Alisa B. Goldberg

Using Daily Text-Message Reminders to Improve Adherence With Oral Contraceptives: A Randomized Controlled Trial

OBJECTIVE: To estimate whether women receiving daily text-message reminders have increased oral contraceptive pill adherence compared with women not receiving reminders. METHODS: This randomized controlled trial estimated whether there was an effect of daily text-message reminders on oral contraceptive pill adherence of new oral contraceptive pill users. Pill-taking was tracked for 3 months by an electronic monitoring device with wireless data collection. During the study period, participants assigned the intervention received a daily reminder text message. Eighty-two women were assigned randomly to detect a 1.6±2.0 pill difference (90% power, 5% &agr;, 15% dropout). RESULTS: Participants were 79% white, non-Hispanic, 99% high school graduates, and 99% nulliparous with a mean age of 22 years. Most reported condom use with past coital activity, and more than half reported prior emergency contraception use. The mean number of missed pills per cycle did not differ significantly between the groups: 4.9±3.0 for the text-message group and 4.6±3.5 for the control group (P=.60). The number of missed pills per cycle increased over the course of the study, but this pattern did not increase differentially between the groups. Adherence recorded by the electronic monitoring device indicated much poorer adherence than that recorded by patient diaries. Despite poor pill-taking, there were no pregnancies. CONCLUSION: Daily text-message reminders did not improve oral contraceptive pill adherence. Although the lack of benefit may be attributed to the frequent use of alternative reminder systems in the control group, the rate of missed pills when measured objectively was still very high in both groups. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00733707. LEVEL OF EVIDENCE: I

Misoprostol administered by epithelial routes: Drug absorption and uterine response.

OBJECTIVE: To quantify and compare serum levels and uterine effects following vaginal (dry), vaginal (moistened), buccal, and rectal misoprostol administration. METHODS: Forty women seeking elective abortion between 6 and 12 6/7 weeks were randomly assigned to receive 400 μg of misoprostol by one of four routes. A 2.5-mm pressure monitoring catheter was placed through the cervix to the uterine fundus to record uterine tone and activity during the 5-hour observation period. Serum levels of misoprostol acid were measured at 15 and 30 minutes, then every 30 minutes. RESULTS: The four groups were similar in age, race or ethnicity, body mass index, parity, and gestation. Serum levels after vaginal, vaginal moistened and buccal administration rose gradually, peaked between 15 and 120 minutes and fell slowly. Vaginal and vaginal moistened routes produced higher peak serum levels than buccal and rectal (445.9 and 427.1 compared with 264.8 and 202.2 pg/mL; P=.03) and higher serum concentration area under the curve at 5 hours (1,025.0 and 1279.4 compared with 519.6 and 312.5 pg-hr/mL; P<.001). Uterine tone and activity, however, were similar for buccal and the two vaginal routes. After rectal administration, serum levels peaked earlier (P<.001) then dropped more abruptly, and peak uterine tone (P<.001) and total activity (P=.04) were lower than after the other routes. CONCLUSION: Although serum levels were lower for buccal compared with the vaginal routes, the three routes produced similar uterine tone and activity. Rectal administration produced lower uterine tone and activity. Vaginal serum levels were two to three and a half times higher than those observed in prior misoprostol pharmacokinetic studies. LEVEL OF EVIDENCE: II-1

Manual Versus Electric Vacuum Aspiration for Early First-Trimester Abortion: A Controlled Study of Complication Rates

OBJECTIVE: Manual vacuum aspiration is an alternative to electric suction curettage for first-trimester elective abortion. Although many studies have demonstrated that manual vacuum aspiration is safer than sharp curettage for abortion, only a few studies have directly compared it with electric suction curettage. These studies proved the methods to be equally effective and acceptable but were too small to adequately compare safety. We compared immediate complication rates for abortions performed by manual and electric vacuum aspiration. METHODS: We conducted a retrospective cohort analysis of all women undergoing elective abortion at up to 10 weeks’ gestation at San Francisco General Hospital over a 3.5-year period. A total of 1726 procedures were included: 1002 manual and 724 electric vacuum aspirations. Clinical data were collected from medical records. Rates of uterine reaspiration and other immediate complications occurring at our institution were compared. RESULTS: We found no difference in the rate of uterine reaspiration after abortions performed with the manual or electric suction device (2.2% versus 1.7%, respectively, P = .43). We had 80% statistical power to detect a 2% difference in uterine reaspiration rates with an μa error of .05. Overall major complication rates were 2.5% with manual and 2.1% with electric suction curettage, P = .56. Multivariable regression analyses controlling for potential confounders showed no difference in uterine reaspiration rates (electric odds ratio [OR] = 0.71, 95% confidence interval [CI] 0.32, 1.6) or overall complications (electric OR = 0.81, 95% CI 0.40, 1.7). CONCLUSION: Manual vacuum aspiration is as safe as electric suction curettage for abortions at up to 10 weeks’ gestation. Expanded use in an office setting might increase abortion access. LEVEL OF EVIDENCE: II-2

Expanding access to intrauterine contraception

The intrauterine device is a safe, highly effective, long-lasting, yet reversible method of contraception. Expanding access to intrauterine contraception is an important measure to reduce the rate of unintended pregnancy in the United States. Clinicians should consider intrauterine contraception in appropriate candidates, including women who are nulliparous, adolescent, immediately postpartum or postabortal, and desiring emergency contraception, and as an alternative to permanent sterilization. Barriers to intrauterine contraception such as requiring cervical cancer screening before insertion, routine testing for gonorrhea and chlamydial infection in low-risk women, or scheduling insertion only during menses are unnecessary.

Emergency contraception: a clinical review.

Emergency contraception is defined as a drug or device used to prevent pregnancy after unprotected sexual intercourse (including sexual assault) or after a recognized contraceptive failure. In the United States, 1.5 mg of levonorgestrel, packaged as Plan B, and the Copper T 380A intrauterine device are the most common emergency contraceptives available to women and are effective up to 5 days after unprotected sexual intercourse. In August 2006, Plan B was approved for over-the-counter sale to women aged 18 and older in the United States. It is not yet known whether the increased availability of emergency contraception will decrease unintended pregnancy and induced abortion rates.

Male Perpetration of Intimate Partner Violence and Involvement in Abortions and Abortion-Related Conflict

Men aged 18 to 35 years (n = 1318) completed assessments of perpetration of intimate partner violence (IPV), abortion involvement, and conflict regarding decisions to seek abortion. IPV was associated with greater involvement by men in pregnancies ending in abortion and greater conflict regarding decisions to seek abortion. IPV should be considered within family planning and abortion services; policies requiring women to notify or obtain consent of partners before seeking an abortion should be reconsidered; they may facilitate endangerment and coercion regarding such decisions.

Post-abortion depot medroxyprogesterone acetate continuation rates: a randomized trial of cyclic estradiol

Irregular menstrual bleeding is a common reason for discontinuation of depot medroyprogesterone acetate (DMPA) contraception. We conducted a double-blind, randomized placebo controlled trial to estimate if transdermal estradiol used in a cyclic fashion could make DMPA bleeding patterns more acceptable and improve DMPA continuation rates. Women initiating DMPA contraception immediately post-abortion (N = 132) were randomized to receive either a low sustained dose of transdermal 17-beta estradiol (0.10 mg/day, Climara) or an identical placebo to be used in a cyclic manner for 3 months. Bleeding patterns, contraceptive use, and pregnancy rates were measured for 1 year after enrollment. Cyclic transdermal estrogen did not create regular bleeding patterns in new users of DMPA and had no effect on DMPA continuation rates (relative hazard = 0.93, 95%CI 0.65-1.33). By 12 months after enrollment, 19.4% of those randomized to estrogen and 23.9% of those randomized to placebo were still using DMPA for contraception. There was no difference in the frequency of DMPA discontinuation primarily for abnormal uterine bleeding between groups (relative risk ratio = 0.95, 95%CI 0.40-2.23). Few women who discontinued DMPA switched to highly effective methods of contraception and within 1 year of an abortion, there were 18 repeat pregnancies (21.9%). Compliance with the estrogen patches was poor resulting in early study termination and inadequate statistical power to detect a clinically significant difference in DMPA continuation rates. Continuation rates of DMPA were low and repeat pregnancy rates were high among women initiating DMPA at the time of abortion. Cyclic transdermal estradiol use is an unacceptable regimen for preventing the irregular bleeding associated with DMPA initiation.

Malpositioned Intrauterine Contraceptive Devices: Risk Factors, Outcomes, and Future Pregnancies

OBJECTIVE: To assess possible risk factors, management, and outcomes for women with malpositioned intrauterine contraception devices (IUDs). METHODS: This retrospective case–control study compared 182 women with malpositioned IUDs shown by ultrasonography at a single institution from 2003 to 2008 with 182 women with properly positioned IUDs. We evaluated whether insertion at 6–9 weeks postpartum, postabortion placement, breastfeeding, type of IUD, pregnancy history, leiomyomas, suspected adenomyosis, and indication for placement were associated with malpositioning. Our study had 70–99% power to detect whether postpartum placement was associated with an odds ratio (OR) of 2–3. RESULTS: Malpositioned devices were noted on 10.4% of ultrasonography scans among women with IUDs having pelvic ultrasonography for any indication. Most malpositioned devices (73.1%) were noted to be in the lower uterine segment or cervix. Insertion of IUDs at 6–9 weeks postpartum was not associated with malpositioning (OR 1.46, 95% confidence interval [CI] 0.81–2.63). Among other possible risk factors examined, suspected adenomyosis was associated with IUD malpositioning (OR 3.04, 95% CI 1.08–8.52), whereas prior vaginal delivery (OR 0.53 95% CI 0.32–0.87) and private insurance (OR 0.38, 95% CI 0.24–0.59) were protective. Approximately two-thirds (66.5%) of malpositioned devices were removed by health care providers. There were more pregnancies within 2 years among those in the case group than those in the control group (19.2% compared with 10.5%, P=.046). All pregnancies were the result of IUD expulsion or removal, and none occurred with a malpositioned IUD known to be in situ. CONCLUSION: Malpositioning of IUDs does not appear to be associated with insertion at 6–9 weeks postpartum. Women with malpositioned IUDs are more likely to become pregnant because of IUD removal without initiation of another highly effective contraceptive method. LEVEL OF EVIDENCE: II

Acceptability of manual versus electric aspiration for first trimester abortion: a randomized trial.

This study was conducted to compare the acceptability of manual and electric vacuum aspiration for first trimester elective abortion. Eighty-four women seeking abortions at less than 10 weeks gestation were randomized to abortion by manual or electric vacuum aspiration. Post-procedure questionnaires were administered to patients to assess pain, noise disturbance and overall satisfaction with the abortion procedure. Physicians reported procedural difficulty, their perceptions of patient discomfort and their overall acceptance of the procedure. Other outcomes included amounts of anesthesia required and complication rates. There were no significant differences in pain levels or satisfaction reported by patients; however, significantly more women in the electric group were bothered by noise (19% vs. 2%, p = 0.03). There were no differences in physician assessments of procedural difficulty; however, there were significantly more times in the electric group that physicians would have preferred manual aspiration (43% vs. 17%, p = 0.02). There were four crossovers from manual to electric, and none from electric to manual. It is concluded that physicians and patients find manual vacuum aspiration as acceptable as electric vacuum aspiration for elective abortions performed at less than 10 weeks gestation.

Induction of labor: the misoprostol controversy

Misoprostol (Cytotec) is safe and effective for induction of labor, although it is not approved by the Food and Drug Administration (FDA) for use in pregnancy. In August 2000, the manufacturer of misoprostol warned against its use in pregnancy because of its abortifacient properties and cited reports of maternal and fetal deaths when misoprostol was used to induce labor, fueling the misoprostol controversy. More than 45 randomized trials including more than 5400 women have found vaginal misoprostol to be more effective than oxytocin or vaginal prostaglandin E2 at effecting vaginal delivery within 24 hours. Cesarean delivery rates with vaginal misoprostol are lower than with oxytocin alone, but similar to prostaglandin E2. There have been no significant differences in the frequency of serious adverse maternal or neonatal outcomes with low-dose misoprostol compared with oxytocin or prostaglandin E2; however, the relative risk of rare adverse outcomes with misoprostol is unknown. The data suggest that absolute risks are low when misoprostol is used appropriately. We recommend 25 mcg vaginally every 4 to 6 hours for carefully selected patients in closely monitored settings. Whether misoprostol will prove to be the most cost-effective agent for inducing labor in women with an unfavorable cervix remains to be determined.