Gretchen S. Stuart

Initiation of oral contraceptives using a quick start compared with a conventional start: a randomized controlled trial.

OBJECTIVE: To estimate whether young women taking the first pill on the day of prescription had higher continuation rates and lower pregnancy rates than women who waited until menses to start the oral contraceptive pill (OCP). METHODS: We recruited 1,716 women aged younger than 25 years seeking to initiate the oral contraceptive at three publicly funded family planning clinics, and randomly assigned them to conventional initiation of the pill (conventional start) or immediate, directly observed ingestion of the first pill (quick start) during the clinic visit. Women underwent follow-up interviews at 3 and 6 months. RESULTS: Sixty percent of participants discontinued the pill, and 8% became pregnant during follow-up. Women who took the first pill in the clinic were more likely to continue to the second OCP pack (odds ratio 1.5, 95% confidence interval 1.0–2.1.); however, the Quick Start approach did not improve OCP continuation rates at 3 and 6 months. Those assigned to Quick Start were slightly less likely to become pregnant within 6 months from the time they started the pill (hazard ratio 0.90, 95% confidence interval 0.64—1.25). Eighty-one percent of women rated the Quick Start approach as acceptable or preferable to waiting. Rates of serious adverse events were low and similar in the two groups. CONCLUSION: Protocols that require a woman to wait until the next menses to start hormonal contraceptives are an obstacle to contraceptive initiation. Directly observed, immediate initiation of the pill improves short-term continuation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00068848 LEVEL OF EVIDENCE: I

Social desirability bias in family planning studies: a neglected problem

Studies on family planning methods traditionally have relied on self-reports of unknown validity and reproducibility. Social desirability bias, a type of information bias, occurs when study participants respond inaccurately - but in ways that will be viewed favorably by others. Several lines of evidence reveal that this bias can be powerful in sexual matters, including reports of coitus, use of contraceptives and induced abortion. For example, studies using vaginal prostate-specific antigen testing reveal underreporting of unprotected coitus and overreporting of barrier contraceptive use. Medication Event Monitoring System studies, which electronically record the time of pill dispensing from a bottle or pack, indicate widespread exaggeration of adherence to pill-taking regimens, including oral contraceptives. Comparisons of provider data and self-reports of induced abortions reveal extensive underreporting of induced abortion. Reliance on self-reported data underestimates contraceptive efficacy. Although techniques to minimize this bias exist, they are infrequently used in family planning studies. Greater skepticism about self-reports and more objective means of documenting coitus and contraceptive use are needed if contraceptive efficacy is to be accurately measured.

Second-Trimester Abortion for Fetal Anomalies or Fetal Death: Labor Induction Compared With Dilation and Evacuation

OBJECTIVE: To compare the safety and effectiveness of dilation and evacuation (D&E) and labor-induction abortion performed for fetal anomalies or fetal death in the second trimester. METHODS: We performed a retrospective cohort study of second-trimester abortions performed for fetal indications. We compared the frequency of complications and effectiveness of abortions performed at 13–24 weeks for these indications. We calculated proportions of patients with complications for these two methods and controlled for confounding using a log binomial model. RESULTS: Labor-induction abortions had higher complication rates and lower effectiveness than did D&E. Thirty-two of 136 women undergoing labor induction (24%) experienced one or more complications, in contrast to 9 of 263 women (3%) undergoing D&E (unadjusted relative risk 6.9 [95% confidence interval 3.4–14.0]). When controlled for confounding, the adjusted risk ratio for labor induction was 8.5 (95% confidence interval 3.7–19.8) compared with D&E. CONCLUSION: Dilation and evacuation is significantly safer and more effective than labor induction for second-trimester abortion for fetal indications. Bias and chance are unlikely explanations for these large discrepancies. Women facing this difficult decision should be offered a choice of methods and be provided information about their comparative safety and effectiveness. LEVEL OF EVIDENCE: II

Characteristics associated with interest in long-acting reversible contraception in a postpartum population.

BACKGROUND Short interpregnancy intervals lead to adverse perinatal outcomes and could be prevented with increased use of long-acting reversible contraception (LARC) in the postpartum period. The primary objective of this study was to assess which baseline characteristics are associated with the intent to use LARC among postpartum women. STUDY DESIGN This study was a substudy of baseline data from a randomized controlled trial. Eight hundred women completed a pre-intervention survey of demographics and reproductive health history and intentions. We estimated adjusted relative risks (RRs) of intent to use LARC for baseline characteristics of interest. RESULTS Three hundred three postpartum women (38%) intended to use LARC. Two out of 10 baseline characteristics were significantly associated with intent to use LARC: not trying for pregnancy at time of conception [adjusted RR, 1.6; 95% confidence interval (CI), 1.2-2.1] and no desire for another pregnancy within 2 years (adjusted RR, 1.9; 95% CI, 1.2-2.8). CONCLUSIONS High interest in LARC exists among postpartum women, particularly among women with a recent unintended pregnancy and women who do not desire pregnancy for at least 2 years. Past and future pregnancy intentions should be incorporated into future models and frameworks that evaluate postpartum contraceptive choice. Educational intervention studies are also needed to assess if LARC interest can be increased among postpartum women who are less likely to intend to use LARC but at risk for future adverse perinatal outcomes.

Combined oral contraceptives and antiretroviral PK/PD in Malawian women: pharmacokinetics and pharmacodynamics of a combined oral contraceptive and a generic combined formulation antiretroviral in Malawi.

This letter to the editor addresses the concern regarding women who are HIV positive and interested in oral contraceptives. HIV positive women are typically advised to avoid using combined oral contraceptives which proves difficult because COC’s are the most widely circulated contraceptives in the world. Health care professionals must understand the pharmacokinetics and pharmacodynamics between COC pills and ART treatments. This is especially important in areas with high rates of HIV positive women or where rates exceed 10% HIV positive females within the HIV population. In these areas women should be informed of the most effective treatment for their unique condition.

Barriers to Receiving Long-acting Reversible Contraception in the Postpartum Period.

OBJECTIVE To assess why postpartum women who desired long-acting reversible contraception (LARC) did not receive it in the postpartum period and to assess which contraceptive methods they were using instead. STUDY DESIGN This was a subgroup analysis of 324 women enrolled in a randomized, controlled trial to receive or not receive an educational LARC script during their postpartum hospitalization. Participants in this subgroup analysis stated that they were either using LARC (n = 114) or interested in using LARC (n = 210) during a follow-up survey completed after their scheduled 6-week postpartum visit. Modified Poisson regression analysis was used to assess for characteristics associated with using LARC by the time of the follow-up survey. RESULTS Women who were interested in LARC but not using it were more likely to be multiparous (relative risk [RR], 1.59; 95% CI, 1.19-2.11) and to have missed their postpartum visit (RR, 25.88; 95% CI, 3.75-178.44) compared with those using LARC. Among the interested 210 who were not using LARC, the most common reasons provided for non-use were that they were told to come back for another insertion visit (45%), missed the postpartum visit (26%), and could not afford LARC (11%). The most common contraceptive methods used instead of LARC were barrier methods (42%) and abstinence (19%); 18% used no contraceptive method. CONCLUSION Two-thirds (65%) of postpartum women who desired to use LARC did not receive it in the postpartum period and used less effective contraceptive methods. Increasing access to immediate postpartum LARC and eliminating two-visit protocols for LARC insertion may increase postpartum LARC use. As the Affordable Care Act moves toward full implementation, it is necessary to understand the barriers that prevent interested patients from receiving LARC.

Intrauterine Device Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial.

OBJECTIVE: To compare intrauterine device (IUD) use at 6 months postpartum among women who underwent intracesarean delivery (during cesarean delivery) IUD placement compared with women who planned for interval IUD placement 6 or more weeks postpartum. METHODS: In this nonblinded randomized trial, women who were undergoing a cesarean delivery and desired an IUD were randomized to intracesarean delivery or interval IUD placement. The primary outcome was IUD use at 6 months postpartum. A sample size of 112 (56 in each group) was planned to detect a 15% difference in IUD use at 6 months postpartum between groups. RESULTS: From March 2012 to June 2014, 172 women were screened and 112 women were randomized into the trial. Baseline characteristics were similar between groups. Data regarding IUD use at 6 months postpartum were available for 98 women, 48 and 50 women in the intracesarean delivery and interval groups, respectively. A larger proportion of the women in the intracesarean delivery group were using an IUD at 6 months postpartum (40/48 [83%]) compared with those in the interval group (32/50 [64%], relative risk 1.3, 95% confidence interval 1.02–1.66). Among the 56 women randomized to interval IUD insertion, 22 (39%) of them never received an IUD; 14 (25%) never returned for IUD placement, five (9%) women declined an IUD, and three (5%) had a failed IUD placement. CONCLUSION: Intrauterine device placement at the time of cesarean delivery leads to a higher proportion of IUD use at 6 months postpartum when compared with interval IUD placement. LEVEL OF EVIDENCE: I

Coitus Interruptus Is Not Contraception

This letter to the editor argues against an article suggesting that coitus interruptus should be acknowledged as a preventer of pregnancy. It asserts that coitus interruptus should never be presented to adolescents or anyone as a valid method of contraception because adolescents experience elevated rates of sexually transmitted infections and unintended pregnancy.

Screening women for oral contraception: can family history identify inherited thrombophilias?

OBJECTIVE: Screening for inherited thrombophilias with laboratory tests is impractical before starting women on combined oral contraceptives. As an alternative, some recommend eliciting a family history of venous thromboembolism. The validity of this approach, however, remains unclear. DATA SOURCES: We sought all published reports that correlated a family history of venous thromboembolism with any thrombophilia confirmed by laboratory test. We used sequential, overlapping computer searches including MeSH terms used for articles in PubMed, a narrative search phrase in Google Scholar, and then all “related” articles in PubMed for each article included without time or language limitations. This was supplemented by a search of www.clinicaltrials.gov. METHODS OF STUDY SELECTION: The search yielded 10 reports. Information was sought without success from corresponding authors of four other reports that may have had relevant data. Most reports studied atypical, high-prevalence referral populations. TABULATION, INTEGRATION, AND RESULTS: Results were presented according to the MOOSE (Meta-analysis of observational studies in epidemiology) guidelines for systematic reviews of observational studies. The patient populations varied widely, definitions of family history included first- or first- and second-degree relatives, and the thrombophilias studied differed among these reports. Hence, aggregation of results was not possible. Despite these differences, all reports consistently documented poor validity of family history for detecting thrombophilias. Sensitivity ranged from 16% to 63% and positive predictive value from 6% to 50% for the various thrombophilias studied. In no study did family history meet the benchmark for a good test (sensitivity plus specificity greater than 150%). CONCLUSION: Obtaining a family history of venous thromboembolism before starting combined oral contraceptives is not a valid means to detect a womans risk of thrombophilia. Even in high-prevalence populations, in which the positive predictive value is increased, a positive family history of venous thromboembolism was no better than flipping a coin in predicting thrombophilia.

Fourteen million women with limited options: HIV/AIDS and highly effective reversible contraception in sub-Saharan Africa.

An estimated 14 million women in sub-Saharan Africa are HIV infected and these women deserve access to evidence-based family planning services. Increasing contraceptive use in HIV-infected women can reduce the numbers of unintended pregnancies and thus reduce maternal death and vertical transmission of HIV. A delicate balance exists between risks associated with pregnancy and any theoretical risks of acquiring, transmitting or worsening HIV attributable to using a contraceptive. This commentary reviews interactions between hormonal, intrauterine and barrier contraception in HIV-infected women, with a focus on sub-Saharan Africa. Unfortunately, the evidence on these interactions to guide family planning providers is limited and more research in this area is urgently needed.