Postpartum contraceptive counseling for first-time adolescent mothers: a randomized controlled trial.

PURPOSE: Rapid repeat pregnancy is common among adolescent mothers and is associated with increased risks of adverse perinatal and maternal outcomes. Increasing contraceptive uptake among postpartum adolescents may decrease these outcomes through pregnancy prevention. This randomized controlled trial of 100 postpartum adolescent women assessed the effect of a standardized immediate postpartum contraceptive counseling intervention emphasizing healthy birth spacing and the use of long-acting reversible contraceptives (LARC). METHODS: After a baseline survey about reproductive health and pregnancy intentions, all subjects received routine postpartum contraceptive counseling. The intervention group also received the standardized counseling intervention. All participants had access to immediate postpartum contraceptive implant initiation or to intrauterine device (IUD) insertion at postpartum follow-up. Contraceptive use and repeat pregnancy were assessed quarterly for 12 months. Differences in repeat pregnancy, as well as contraceptive initiation, continuation, and satisfaction were analyzed. RESULTS: There was no difference in repeat pregnancy or contraceptive initiation, continuation or satisfaction between the study groups. However, regardless of group assignment, all subjects who desired the contraceptive implant used the method, compared to 15% of subjects who desired the IUD (p < 0.001). Three pregnancies occurred among subjects who desired the IUD versus none amongst subjects who desired the implant (p = 0.10). CONCLUSIONS: This standardized postpartum contraceptive counseling intervention did not affect teens' repeat pregnancies or contraceptive use. However, immediate postpartum availability of the contraceptive implant was associated with increased utilization of this method when compared to the IUD. Future postpartum contraceptive efforts should investigate procedures to improve teens' access to postpartum contraception. CLINICALTRIALS. GOV IDENTIFIER: NCT01814930.

Gestational hormone trajectories and early pregnancy failure: a reassessment.

BACKGROUND: Studies have commonly assessed the endocrinolgical status of women once miscarriage is threatened or suspected; few studies have explored the antecedent hormonal environment or used a longitudinal strategy. Using refined statistical techniques, we sought to re-evaluate whether gestational hormone trajectories in early pregnancy can identify future miscarriage in asymptomatic pregnancies. METHODS: This prospective cohort study followed 105 women over-conception; 72 had normal term pregnancy outcomes while 33 experienced early pregnancy failure between 35 and 115 days of gestation. Participants attended a pre-conception and antenatal clinic at Newcastle University, United Kingdom (UK). Evaluation methods included ultrasound, clinical assessments of pregnancy progress and serial measurements of gestational hormones by radioimmunoassays. Linear mixed-effects regression analysis examined hormone relationships with pregnancy outcomes. RESULTS: Detailed longitudinal illustration of gestational hormones, antecedent to miscarriage indications, revealed early pathophysiological trends. In particular, oestradiol showed as marked a deviation from normal as progesterone before miscarriage was evident, reflecting a deficiency in the ovarian response to rising human chorionic gonadotrophin (hCG) levels. Regression analysis provided equations for gestational hormone slopes that significantly differentiated asymptomatic women with subsequent early pregnancy failure, compared to women with normal term pregnancies. Both progesterone and oestradiol displayed negative mean slopes in pregnancies destined for failure; in this group, both human placental lactogen (hPL) and hCG revealed mean positive trajectories that imitated normal pregnancies but at slower rates of increase. CONCLUSIONS: Oestradiol, progesterone and hCG trajectories, from 50 days of gestation, have good potential for revealing pathophysiology and for identifying which asymptomatic pregnancies are destined for subsequent failure. In asymptomatic patients where there is concern about viability and ultrasound diagnosis is ambiguous, a combined hormonal profile could contribute to guiding patient care decisions.

Postpartum adolescents' contraceptive counselling preferences.

OBJECTIVES: The optimal approach for provision and timing of postpartum contraceptive counselling for adolescents has not been established. To reduce repeat pregnancies from current USA levels of nearly 20%, a better understanding is needed of postpartum adolescent females' preferences regarding contraceptive counselling and delivery. METHODS: Semi-structured interviews with 30 USA postpartum teens (97% Black) explored pregnancy prevention and contraceptive counselling. Transcripts were independently coded by two researchers and inter-rater reliability calculated using Kappa coefficients. With a standard content analysis approach, common themes were identified, coded and summarized. RESULTS: Findings indicated pregnancy prevention was important - two thirds of subjects reported becoming pregnant 'too soon', almost all did not desire another child for at least 6 years and most indicated that pregnancy prevention was either 'very' or 'extremely' important right now. The subjects described doctors and their prenatal clinic as their most accurate sources of contraception information, but stated that doctors and parents were the most helpful sources. All were comfortable discussing contraception with providers and had a desire for shared decision making. While many had received written materials, most preferred in-person contraceptive counselling. Optimally, participants suggested that contraceptive counselling would be provided by a physician, begin antepartum and almost all preferred to leave the hospital with their chosen method of contraception. CONCLUSIONS: Pregnancy prevention is important for postpartum adolescents as most desired to delay future childbearing. In-person contraceptive counselling should begin in the antepartum period and include provision of contraception prior to discharge.

A self-assessment efficacy tool for spermicide contraceptive users.

BACKGROUND: Easily accessible contraceptive methods, such as chemical and barrier methods, are used currently by approximately 1 in 6 women who use contraception in the United States. Even in the face of suboptimal effectiveness, coitally dependent methods likely will always have a role in fertility management. Because most contraceptive efficacy stratifications use population-based data, for women to make informed decisions about the individual fit of a contraceptive method, better evidence-based, user-friendly tools are needed. OBJECTIVES: Spermicides are a readily available, over-the counter, woman-controlled contraceptive method, but their effectiveness is user-dependent. Patient-decision aids for spermicides and other barrier methods are not well-developed, and overall failure rates could be improved by aids that account for individual characteristics. We sought to derive a prediction rule for successful use of spermicides for pregnancy prevention and to convert those data to a point-of-care instrument that women can use when they are considering spermicide use during contraceptive decision-making. STUDY DESIGN: We pooled local data from 3 randomized clinical trials that were published in 2004, 2007, and 2010 that tested spermicide efficacy. We constructed a prediction rule for unintended pregnancy using bootstrap validation and developed a scoring system. RESULTS: Data from 621 women showed a mean age of 29 years; 49% of the women were African American, and 43% were white. The overall pregnancy rate was 10.3% (95% confidence interval, 7.9-12.7) over 6 months. In adjusted logistic regression, age >35 years was protective against pregnancy (odds ratio, 0.19; 95% confidence interval, 0.06-0.58; P = .003), and multigravidity was associated with high failure rates (odds ratio, 7.24; 95% confidence interval, 3.04-17.3; P < .001). These risk factors (together with frequency of unprotected sex) were used in a model that maximized sensitivity for pregnancy prediction to compute the predicted probability of unintended pregnancy for each woman. This model was 97% accurate in predicting women who had a <5% pregnancy risk while using spermicides. CONCLUSION: Using prospectively collected data, we built a simple risk calculator for contraceptive failure that women can consult when considering spermicide use. This instrument could support patient-centered contraceptive decision-making.

Cell-free DNA fetal fraction and preterm birth.

BACKGROUND: Cell-free deoxyribonucleic acid (DNA) is increasingly being used to screen for fetal aneuploidy. The majority of fetal cell-free DNA in the maternal blood results from release from the syncytiotrophoblast as a result of cellular apoptosis and necrosis. Elevated levels of fetal cell-free DNA may be indicative of underlying placental dysfunction, which has been associated with preterm birth. Preliminary studies have demonstrated that fetal cell-free DNA is increased in pregnancies complicated by spontaneous preterm birth. There are limited data on the association between fetal cell-free DNA levels and fetal fraction and preterm birth in asymptomatic women in the first and second trimesters. Preliminary studies have failed to find an association between first-trimester cell-free DNA levels and preterm birth, whereas there is conflicting evidence as to whether elevated second-trimester cell-free DNA is associated with a subsequent spontaneous preterm birth clinical event. OBJECTIVE: The objective of the study was to evaluate the association between first- and second-trimester cell-free DNA fetal fraction and preterm birth. STUDY DESIGN: This was a retrospective cohort study of women with singleton pregnancies at increased risk for aneuploidy who had cell-free DNA testing at 10-20 weeks' gestation between October 2011 and May 2014. The cohort was subdivided by gestational age at the time of cell-free DNA testing (10-14 weeks or 14.1-20 weeks). The primary outcome was preterm birth less than 37 weeks' gestation, and the secondary outcomes were preterm birth at less than 34 weeks' gestation and spontaneous preterm birth at less than 37 and 34 weeks' gestation. RESULTS: Among 1349 pregnancies meeting inclusion criteria 119 (8.8 %) had a preterm birth prior to 37 weeks with 49 cases (3.6 %) delivering prior to 34 weeks. Whereas there was no significant association between fetal fraction and the preterm birth outcomes for those who underwent cell-free DNA testing at 10-14 weeks' gestation, there were significant associations among those screened at 14.1-20.0 weeks' gestation. Fetal fraction greater than or equal to the 95th percentile at 14.1-20.0 weeks' gestation was associated with an increased risk for preterm birth less than 37 and 34 weeks' gestation (adjusted odds ratio, 4.59; 95% confidence interval, 1.39-15.2; adjusted odds ratio, 22.0; 95% confidence interval, 5.02-96.9). CONCLUSION: Elevated fetal fraction levels at 14.1-20.0 weeks' gestation were significantly associated with an increased incidence of preterm birth. Our findings warrant future exploration including validation in a larger, general population and investigation of the potential mechanisms that may be responsible for the initiation of preterm labor associated with increased fetal cell-free DNA.

Medical management of ectopic pregnancy with single-dose and 2-dose methotrexate protocols: human chorionic gonadotropin trends and patient outcomes.

BACKGROUND: Ectopic pregnancy, although rare, is an important cause of female morbidity and mortality and early, effective treatment is critical. Systemic methotrexate has become widely accepted as a safe and effective alternative to surgery in the stable patient. As the number and timing of methotrexate doses differ in the 3 main medical treatment regimens, one might expect trends in serum human chorionic gonadotropin and time to resolution to vary depending on protocol. Furthermore, human chorionic gonadotropin trends and time to resolution may predict ultimate treatment success. OBJECTIVE: This study hypothesized that the 2-dose methotrexate protocol would be associated with a faster initial decline in serum human chorionic gonadotropin levels and a shorter time to resolution compared to the single-dose protocol. STUDY DESIGN: A prospective multicenter cohort study included clinical data from women who received medical management for ectopic pregnancy. Rates of human chorionic gonadotropin change and successful pregnancy resolution were assessed. Propensity score modeling addressed confounding by indication, the potential for differential assignment of patients with better prognosis to the single-dose methotrexate protocol. RESULTS: In all, 162 ectopic pregnancies were in the final analysis; 114 (70%) were treated with the single-dose methotrexate and 48 (30%) with the 2-dose protocol. Site, race, ethnicity, and reported pain level were associated with differential protocol allocation (P < .001, P = .011, P < .001, and P = .035, respectively). Women had similar initial human chorionic gonadotropin levels in either protocol but the mean rate of decline of human chorionic gonadotropin from day 0 (day of administration of first dose of methotrexate) to day 7 was significantly more rapid in women who received the single-dose protocol compared to those treated with the 2-dose protocol (mean change -31.3% vs -10.4%, P = .037, adjusted for propensity score and site). The 2 protocols had no significant differences in success rate or time to resolution. CONCLUSION: In a racially and geographically diverse group of women, the single- and double-dose methotrexate protocols had comparable outcomes. The more rapid human chorionic gonadotropin initial decline in the single-dose group suggested these patients were probably at lower risk for ectopic rupture than those getting the 2-dose protocol. A prospective randomized controlled design is needed to remove confounding by indication.

Integration of family planning services into health care for HIV-positive women in Botswana.

OBJECTIVE: To create and assess a clinic model to address the unmet need for effective contraception among women living with HIV in Botswana, where half of all pregnancies are unintended and 30% of women of reproductive age are living with HIV. METHODS: We introduced family planning services into an HIV clinic in Gaborone, Botswana. Our intervention gave HIV providers brief training on contraceptive counseling plus the option of immediate referral of interested patients to an on-site contraception provider. We administered a survey to patients and providers before and after intervention. Patients were female, aged 18-45 years and using antiretrovirals. RESULTS: At baseline, 6% of 141 patients discussed contraception with their HIV-care provider, compared with 61% of 107 post intervention (P < 0.001). At baseline, 6% of patients reported wanting to use long-acting reversible contraception (LARC). Post intervention, 45% of patients chose to meet with the contraception provider, and 29% wanted to use LARC (P < 0.001 versus baseline). All providers strongly agreed that they were better informed about contraception post intervention and were satisfied with their ability to counsel and refer women for contraception. CONCLUSIONS: Provision of on-site contraceptive services in this HIV clinic encouraged family planning discussions and increased interest in LARC.

Implementing an advance emergency contraception policy: what happens in the real world?

CONTEXT: Advance provision of emergency contraception increases the likelihood of its use, yet little is known about the factors that influence successful implementation of an advance provision policy in publicly funded family planning clinics. METHODS: Data on knowledge of, attitudes toward and use of emergency contraception were collected from 211 patients attending four Title X-funded clinics in Pennsylvania in 2001-2002. In addition, 22 staff from the four clinics were interviewed regarding barriers to and facilitators of advance provision in 2004-2005, and 111 staff from 46 clinics completed related surveys in 2005. Qualitative data underwent content analysis, and frequencies and bivariate associations between variables were calculated for the survey data. RESULTS: Most patients said they would use emergency contraception (80%) and believed it should be easy to obtain (93%), although 46% thought it is a form of abortion. Patients' familiarity with the method, attitudes toward it and self-efficacy regarding its use were not associated with most demographic or reproductive health characteristics. While nearly all interviewed staff endorsed routine advance provision, only about half of survey respondents offered it "very often" at patients' initial or annual visits. Barriers to advance provision included staff prejudgment of patients' needs and ability to use the method, time constraints and inefficiencies in clinic procedures. CONCLUSIONS: Strategies that may facilitate advance provision of emergency contraception include emphasizing the need for staff to offer it during all patient visits, providing patient-friendly information and streamlining clinic procedures.

Characteristics associated with emergency contraception use by family planning patients: a prospective cohort study.

CONTEXT: Little is known about how written family planning clinic policy regarding emergency contraception, as well as personal characteristics, behaviors and attitudes, may influence a woman to use emergency contraception. METHODS: Between June 2001 and July 2002, women attending publicly funded family planning clinics in Pennsylvania were enrolled in an 18-month longitudinal study. Half attended clinics with a policy of offering emergency contraception in advance; the remainder had only emergent access to the drug. After providing baseline data, women completed monthly automated phone surveys about recent sexual activity, contraceptive use and attitudes toward pregnancy. Characteristics associated with recent use of emergency contraception were examined using multivariate logistic regression. RESULTS: Responses to 3,700 phone surveys from 729 women showed that 25% of those who attended clinics offering advance access used emergency contraception at least once during the study, compared with 8% who attended emergent access clinics. Women attending advance access clinics had significantly elevated odds of having used emergency contraception in the past month (odds ratio, 2.6). Other characteristics positively associated with the likelihood of recent emergency contraception use were familiarity with the drug, having a new sex partner and having unprotected sex at least once (2.0 each); negative feelings toward pregnancy (1.4); and using condoms as one's main contraceptive method (1.8). CONCLUSIONS: In addition to discussing and offering advance emergency contraception, providers should further explore specific behaviors and attitudes associated with emergency contraception use.

Treatment Decisions at the Time of Miscarriage Diagnosis.

OBJECTIVE: To describe the factors patients and physicians prioritize during first-trimester miscarriage management and assess what drives satisfaction with care. METHODS: We conducted a mixed-methods study of clinically stable women seeking surgical, medical, or expectant miscarriage treatment. Women with first-trimester fetal demise or anembryonic gestation (N=55) completed demographic and psychosocial surveys. Using purposive sampling, 45 (82%) completed in-depth interviews. Fifteen obstetricians were interviewed. Participants described factors that informed their counseling (physicians) or decision-making (patients). Content analysis used an integrated approach with inductively and deductively derived codes. Patient-derived themes were stratified by treatment choice. Associations between variables and treatment choices were analyzed. RESULTS: Thirty-four women (62%) received surgical management, 19 (35%) received medical, and two (4%) received expectant. Physicians expected that women with prior pregnancies have strong management preferences, and indeed, multigravid patients were less likely to change their initial treatment choice after counseling than primigravid patients (12% compared with 42%, odds ratio [OR] 0.18, 95% confidence interval [CI] 0.04-0.81, P=.03). Physicians favored patient-centered decisions and patients chose the treatment that they thought would least affect other responsibilities. Those ultimately receiving surgical management had a higher monthly income (adjusted OR 1.30, 95% CI 1.04-1.63, P=.023) and more social support (adjusted OR 2.45, 95% CI 1.07-5.61, P=.035) than the medical group. The surgical group cited loss acceptance, a favorable perception of surgery, and a desire to expedite the miscarriage as decisive factors. The medical group endorsed control over, and timed completion of, the miscarriage in a more intimate setting, an aversion to surgery or anesthesia, and a perception of improved fertility preservation as decisive factors. Regardless of treatment choice, satisfaction with treatment was linked to a supportive clinical team and expeditious resolution. CONCLUSION: Prior pregnancy experiences, obligations, and sociodemographic factors influence miscarriage management decision-making. Structured counseling, especially for primigravid patients, could improve both the physician and the patient experience with miscarriage care.

Abnormal relaxin secretion during pregnancy in women with type 1 diabetes.

To test the hypothesis that relaxin may play a role in the fetal abnormalities associated with pregnancy in type 1 diabetic women, we previously compared gestational relaxin concentrations in diabetic and clinically normal women using a porcine relaxin radioimmunoassay (RIA): Serum immunoactive relaxin was significantly (P < 0.001) elevated in the diabetic women. To confirm and extend this work in a larger group of subjects, we have now used an enzyme-linked immunosorbent assay (ELISA) specific for human H2 relaxin (the normal human gene product) to determine immunoactive serum relaxin concentrations in serial samples from 61 Type 1 diabetic and 21 normal pregnant women. Samples from 22 of the diabetic and nine of the normal women were also directly compared in the porcine relaxin RIA. ELISA-determined serum relaxin was higher (P < 0.001) at 24 and 36 weeks of pregnancy in type 1 diabetic women than in controls, confirming previous findings. However, the geometric mean increase in immunoactive relaxin concentration in identical samples from pregnant diabetic women over that of controls was significantly greater with the RIA than with the ELISA (271% vs 44%; P < 0.001). To investigate this discrepancy, the specificity and epitope selectivity of the RIA and the ELISA were compared using several synthetic polypeptides, including human relaxins H1 and H2, and relaxin and insulin derivatives. Both assays showed great specificity, but the porcine RIA selectively identified the epitopes of the receptor-binding domain of the relaxin B chain and cross-reacted strongly with H1 and H2 relaxins. In contrast, only the H2 peptide was detected by the ELISA antiserum. Therefore, the marked discrepancy between the RIA and the ELISA could be due to the presence in the diabetic samples of another relaxin-like molecule in addition to the normal H2 relaxin. The biological consequences of elevated serum relaxin in diabetic pregnancy remain to be elucidated.

Withdrawal attitudes and experiences: a qualitative perspective among young urban adults.

CONTEXT: Withdrawal is a widely used pregnancy prevention practice, but is popularly regarded as ineffective. An in-depth study of withdrawal behaviors would improve understanding of its role in reproductive health care. METHODS: Ninety-five ethnically diverse males and females aged 18-25, recruited through family planning clinics and community outreach in a large U.S. city, participated in semistructured, open-ended interviews in 2006 and 2007. Interviews examined up to six heterosexual relationships and focused on contraceptive attitudes, norms and experiences. Transcripts were reviewed and coded, and key themes related to withdrawal were identified. RESULTS: Withdrawal was a popular contraceptive technique, but opinions on its effectiveness were mixed. Some participants (especially women) expressed anxiety concerning pregnancy risk due to perceived ineffectiveness of withdrawal, and women were concerned about their partner's capacity to consistently withdraw prior to ejaculation. Others described confidence and skill in using withdrawal, and considered it effective. Reasons for use of withdrawal included convenience and dissatisfaction with hormonal contraceptives and condoms. Withdrawal was described as an expected alternative to condoms in both casual and long-term relationships, and as a secondary, or backup, method with use of hormonal contraceptives or condoms. Participants had rarely discussed withdrawal with health care providers; knowledge about the method had generally come from less reliable sources, including peers. CONCLUSIONS: Health care provider discussions with patients about withdrawal could give greater insight into risk behaviors. More informed prevention counseling messages would be helped by better effectiveness estimates and understanding of factors most likely to result in withdrawal failure.

Young unmarried men's understanding of female hormonal contraception.

BACKGROUND: A better understanding of men's attitudes, norms and behaviors regarding women's use of hormonal contraception is needed. STUDY DESIGN: We conducted contraceptive life-history interviews with 41 ethnically diverse males ages 18-25 years which detailed up to six heterosexual relationships, focusing on knowledge, attitudes, norms and behaviors regarding hormonal contraception use, decision making and communication. RESULTS: Men's attitudes, norms and behaviors associated with hormonal contraceptive decisions and use varied greatly across participants and their relationships. Findings suggest a mixture of attitudes and practices regarding the importance of communication around contraception influenced by sexual experiences, age and relationship type. Many men demonstrated limited knowledge about contraceptives and identified improving contraceptive knowledge as an essential step in facilitating contraceptive communication. CONCLUSIONS: Increased awareness about young men's understanding of and perceived roles regarding hormonal contraception will help in designing services that address contraceptive adherence, contraceptive communication and incorrect or inadequate contraceptive knowledge.