a primary means of contraception among women with infrequent intercourse. If the method is shown to be efficacious, safe and acceptable, the results may warrant revision of the current World Health Organization recommendations and marketing strategies.

Steroidal contraceptives: effect on bone fractures in women.

BACKGROUND: Steroidal contraceptive use has been associated with changes in bone mineral density in women. Whether such changes increase the risk of fractures later in life is not clear. Osteoporosis is a major public health concern. Age-related decline in bone mass increases the risk of fracture, especially of the spine, hip, and wrist. Concern about bone health influences the recommendation and use of these effective contraceptives globally. OBJECTIVES: Our aim was to evaluate the effect of using hormonal contraceptives before menopause on the risk of fracture in women. SEARCH METHODS: Through April 2014, we searched for studies of fracture or bone health and hormonal contraceptives in MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS, as well as ClinicalTrials.gov and ICTRP. We examined reference lists of relevant articles for other trials. For the initial review, we wrote to investigators to find additional trials. SELECTION CRITERIA: Randomized controlled trials (RCTs) were considered if they examined fractures, bone mineral density (BMD), or bone turnover markers in women with hormonal contraceptive use prior to menopause. Eligible interventions included comparisons of a hormonal contraceptive with a placebo or with another hormonal contraceptive that differed in terms of drug, dosage, or regimen. They also included providing a supplement to one group. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts identified through the literature searches. Mean differences were computed using the inverse variance approach. For dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) was calculated. Both included the 95% confidence interval (CI) and used a fixed-effect model. Due to differing interventions, no trials could be combined for meta-analysis. We applied principles from GRADE to assess the evidence quality and address confidence in the effect estimates. In addition, a sensitivity analysis included trials that provided sufficient data for this review and evidence of at least moderate quality. MAIN RESULTS: We found 19 RCTs that met our eligibility criteria. Eleven trials compared different combined oral contraceptives (COCs) or regimens of COCs; five examined an injectable versus another injectable, implant, or IUD; two studied implants, and one compared the transdermal patch versus the vaginal ring. No trial had fracture as an outcome. BMD was measured in 17 studies and 12 trials assessed biochemical markers of bone turnover. Depot medroxyprogesterone acetate (DMPA) was associated with decreased bone mineral density (BMD). The placebo-controlled trials showed BMD increases for DMPA plus estrogen supplement and decreases for DMPA plus placebo supplement. COCs did not appear to negatively affect BMD, and some formulations had more positive effects than others. However, no COC trial was placebo-controlled. Where studies showed differences between groups in bone turnover markers, the results were generally consistent with those for BMD. For implants, the single-rod etonogestrel group showed a greater BMD decrease versus the two-rod levonorgestrel group but results were not consistent across all implant comparisons.The sensitivity analysis included 11 trials providing evidence of moderate or high quality. Four trials involving DMPA showed some positive effects of an estrogen supplement on BMD, a negative effect of DMPA-subcutaneous on lumbar spine BMD, and a negative effect of DMPA on a bone formation marker. Of the three COC trials, one had a BMD decrease for the group with gestodene plus EE 15 µg. Another indicated less bone resorption in the group with gestodene plus EE 30 µg versus EE 20 µg. AUTHORS' CONCLUSIONS: Whether steroidal contraceptives influence fracture risk cannot be determined from existing information. The evidence quality was considered moderate overall, largely due to the trials of DMPA, implants, and the patch versus ring. The COC evidence varied in quality but was low overall. Many trials had small numbers of participants and some had large losses. Health care providers and women should consider the costs and benefits of these effective contraceptives. For example, injectable contraceptives and implants provide effective, long-term birth control yet do not involve a daily regimen. Progestin-only contraceptives are considered appropriate for women who should avoid estrogen due to medical conditions.

Steroidal contraceptives: effect on carbohydrate metabolism in women without diabetes mellitus.

BACKGROUND: Many hormonal contraceptives have been associated with changes in carbohydrate metabolism. Alterations may include decreased glucose tolerance and increased insulin resistance, which are risk factors for Type 2 diabetes mellitus and cardiovascular disease. These issues have been raised primarily with contraceptives containing estrogen. OBJECTIVES: To evaluate the effect of hormonal contraceptives on carbohydrate metabolism in healthy women and those at risk for diabetes due to overweight. SEARCH METHODS: In April 2014, we searched the computerized databases MEDLINE, POPLINE, CENTRAL, and LILACS for studies of hormonal contraceptives and carbohydrate metabolism. We also searched for clinical trials in ClinicalTrials.gov and ICTRP. The initial search also included EMBASE. SELECTION CRITERIA: All randomized controlled trials were considered if they examined carbohydrate metabolism in women without diabetes who used hormonal contraceptives for contraception. Comparisons could be a placebo, a non-hormonal contraceptive, or another hormonal contraceptive that differed in drug, dosage, or regimen. Interventions included at least three cycles. Outcomes included glucose and insulin measures. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts identified during the literature searches. The data were extracted and entered into RevMan. We wrote to researchers for missing data. For continuous variables, the mean difference (MD) was computed with 95% confidence interval (CI) using a fixed-effect model. For dichotomous outcomes, the Peto odds ratio with 95% CI was calculated. MAIN RESULTS: We found 31 trials that met the inclusion criteria. No new trials were eligible in 2014. Twenty-one trials compared combined oral contraceptives (COCs); others examined different COC regimens, progestin-only pills, injectables, a vaginal ring, and implants. None included a placebo. Of 34 comparisons, eight had any notable difference between the study groups in an outcome.Twelve trials studied desogestrel-containing COCs, and the few differences from levonorgestrel COCs were inconsistent. A meta-analysis of two studies showed the desogestrel group had a higher mean fasting glucose (MD 0.20; 95% CI 0.00 to 0.41). Where data could not be combined, single studies showed lower mean fasting glucose (MD -0.40; 95% CI -0.72 to -0.08) and higher means for two-hour glucose response (MD 1.08; 95% CI 0.45 to 1.71) and insulin area under the curve (AUC) (MD 20.30; 95% CI 4.24 to 36.36).Three trials examined the etonogestrel vaginal ring and one examined an etonogestrel implant. One trial showed the ring group had lower mean AUC insulin than the levonorgestrel-COC group (MD -204.51; 95% CI -389.64 to -19.38).Of eight trials of norethisterone preparations, five compared COCs and three compared injectables. In a COC trial, a norethisterone group had smaller mean change in glucose two-hour response than a levonorgestrel-COC group (MD -0.30; 95% CI -0.54 to -0.06). In an injectable study, a group using depot medroxyprogesterone acetate had higher means than the group using norethisterone enanthate for fasting glucose (MD 10.05; 95% CI 3.16 to 16.94), glucose two-hour response (MD 17.00; 95% CI 5.67 to 28.33), and fasting insulin (MD 3.40; 95% CI 2.07 to 4.73).Among five recent trials, two examined newer COCs with different estrogen types. One showed the group with nomegestrel acetate plus 17ß-estradiol had lower means than the levonorgestrel group for incremental AUC glucose (MD -1.43; 95% CI -2.55 to -0.31) and glycosylated hemoglobin (HbA1c) (MD -0.10; 95% CI -0.18 to -0.02). Two trials compared extended versus conventional (cyclic) regimens. With a dienogest COC, an extended-use group had greater mean change in AUC glucose (MD 82.00; 95% CI 10.72 to 153.28). In a small trial using two levonorgestrel COCs, the lower-dose group showed smaller mean change in fasting glucose (MD -3.00; 95% CI -5.89 to -0.11), but the obese and normal weight women did not differ significantly. AUTHORS' CONCLUSIONS: Current evidence suggests no major differences in carbohydrate metabolism between different hormonal contraceptives in women without diabetes. We cannot make strong statements due to having few studies that compared the same types of contraceptives. Many trials had small numbers of participants and some had large losses. Many of the earlier studies had limited reporting of methods.We still know very little about women at risk for metabolic problems due to being overweight. More than half of the trials had weight restrictions as inclusion criteria. Only one small trial stratified the groups by body mass index (obese versus normal).

Oral contraceptives for functional ovarian cysts.

BACKGROUND: Functional ovarian cysts are a common gynecological problem among women of reproductive age worldwide. When large, persistent, or painful, these cysts may require operations, sometimes resulting in removal of the ovary. Since early oral contraceptives were associated with a reduced incidence of functional ovarian cysts, many clinicians inferred that birth control pills could be used to treat cysts as well. This became a common clinical practice in the early 1970s. OBJECTIVES: This review examined all randomized controlled trials that studied oral contraceptives as therapy for functional ovarian cysts. SEARCH METHODS: In March 2014, we searched the databases of CENTRAL, PubMed, EMBASE, and POPLINE, as well as clinical trials databases (ClinicalTrials.gov and ICTRP). We also examined the reference lists of articles. For the initial review, we wrote to authors of identified trials to seek articles we had missed. SELECTION CRITERIA: We included randomized controlled trials in any language that included oral contraceptives used for treatment and not prevention of functional ovarian cysts. Criteria for diagnosis of cysts were those used by authors of trials. DATA COLLECTION AND ANALYSIS: Two authors independently abstracted data from the articles. One entered the data into RevMan and a second verified accuracy of data entry. For dichotomous outcomes, we computed the Mantel-Haenszel odds ratio with 95% confidence interval (CI). For continuous outcomes, we calculated the mean difference with 95% CI. MAIN RESULTS: We identified eight randomized controlled trials from four countries; the studies included a total of 686 women. Treatment with combined oral contraceptives did not hasten resolution of functional ovarian cysts in any trial. This held true for cysts that occurred spontaneously as well as those that developed after ovulation induction. Most cysts resolved without treatment within a few cycles; persistent cysts tended to be pathological (e.g., endometrioma or para-ovarian cyst) and not physiological. AUTHORS' CONCLUSIONS: Although widely used for treating functional ovarian cysts, combined oral contraceptives appear to be of no benefit. Watchful waiting for two or three cycles is appropriate. Should cysts persist, surgical management is often indicated.

Vasectomy occlusion techniques for male sterilization.

BACKGROUND: Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide, including vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), as well as vasectomy with vas irrigation or with fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the evidence from randomized controlled trials (RCTs). OBJECTIVES: The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization. SEARCH METHODS: In February 2014, we updated the searches of CENTRAL, MEDLINE, POPLINE and LILACS. We looked for recent clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform. Previous searches also included EMBASE. For the initial review, we searched the reference lists of relevant articles and book chapters. SELECTION CRITERIA: We included RCTs comparing vasectomy techniques, which could include suture ligature, surgical clips, thermal or electrocautery, chemical occlusion, vas plugs, vas excision, open-ended vas, fascial interposition, or vas irrigation. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts located in the literature searches. Two reviewers independently extracted data from articles identified for inclusion. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. Peto odds ratios (OR) with 95% confidence intervals (CI) were used for dichotomous outcomes, such as azoospermia. The mean difference (MD) was used for the continuous variable of operating time. MAIN RESULTS: Six studies met the inclusion criteria. One trial compared vas occlusion with clips versus a conventional vasectomy technique. No difference was found in failure to reach azoospermia (no sperm detected). Three trials examined vasectomy with vas irrigation. Two studies looked at irrigation with water versus no irrigation, while one examined irrigation with water versus the spermicide euflavine. None found a difference between the groups for time to azoospermia. However, one trial reported that the median number of ejaculations to azoospermia was lower in the euflavine group compared to the water irrigation group. One high-quality trial compared vasectomy with fascial interposition versus vasectomy without fascial interposition. The fascial interposition group was less likely to have vasectomy failure. Fascial interposition had more surgical difficulties, but the groups were similar in side effects. Lastly, one trial found that an intra-vas was less likely to produce azoospermia than was no-scalpel vasectomy. More men were satisfied with the intra-vas device, however. AUTHORS' CONCLUSIONS: For vas occlusion with clips or vasectomy with vas irrigation, no conclusions can be made as those studies were of low quality and underpowered. Fascial interposition reduced vasectomy failure. An intra-vas device was less effective in reducing sperm count than was no-scalpel vasectomy. RCTs examining other vasectomy techniques were not available. More and better quality research is needed to examine vasectomy techniques.

Scalpel versus no-scalpel incision for vasectomy.

BACKGROUND: Currently, the two most common surgical techniques for approaching the vas during vasectomy are the incisional method and the no-scalpel technique. Whereas the conventional incisional technique involves the use of a scalpel to make one or two incisions, the no-scalpel technique uses a sharp-pointed, forceps-like instrument to puncture the skin. The no-scalpel technique aims to reduce adverse events, especially bleeding, bruising, hematoma, infection and pain and to shorten the operating time. OBJECTIVES: The objective of this review was to compare the effectiveness, safety, and acceptability of the incisional versus no-scalpel approach to the vas. SEARCH METHODS: In February 2014, we searched the computerized databases of CENTRAL, MEDLINE, POPLINE and LILACS. We looked for recent clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform. Previous searches also included in EMBASE. For the initial review, we searched the reference lists of relevant articles and book chapters. SELECTION CRITERIA: Randomized controlled trials and controlled clinical trials were included in this review. No language restrictions were placed on the reporting of the trials. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts located in the literature searches and two authors independently extracted data from the articles identified for inclusion. Outcome measures included safety, acceptability, operating time, contraceptive efficacy, and discontinuation. We calculated Peto odds ratios (OR) with 95% confidence intervals (CI) for the dichotomous variables. MAIN RESULTS: Two randomized controlled trials evaluated the no-scalpel technique and differed in their findings. The larger trial demonstrated less perioperative bleeding (OR 0.49; 95% CI 0.27 to 0.89) and pain during surgery (OR 0.75; 95% CI 0.61 to 0.93), scrotal pain (OR 0.63; 95% 0.50 to 0.80), and incisional infection (OR 0.21; 95% CI 0.06 to 0.78) during follow up than the standard incisional group. Both studies found less hematoma with the no-scalpel technique (OR 0.23; 95% CI 0.15 to 0.36). Operations using the no-scalpel approach were faster and had a quicker resumption of sexual activity. The smaller study did not find these differences; however, the study could have failed to detect differences due to a small sample size as well as a high loss to follow up. Neither trial found differences in vasectomy effectiveness between the two approaches to the vas. AUTHORS' CONCLUSIONS: The no-scalpel approach to the vas resulted in less bleeding, hematoma, infection, and pain as well as a shorter operation time than the traditional incision technique. No difference in effectiveness was found between the two approaches.