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OBJECTIVE: While self-injection of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) has well-documented benefits, uptake may be improved by addressing client concerns such as fear of self-injury and low self-efficacy. However, current training materials for family planning providers do not address these concerns. We used an iterative process with family planning providers and clients, male community leaders and partners, and stakeholders in Malawi to develop a counseling message addressing user-centered concerns about self-injection. We report on our testing of the effectiveness of this evidence-based message for increasing self-injection uptake in the context of full method choice. METHODS: We randomized 60 public facilities across two districts in southern Malawi to orient their providers to the message (treatment) or not (control). After strengthening data quality, we extracted routine service delivery data from the facilities six months before and after introducing the message. We compared pre- and post-orientation trends for the treatment and control groups using generalized linear mixed models. We conducted eight focus group discussions with a sample of providers oriented to the message. RESULTS: The message was feasible to implement and highly acceptable to providers. During June 2020-June 2021, 16,593 new clients used injectables in Mangochi district (52% DMPA-SC; 15% self-injected). In Thyolo district, 7,761 new clients used injectables during July 2020-July 2021 (29% DMPA-SC; 14% self-injected). We observed high variability in number of clients and self-injection uptake across facilities and over time, indicating inconsistent offering of self-injection. In both districts, we found significant increases in self-injection in treatment facilities after message introduction. However, this increase was not sustained, especially when DMPA-SC was unavailable or about to expire. CONCLUSION: Based on the study findings, we recommend the evidence-based message be used in programs offering DMPA-SC self-injection services. However, effective use of the message is contingent upon a consistent supply of DMPA-SC.
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Anticoncepcionais Femininos , Acetato de Medroxiprogesterona , Feminino , Humanos , Masculino , Anticoncepção , Aconselhamento , Injeções Subcutâneas , Malaui , AutoadministraçãoRESUMO
Achieving the 95-95-95 UNAIDS targets requires meeting the needs of adolescents, however we lack evidenced-based approaches to improving adolescent adherence to antiretroviral therapy (ART), increasing viral suppression, and supporting general wellbeing. We developed Family Connections as a group intervention for adolescents and their adult caregivers and conducted a randomized controlled trial in Ndola, Zambia to test feasibility and acceptability. Fifty pairs (n = 100) of adolescents (15-19 years and on ART ≥ 6 months) and their caregivers were randomly assigned either to the intervention consisting of 10 group sessions over 6 months, or to a comparison group, which received the usual care. Each pair completed baseline and endline surveys, with adolescents also undergoing viral load testing. Of the 24-intervention adolescent/caregiver pairs, 88% attended at least eight group sessions. Most adolescents (96%) and all caregivers would recommend Family Connections to peers. Adolescent viral failure decreased but did not significantly differ by study group. Adolescents in the intervention group showed a greater reduction in HIV-related feelings of worthlessness and shame than the comparison group. The feasibility, acceptability, and the positive trend toward significantly reducing internalized stigma, generated by this Family Connections pilot study, contributes valuable data to support adolescent/caregiver approaches that use peer groups.
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Cuidadores , Infecções por HIV , Adolescente , Adulto , Estudos de Viabilidade , Infecções por HIV/tratamento farmacológico , Humanos , Projetos Piloto , ZâmbiaRESUMO
INTRODUCTION: In Senegal, discontinuation due to sides effects of long-acting, reversible contraceptives (LARCs) is relatively low; 5% of new implant acceptors and 11% of new IUD acceptors stop using in their first year because of health or side effect concerns. This study investigated factors associated with LARC discontinuation in the first 12 months of use in Senegal and explored how LARC users cope with side effects. METHODS: This mixed-method study involved quantitative interviews at five time points with LARC acceptors recruited from three service channels between February 2018 and March 2019. Qualitative interviews were conducted in August 2018 with a subset of those who experienced side effects. Logistic regression models identified factors associated with discontinuation due to side effects and discontinuation for any reason. Twelve-month discontinuation rates due to side effects were also estimated using a cumulative incidence function (CIF) approach to account for time to discontinuation. RESULTS: In logistic models, method choice (IUD or implant) [OR = 3.15 (95% CI: 1.91-5.22)] and parity [OR = 0.81 (95% CI: 0.7-0.94)] were associated with discontinuation due to side effects; IUD users and women with fewer children were more likely to discontinue. Results for all-cause discontinuation were similar: method choice [OR = 2.39 (95% CI: 1.6-3.58)] and parity [OR = 0.86 (95% CI: 0.77-0.96)] were significant predictors. The 12-month side effect CIF discontinuation rate was 11.2% (95% CI: 7.9-15.0%) for IUDs and 4.9% (95% CI: 3.5-6.6%) for implants. Side effect experiences varied, but most women considered menstrual changes the least acceptable. No statistically significant differences across services channels were observed. CONCLUSIONS: In this study in Senegal, the choice between implants and IUDs had a significant impact on continuation, and women with more children continued LARC methods longer, despite side effects.
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Background: Multisectoral approaches are thought necessary to prevent HIV among adolescents. We examined whether an economic strengthening (ES) and an HIV-prevention education intervention improved outcomes when combined versus separately. Methods: We conducted a full-factorial randomised controlled study to randomise participants into all possible intervention groups based on the two interventions: economic strengthening only (ES-only), HIV-prevention only (HIV-only), both interventions combined (ES+HIV) and no intervention (control). We measured sexually transmitted infections (STIs), self-reported economic and sexual behaviours/knowledge, and pregnancy at a pre-intervention and two post-intervention assessments. Eligible participants were adolescents 14 to 17 years old from a programme supporting vulnerable families in Gauteng Province, South Africa. We estimated intervention effects using repeated measures, generalised linear mixed models. Results: A total of 1773 adolescents participated (57% female). ES+HIV adolescents had the lowest STI prevalence at first endline; however, the comparison with the control was not significant (OR 0.62, 95% CI 0.27 to 1.41). ES-only or HIV-only groups were not significantly better than the control on STI prevalence (OR 1.53, 95% CI 0.73 to 3.20 and OR 1.47, 95% CI 0.69 to 3.12, respectively). STI prevalence became more similar among the groups at second endline.ES-only adolescents were more likely to participate in savings groups (p=0.004) and plan to save for education (p=0.001) versus the control. ES+HIV adolescents were more likely to plan to save for education versus the control (p=0.001) and HIV-only groups (p=0.002) but did not differ significantly from the ES-only group (p=0.803). The ES+HIV intervention's effect on HIV knowledge was significant compared with the control (p=0.03) and ES-only groups (p<0.001), but not when compared with the HIV-only group (p=0.091). Effects on pregnancy, sexual behaviours or other economic behaviours were not significant. Conclusions: We could not confirm the ES and HIV interventions, separately or combined, were effective to reduce STI prevalence. Evaluations of multicomponent interventions should use full-factorial designs to fully assess effects. Trial registration number: NCT02888678.
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Infecções por HIV , Infecções Sexualmente Transmissíveis , Adolescente , Feminino , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Humanos , Masculino , Gravidez , Prevalência , Infecções Sexualmente Transmissíveis/epidemiologia , Infecções Sexualmente Transmissíveis/prevenção & controle , África do Sul/epidemiologiaRESUMO
BACKGROUND: Afghanistan has high maternal and infant mortality which is in part driven by high fertility and low modern contraceptive use. Using modern contraceptive methods can reduce maternal and infant mortality, however there are several barriers to modern contraceptive use in Afghanistan. Married men have the potential to hinder or facilitate their wives' contraceptive use. Internally displaced persons (IDP), a growing population in Afghanistan, are rarely included in reproductive health research. We explored whether married men's, including IDPs', gender-related attitudes and other factors were associated with reported modern contraceptive use to inform programming to meet reproductive health needs of married couples. METHODS: Cross-sectional study using data from 885 married men determined to have contraceptive need in seven Afghan provinces. We explored associations between sociodemographic factors, IDP status, wives' involvement in household decision-making and men's attitudes towards intimate partner violence (IPV) with reported modern contraceptive use using logistic regression analysis. RESULTS: Most men (78%) had ≥2 children, 60% reported any formal education, and 30% reported being IDPs. Only 38% of married men and 24% of IDPs with contraceptive need reported using modern contraception with their wives. Most (80% overall, 63% of IDPs) reported their wives' involvement in some/all household decisions, while 47% overall and 57% of IDPs reported IPV was justified in one or more listed circumstances. In bivariate analysis, men responding that IPV was not justified in any listed circumstance were more likely and IDPs less likely to report modern contraceptive use. In multivariable analysis, involvement by wives in household decision-making (AOR 2.57; 95% CI: 1.51, 4.37), owning a radio and/or television (AOR 1.69; 95% CI: 1.10, 2.59), having more children, age, and province of interview were independently associated with reported modern contraceptive use, while IDP status was not. CONCLUSIONS: Our findings reflect positive associations between wives' participation in household decisions and mass media exposure (television/radio ownership) with reported modern contraceptive use. Reproductive health initiatives engaging men to promote communication within couples and through mass media channels may further increase modern contraceptive use and advance Afghanistan's family planning goals. As fewer IDPs owned a radio/television, additional outreach methods should be tested for this group.
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Comportamento Contraceptivo/psicologia , Conhecimentos, Atitudes e Prática em Saúde , Violência por Parceiro Íntimo/psicologia , Casamento/psicologia , Homens/psicologia , Adolescente , Adulto , Afeganistão , Fatores Etários , Estudos Transversais , Fertilidade , Inquéritos Epidemiológicos , Humanos , Masculino , Pessoa de Meia-Idade , Refugiados/psicologia , População Rural , Adulto JovemRESUMO
BACKGROUND: Maternal morbidity is common in Bangladesh, where the maternal mortality rate has plateaued over the last 6 years. Maternal undernutrition and micronutrient deficiencies contribute to morbidity, but few interventions have measured maternal outcomes. We compared reported prevalence of antepartum, intrapartum, and postpartum complications among recently delivered women between maternal nutrition intervention and control areas in Bangladesh. METHODS AND FINDINGS: We conducted a cross-sectional assessment nested within a population-based cluster-randomized trial comparing a nutrition counseling and micronutrient supplement intervention integrated within a structured home-based maternal, newborn, and child health (MNCH) program to the MNCH program alone in 10 sub-districts each across 4 Bangladesh districts. Eligible consenting women, delivering within 42-60 days of enrollment and identified by community-level health workers, completed an interviewer-administered questionnaire detailing the index pregnancy and delivery and allowed review of their home-based care register. We compared pooled and specific reported antepartum, intrapartum, and postpartum complications between study groups using hierarchical logistic regression. There were 594 women in the intervention group and 506 in the control group; overall, mean age was 24 years, 31% were primiparas, and 39% reported facility-based delivery, with no significant difference by study group. There were no significant differences between the intervention and control groups in household-level characteristics, including reported mean monthly income (intervention, 6,552 taka, versus control, 6,017 taka; p = 0.48), having electricity (69.6% versus 71.4%, p = 0.84), and television ownership (41.1% versus 38.7%, p = 0.81). Women in the intervention group had higher recorded iron and folic acid and calcium supplement consumption and mean dietary diversity scores, but reported anemia rates were similar between the 2 groups (5.7%, intervention; 6.5%, control; p = 0.83). Reported antepartum (69.4%, intervention; 79.2%, control; p = 0.12) and intrapartum (41.4%, intervention; 48.5%, control; p = 0.18) complication rates were high and not significantly different between groups. Reported postpartum complications were significantly lower among women in the intervention group than the control group (33.5% versus 48.2%, p = 0.02), and this difference persisted in adjusted analysis (adjusted odds ratio [AOR] = 0.51, 95% CI 0.32-0.82; p < 0.001). For specific conditions, odds of retained placenta (AOR = 0.35, 95% CI 0.19-0.67; p = 0.001), postpartum bleeding (AOR = 0.37, 95% CI 0.15-0.92; p = 0.033), and postpartum fever/infection (AOR = 0.27, 95% CI 0.11-0.65; p = 0.001) were significantly lower in the intervention group in adjusted analysis. There were no significant differences in reported hospitalization for antepartum (49.8% versus 45.1%, p = 0.37), intrapartum (69.9% versus 59.8%, p = 0.18), or postpartum (36.1% versus 29.9%, p = 0.49) complications between the intervention and control groups. The main limitations of this study are outcome measures based on participant report, non-probabilistic selection of community-level workers' catchment areas for sampling, some missing data for variables derived from secondary sources (e.g., dietary diversity score), and possible recall bias for reported dietary intake and supplement use. CONCLUSIONS: Reported overall postpartum and specific intrapartum and postpartum complications were significantly lower for women in intervention areas than control areas, despite similar rates of facility-based delivery and hospitalization for reported complications, in this exploratory analysis. Maternal nutrition interventions providing intensive counseling and micronutrient supplements may reduce some pregnancy complications or impact women's ability to accurately recognize complications, but more rigorous evaluation is needed for these outcomes.
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Suplementos Nutricionais , Fenômenos Fisiológicos da Nutrição Materna , Micronutrientes/administração & dosagem , Complicações na Gravidez/epidemiologia , Adulto , Bangladesh/epidemiologia , Análise por Conglomerados , Agentes Comunitários de Saúde , Aconselhamento , Estudos Transversais , Dieta , Feminino , Promoção da Saúde/métodos , Humanos , Mortalidade Materna , Período Pós-Parto , Gravidez , Adulto JovemRESUMO
CONTEXT: Short pregnancy intervals can contribute to maternal and child morbidity and mortality. No previous research has explored factors associated with short pregnancy intervals among young women in Uganda, where adolescent pregnancy and short birth intervals are common. METHODS: Data on 626 married or cohabiting women aged 15-22 with one or two previous pregnancies were drawn from the 2011 Uganda Demographic and Health Survey. Bivariate and multivariable logistic regression analyses were used to examine characteristics associated with rapid repeat pregnancy, defined in two ways: a pregnancy occurring within 24 months or 12 months of a prior pregnancy outcome. RESULTS: Among women, 74% and 37% had experienced a rapid repeat pregnancy within 24 months and 12 months, respectively. Rural women were more likely than urban women to have had a rapid repeat pregnancy within 24 months (odds ratio, 2.4). Women aged 15-17 and those 18 or older at first union were more likely than women younger than 15 to have had a rapid repeat pregnancy within 24 months (3.8 and 3.4); those whose partner had at least a secondary education had lower odds than others of the outcome (0.6). The odds of rapid repeat pregnancy increased with the number of months between marriage and first birth (1.05). Variables associated with rapid repeat pregnancy within 12 months included urban-rural residence, region, age at first union and marriage-to-birth interval. CONCLUSIONS: Efforts to reduce rapid repeat pregnancy among young women in Uganda should focus on rural areas. Strategies to reach women during antenatal care and the postpartum period after their first birth should be prioritized.
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Intervalo entre Nascimentos/etnologia , Intervalo entre Nascimentos/estatística & dados numéricos , Gravidez na Adolescência/etnologia , Gravidez na Adolescência/estatística & dados numéricos , Adolescente , Adulto , Feminino , Humanos , Gravidez , Análise de Regressão , Fatores de Risco , População Rural , Fatores Socioeconômicos , Maus-Tratos Conjugais/estatística & dados numéricos , Inquéritos e Questionários , Uganda/epidemiologia , População Urbana , Adulto JovemRESUMO
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.
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Índice de Massa Corporal , Anticoncepção/métodos , Anticoncepcionais Femininos/administração & dosagem , Obesidade , Taxa de Gravidez , Peso Corporal , Feminino , Humanos , Sobrepeso , Gravidez , Gravidez não Planejada , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
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.
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Comportamento Contraceptivo , Gravidez na Adolescência/prevenção & controle , Serviços de Saúde Escolar , Infecções Sexualmente Transmissíveis/prevenção & controle , Adolescente , Preservativos/estatística & dados numéricos , Anticoncepção/métodos , Anticoncepção Pós-Coito/estatística & dados numéricos , Feminino , Humanos , Masculino , Gravidez , Avaliação de Programas e Projetos de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Instituições Acadêmicas , Educação Sexual/métodos , Adulto JovemRESUMO
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.
Assuntos
Dispositivos Intrauterinos/efeitos adversos , Dor/tratamento farmacológico , Anti-Inflamatórios não Esteroides/uso terapêutico , Feminino , Humanos , Ibuprofeno/uso terapêutico , Lidocaína/uso terapêutico , Misoprostol/uso terapêutico , Naproxeno/uso terapêutico , Ocitócicos/uso terapêutico , Dor/prevenção & controle , Prilocaína/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
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.