Stephanie Q. Mistretta

Adherence and acceptability of the contraceptive ring compared with the pill among students: a randomized controlled trial.

OBJECTIVES: To compare satisfaction with and adherence to the contraceptive vaginal ring and a daily low-dose oral contraceptive pill (OCP) among college and graduate students using a novel method of electronic data collection. METHODS: We randomly assigned 273 women to the contraceptive vaginal ring (n=136) or OCP (n=137) for three consecutive menstrual cycles. Participants completed daily Internet-based, online diaries regarding method adherence and satisfaction during cycles of use. At 3 months, they completed an online survey regarding intention to continue their method and overall acceptability. At 6 months, we surveyed participants to see whether they continued using contraception and, if so, which method. RESULTS: Rates of loss to follow-up were similar between groups. Contraceptive vaginal ring users reported more perfect use in the first 2 months (P=.05). After the 3-month study period, 52 (43%) of 121 contraceptive vaginal ring users and 65 (52%) of 126 OCP users reported plans to continue their method (P=.16). However, at 6 months, only 31 (26%) of 117 contraceptive vaginal ring users and 36 (29%) of 123 OCP users had continued their assigned study method (P=.61). Almost 50% of both groups were using condoms or no method. CONCLUSION: Contraceptive vaginal ring users were more likely to report perfect use during the 3-month trial period than were OCP users. Despite randomization, participants were equally satisfied with their assigned hormonal contraceptive method. At 6 months, less than 30% of participants were still using their assigned method. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00635570. LEVEL OF EVIDENCE: I

Pharmacokinetics of the etonogestrel contraceptive implant in obese women.

OBJECTIVE We sought to examine the pharmacokinetics and acceptability of the etonogestrel contraceptive implant in obese women. STUDY DESIGN We developed and validated a plasma etonogestrel concentration assay and enrolled 13 obese (body mass index ≥30) women and 4 normal-weight (body mass index <25) women, who ensured comparability with historical controls. Etonogestrel concentrations were measured at 50-hour intervals through 300 hours postinsertion, then at 3 and 6 months to establish a pharmacokinetic curve. RESULTS All obese participants were African American, while all normal-weight participants were white. Across time, the plasma etonogestrel concentrations in obese women were lower than published values for normal-weight women and 31-63% lower than in the normal-weight study cohort, although these differences were not statistically significant. The implant device was found highly acceptable among obese women. CONCLUSION Obese women have lower plasma etonogestrel concentration than normal-weight women in the first 6 months after implant insertion. These findings should not be interpreted as decreased contraceptive effectiveness without additional considerations.

Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial ☆ ☆☆ ★

OBJECTIVE This trial was designed to compare levonorgestrel intrauterine device (LNG-IUD) use at 1 year after delivery between women randomized to postplacental insertion at the time of cesarean delivery and delayed insertion 4-8 weeks after delivery. STUDY DESIGN This randomized controlled trial was conducted at two urban medical centers. Eligible pregnant women with planned cesarean deliveries were randomized to immediate postplacental insertion during cesarean or delayed insertion after 4-8 weeks. We used intention-to-treat analysis for the primary outcome of LNG-IUD use 12 months after delivery. RESULTS Forty-two women were randomized, 20 into the postplacental group and 22 in the delayed group. Although confirmed use of the LNG-IUD 12 months after delivery was higher in the postplacental group (60.0% vs. 40.9%, p=.35), this difference was not statistically significance. Expulsion was significantly more common in the postplacental group (20.0% vs. 0%, p=.04). There were significant differences between the two sites in baseline population characteristics, follow-up and expulsion. The trial did not answer the intended question as it was halted early due to slow enrollment. CONCLUSIONS Our results show higher expulsion after postplacental insertion compared to delayed insertion but suggest similar IUD use at 12 months. Moreover, it provides valuable lessons regarding a randomized controlled trial of postplacental LNG-IUD placement due to the challenges of estimating effect size and the nature of the population who might benefit from immediate insertion. IMPLICATIONS Postplacental insertion of an IUD may improve use of highly effective contraception during the postpartum period. While our results suggest higher expulsion after postplacental insertion compared to delayed insertion and similar IUD use at 12 months, our trial was insufficient to definitively test our hypothesis.

Daily context matters: predictors of missed oral contraceptive pills among college and graduate students

OBJECTIVE The purpose of this study was to understand the relationship between daily contextual factors and oral contraceptive (OC) adherence among students who attend college or graduate school. STUDY DESIGN Data on OC adherence, demographics, contextual factors, and side-effects were collected as part of the acceptability of the NuvaRing (Merck & Co, Whitehouse Station, NJ) vs OC study, in which students were assigned randomly to the contraceptive vaginal ring or to a low-dose OC. We performed bivariate and multivariable analyses to create an explanatory model for nonperfect OC adherence (missed at least 1 pill during 3 months of use). RESULTS In a multivariable predictive model, missing a pill was associated positively with high perceived stress (odds ratio [OR], 3.16; P = .007), having ≥10 hours per week of paid employment (OR, 2.13; P = .075), and living with a partner (OR, 9.92; P = .040). CONCLUSION Stressful and hectic lives contribute to poor OC adherence. When counseling women about contraception, clinicians should consider the influence of daily life on contraceptive adherence.

Doula support during first-trimester surgical abortion: a randomized controlled trial

OBJECTIVE The objective of the study was to evaluate the impact of doula support on first-trimester abortion care. STUDY DESIGN Women were randomized to receive doula support or routine care during first-trimester surgical abortion. We examined the effect of doula support on pain during abortion using a 100 mm visual analog scale. The study had the statistical power to detect a 20% difference in mean pain scores. Secondary measures included satisfaction, procedure duration, and patient recommendations regarding doula support. RESULTS Two hundred fourteen women completed the study: 106 received doula support, and 108 received routine care. The groups did not differ regarding demographics, gestational age, or medical history. Pain scores in the doula and control groups did not differ at speculum insertion (38.6 [±26.3 mm] vs 43.6 mm [±25.9 mm], P = .18) or procedure completion (68.2 [±28.0 mm] vs 70.6 mm [±23.5 mm], P = .52). Procedure duration (3.39 [±2.83 min] vs 3.18 min [±2.36 min], P = .55) and patient satisfaction (75.2 [±28.6 mm] vs 74.6 mm [±27.4 mm], P = .89) did not differ between the doula and control groups. Among women who received doula support, 96.2% recommended routine doula support for abortion and 60.4% indicated interest in training as doulas. Among women who did not receive doula support, 71.6% of women would have wanted it. Additional clinical staff was needed to provide support for 2.9% of women in the doula group and 14.7% of controls (P < .01). CONCLUSION Although doula support did not have a measurable effect on pain or satisfaction, women overwhelmingly recommended it for routine care. Women receiving doula support were less likely to require additional clinic support resources. Doula support therefore may address patient psychosocial needs.

A motivational interviewing-based counseling intervention to increase postabortion uptake of contraception: A pilot randomized controlled trial

OBJECTIVE To determine if a counseling intervention using the principles of motivational interviewing (MI) would impact uptake of long-acting reversible contraception (LARC) after abortion. METHODS We conducted a pilot randomized controlled trial comparing an MI-based contraception counseling intervention to only non-standardized counseling. Sixty women 15-29 years-old were randomized. PRIMARY OUTCOME uptake of LARC within four weeks of abortion. SECONDARY OUTCOMES uptake of any effective contraceptive, contraceptive use three months after abortion and satisfaction with counseling. Bivariate analysis was used to compare outcomes. RESULTS In the intervention arm, 65.5% of participants received a long-acting method within four weeks compared to 32.3% in the control arm (p=0.01). Three months after the abortion, differences in LARC use endured (60.0% vs. 30.8%, p=0.05). Uptake and use of any effective method were not statistically different. More women in the intervention arm reported satisfaction with their counseling than women in the control arm (92.0% vs. 65.4%, p=0.04). CONCLUSION Twice as many women in the MI-based contraception counseling intervention initiated and continued to use LARC compared to women who received only non-standardized counseling. PRACTICE IMPLICATIONS A contraception counseling session using the principles and skills of motivational interviewing has the potential to impact LARC use after abortion.

Impact of a revised appointment scheduling script on IUD service delivery in three Title X family planning clinics.

OBJECTIVE The objective was to study a redesigned call script for intrauterine device (IUD) appointment scheduling. STUDY DESIGN The script for a Title X call center was redesigned. Pre- and postintervention data were collected. RESULTS For women with a scheduled IUD visit (n=99, pre n=57, post n=42), the preintervention IUD insertion rate was 47%; the postintervention insertion rate was 60% (p=.23). Among women ≤25 years old, the preintervention rate was 41% and the postintervention rate was 68% (p=.05). No-show rates decreased (40.4% vs. 23.8%, p=.08), particularly for younger women (n=51; 46.9% vs. 15.8%, p=.04). CONCLUSION A revised IUD appointment scheduling script improved long-acting reversible contraceptive uptake. IMPLICATIONS Revising an appointment scheduling call script is a simple and scalable intervention to decrease administrative and clinical barriers to family planning services. As many clinics in the United States move toward computerized and centralized call centers, improving patient communication during the scheduling process may have a broad impact on clinical efficiency.