Carolyn L. Westhoff

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

Pharmacokinetics of a combined oral contraceptive in obese and normal-weight women

BACKGROUND This study was conducted to compare oral contraceptive (OC) pharmacokinetics (PK) in normal-weight [body mass index (BMI) 19.0-24.9] and obese (BMI 30.0-39.9) women. STUDY DESIGN During the third week of the third cycle of OC use, we admitted 15 normal-weight and 15 obese women for collection of 12 venous specimens over 24 h. Using radioimmunoassay techniques, we measured levels of ethinyl estradiol (EE) and levonorgestrel (LNG). During the same cycle, women underwent twice-weekly sonography to assess ovarian follicular development and blood draws to measure endogenous estradiol (E2) and progesterone levels. RESULTS Obese women had a lower area under the curve (AUC; 1077.2 vs. 1413.7 pg*h/mL) and lower maximum values (85.7 vs. 129.5 pg/mL) for EE than normal-weight women (p=.04 and <0.01, respectively); EE trough levels were similar between BMI groups. The similar, but smaller, differences in their LNG levels for AUC and maximum values (C(max)) were not statistically significant. While peak values differed somewhat, the LNG trough levels were similar for obese and normal-weight women (2.6 and 2.5 ng/mL, respectively). Women with greater EE AUC had smaller follicular diameters (p=.05) and lower E2 levels (p=.04). While follicular diameters tended to be larger among obese women, these differences were not statistically significant. CONCLUSION OC hormone peak levels are lower among obese women compared to normal-weight women, but their trough levels are similar. In this small study, the observed PK differences did not translate into more ovarian follicular activity among obese OC users.

Tubal sterilization trends in the United States

OBJECTIVE To review the rate, setting, and demographic characteristics of tubal sterilization and its current trend within contraceptive practice in the United States. DESIGN Review of U.S. health care statistics, NCHS publications, English-language literature searched using MEDLINE and PubMed, and bibliographies of key references. RESULT(S) Total annual cases of tubal sterilization have declined from 687,000 in 1995 to 643,000 in 2006, despite a 4% population growth. Interval sterilizations decreased by 12%. Postpartum sterilizations remained stable and follow 8%-9% of all live births. Tubal sterilizations remain more common in black and Hispanic women; women with lower income, lower education, and higher parity; and among women living in the South. From 1981 to 1995, inpatient interval sterilizations fully migrated to ambulatory surgery care. CONCLUSION(S) After two decades of stable rates, there is a recent decline in sterilization. Improved access to a wide range of highly effective reversible contraceptives gives women flexibility when deciding how to manage their reproductive ability.

Immediate postabortion access to IUDs, implants and DMPA reduces repeat pregnancy within 1 year in a New York City practice

OBJECTIVE The objective was to evaluate whether having intrauterine devices (IUDs), contraceptive implants and injections immediately available to women undergoing abortion, compared to requiring an additional visit for these methods, leads to fewer pregnancies and fewer abortions in the following 12 months. METHODS We conducted a historical cohort study using health records of Medicaid-insured women obtaining a first-trimester surgical abortion within a single practice in New York City. Women in Cohort 1 (2007-2008) needed an additional visit to initiate the IUD or injection. Women in Cohort 2 (2008-2009) were able to initiate these contraceptives and implants during the abortion visit. Women in both cohorts received these methods without additional cost, and all could receive a pill, patch or ring prescription. We compared the proportions of each cohort who experienced a pregnancy that began in the 12 months following the index abortion and also evaluated the outcomes of those pregnancies. RESULTS Cohorts 1 and 2 consisted of 407 and 405 women, respectively. The proportions with pregnancy beginning over the following 12 months were substantially greater in Cohort 1 than Cohort 2 (27.3% versus 15.3%, p<.001). Women in Cohort 1 then underwent both more additional abortions (17.2% versus 9.9%, p=.003) and more births (7.9% versus 3.7%, p=.02). The proportion of women in Cohort 1 who initiated IUDs and implants within 12 months was smaller than in Cohort 2 (11% versus 46%, p<.001). CONCLUSIONS Among women insured by Medicaid, offering immediate comprehensive contraceptive access--including IUDs and implants--on the same day as an induced abortion, compared to requiring an additional visit, increased uptake of IUDs and implants and decreased repeat pregnancies in the next 12 months and abortions.

Predictors of noncompliance in an oral contraceptive clinical trial.

BACKGROUND This analysis was conducted to identify the participant characteristics associated with noncompliance in an oral contraceptive (OC) clinical trial. STUDY DESIGN We studied ovarian suppression among normal-weight and obese women during the use of levonorgestrel (LNG)-containing combination OCs. Participants underwent twice weekly phlebotomy during the study cycle and received up to

Structured contraceptive counseling—A randomized controlled trial

360 for participation. Along with other study assays, we analyzed 903 specimens from 181 women to measure LNG to assess OC compliance. Consistently undetectable LNG levels indicated noncompliance. To evaluate predictors of OC noncompliance during this study, we compared the characteristics of compliant and noncompliant participants using multivariable logistic regression. We assigned each participant to a relative poverty level based on US census data; all other individual characteristics came directly from participant responses during the baseline interview. RESULTS One hundred eighty-one women completed the study; 31 were noncompliant (17%). In multivariable analyses, poverty level was the strongest predictor of noncompliance. Compared with those women in the quartile with the lowest level of residential poverty, other women were far more likely to be noncompliant, especially women in the quartile with the greatest prevalence of poverty (adjusted odds ratio, 8.4; 95% confidence interval, 1.5-46.1). Additional factors associated with noncompliance were education level less than a bachelors degree and Hispanic ethnicity. Other demographic and psychometric measures were not associated with compliance. CONCLUSIONS We found that noncompliance was strongly associated with residential poverty level, an indirect measure of individual income. In the United States, poverty is associated with female obesity, Hispanic ethnicity and low education, which were also associated here with noncompliance. Study compensation may motivate poor individuals to participate in clinical trials for income. Noncompliance in clinical trials, particularly differential noncompliance, jeopardizes study validity.

Carbamazepine coadministration with an oral contraceptive: Effects on steroid pharmacokinetics, ovulation, and bleeding

OBJECTIVE To evaluate the addition of structured contraceptive counseling to usual care on choice, initiation, and continuation of very effective contraception after uterine aspiration. METHODS We conducted a RCT of a version of the WHO Decision-Making Tool for Family Planning Clients and Providers with women having a procedure for a spontaneous or induced abortion. Our intervention provided structured, standardized counseling. We randomized women to usual care or usual care with structured counseling. Our outcomes included choosing a very effective contraceptive method and 3 months continuation. RESULTS Fifty-four percent of all participants chose a very effective method. Women in the intervention group were no more likely to choose a very effective method (OR 0.74, 95% CI 0.44, 1.26) or to initiate their method compared to the usual care group (OR 0.65, 95% CI 0.31, 1.34). In multivariate models, structured counseling was not associated with using a very effective method at 3 months (AOR 1.06, 95% CI 0.53, 2.14). CONCLUSION In this setting, structured counseling had little impact on contraceptive method choice, initiation, or continuation. PRACTICE IMPLICATIONS Adding structured counseling did not increase the proportion choosing or initiating very effective contraception in a practice setting where physicians already provide individualized counseling.

Medical abortion practices: a survey of National Abortion Federation members in the United States

Purpose:  Antiepileptic drugs (AEDs) are widely used in reproductive‐age women. The AED carbamazepine (CBZ) induces the hepatic cytochrome P450 system, thereby accelerating hormone metabolism. We sought to assess the pharmacodynamic effects of CBZ on breakthrough bleeding and ovulation during oral contraceptive (OC) use.

Body weight does not impact pregnancy rates during use of a low-dose extended-regimen 91-day oral contraceptive

BACKGROUND Little is known about clinical implementation of medical abortion in the United States following approval of mifepristone as an abortifacient by the Food and Drug Administration (FDA) in 2000. We collected information regarding medical abortion practices of National Abortion Federation (NAF) members for the year 2001. METHODS Questionnaires were mailed to 337 active US NAF member facilities. RESULTS A total of 258 facilities responded (77%); 252 nonhospital facilities were included in the analysis. Most of these facilities (87%) offered medical abortion in 2001, providing an estimated 28,400 medical abortions, approximately 52% of medical abortions in the US that year. Over 75% began offering mifepristone/misoprostol abortions within 5 months of the start of mifepristone distribution. Almost all (99%) reported using mifepristone/misoprostol regimens, with most offering one or more evidence-based alternative regimens (83%); a few (4%) used the FDA-approved regimen. CONCLUSION After FDA approval of mifepristone, NAF member facilities rapidly adopted evidence-based mifepristone/misoprostol regimens.

Music as an auxiliary analgesic during first trimester surgical abortion: a randomized controlled trial

BACKGROUND This study evaluated the impact of weight on efficacy during use of an extended oral contraceptive (OC). STUDY DESIGN Data were from a Phase 3 clinical trial evaluating the efficacy of a low-dose 91-day extended regimen of 100 mcg levonorgestrel/20 mcg ethinyl estradiol (LNG/EE; 84 days)+10 mcg EE (7 days) for the prevention of pregnancy. Crude pregnancy rates were calculated for weight and body mass index (BMI) deciles. RESULTS Of the 1736 women in this analysis, 878 (50.6%) had a BMI greater than 25 kg/m2, and 770 (44.4%) were heavier than 70 kg. Pregnancies occurred in 36 women. Crude pregnancy rates were similar across weight and BMI deciles, with no discernable differences observed between deciles using either classification criterion. CONCLUSIONS No evidence of any reduction in the level of contraceptive efficacy was observed with this low-dose extended OC regimen in overweight and obese women.