Heather L. Hohmann

Postplacental or Delayed Insertion of the Levonorgestrel Intrauterine Device After Vaginal Delivery: A Randomized Controlled Trial

OBJECTIVE: To estimate whether 6-month use of the levonorgestrel-releasing intrauterine device (IUD) would be higher when insertion occurred within 10 minutes of placental delivery compared with 6–8 weeks postpartum. METHODS: We enrolled pregnant women planning vaginal deliveries and desiring a postpartum levonorgestrel-releasing IUD. Patients were randomly assigned when admitted in labor to postplacental or delayed IUD insertion. The women followed up in person at 6–8 weeks and 6 months and were contacted by telephone at 3 months. Women were ineligible for a study IUD postenrollment for intrapartum events including infection, hemorrhage, and cesarean delivery; these women were contacted by phone at 3 and 6 months. Expelled IUDs were replaced per patient preference. RESULTS: Successful IUD placement occurred in 50 of 51 participants (98.0%) and 46 of 51 participants (90.2%) in the postplacental and delayed groups, respectively (P=.2). Expulsion within 6 months occurred in 12 of 50 (24.0%; 95% confidence interval [CI], 13.1–38.2) and two of 46 (4.4%; 95% CI 0.5–14.8) participants, respectively (P=.008). Intrauterine device use at 6 months was 43 of 51 (84.3%; 95% CI 71.4–93.0) and 39 of 51 (76.5%; 95% CI 62.5–87.2), respectively (P=.32). For ineligible patients, only 11 of 41 (26.8%) women were using IUDs at 6 months and two (4.9%) had become pregnant. CONCLUSION: Intrauterine device use 6 months after delivery is similar in women who have postpartum or scheduled delayed IUD placement through a study after replacement of expelled IUDs. Expulsions are significantly higher with postplacental compared with delayed IUD placement. Women asked to follow up with their own health care providers for delayed insertion are significantly less likely to receive an IUD. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00476021. LEVEL OF EVIDENCE: I

Feasibility of telephone follow-up after medical abortion

BACKGROUND This study was conducted to assess the feasibility of using telephone calls combined with high-sensitivity urine pregnancy testing as a primary method of follow-up after medical abortion. METHODS We enrolled 139 women up to 63 days of gestation to receive mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, per their choice. Participants were contacted by phone one week after mifepristone administration and interviewed using standardized questions. If the subject or clinician thought the pregnancy was not expelled, the subject returned for an ultrasound examination. Otherwise, subjects performed high-sensitivity home urine pregnancy testing 30 days after the mifepristone and were called within 3 days of the test. Those with positive pregnancy tests returned for an ultrasound examination. Those with negative tests required no further follow-up. RESULTS Six of the 139 (4.3%, 95% CI 1.6-9.1%) subjects presented prior to Phone Call 1 for an in-person visit. All 133 (100%, 95% CI 97.8-100%) subjects eligible for their first telephone follow-up were contacted. Eight of the 133 (6.1%, 95% CI 2.6-11.5%) women were asked to return for evaluation and all did so (100%, 95% CI 63.1-100%). Eight of the 133 women eligible for the 30 day phone call presented for an interim visit prior to the call. After 30 days, 116 of the 117 (99.1%, 95% CI 97.5-100%) eligible subjects were contacted. One subject was not reached for the day 30 phone call. Twenty-seven of the 116 (23.3%, 95% CI 15.6-31.0%) subjects had a positive pregnancy test and required follow-up. Two of these subjects (7.4%, 95% CI 1.0-24.2%) did not return for in-person follow-up. Two of the 116 (1.7%, 95% CI 0.2-6.1%) subjects had inconclusive pregnancy tests and were asked to return for follow-up. One of these subjects (50%, 95% CI 1.2-98.7%) did not return. Complete follow-up was achieved in 135 of the 139 subjects (97.1%, 95% CI 94.3-99.9%). None of the 26 women evaluated for a positive or inconclusive pregnancy test had a gestational sac or continuing pregnancy. CONCLUSION Telephone follow-up combined with urine pregnancy testing after medical abortion is a feasible alternative to routine ultrasonography or serial serum hCG measurements.

The contraceptive implant

Contraceptive implants provide long-acting, highly effective reversible contraception. Currently, the only subdermal implant available to women in the United States is the single rod etonogestrel implant, Implanon (N.V. Organon, Oss, the Netherlands) approved by the Food and Drug Administration in July 2006. Implanon is currently approved for 3 years of use, provides excellent efficacy throughout its use, and is easy to insert and remove. Similar to other progestin-only contraceptives, Implanon can cause irregular vaginal bleeding. Implanon has been shown to be safe to use during lactation, may improve dysmenorrhea, and does not significantly affect bone mineral density, lipid profile, or liver enzymes.

Immediate versus delayed insertion of the levonorgestrel-releasing intrauterine device following dilation and evacuation: a randomized controlled trial

BACKGROUND The study was conducted to compare 6-month usage of the levonorgestrel-releasing intrauterine device (LNG-IUD) when placed immediately or 3 to 6 weeks after dilation and evacuation (D&E) procedure. STUDY DESIGN We enrolled women undergoing D&E at 15 to 23 weeks of gestation. After completion of the D&E, subjects without contraindications to immediate IUD insertion were randomized to immediate or delayed (3 to 6 weeks later) LNG-IUD insertion. Subjects in the immediate group had the LNG-IUD placed using ultrasound guidance. All subjects returned at 3 to 6 weeks and 8 to 10 weeks after D&E and were contacted by phone at 6 months. RESULTS Of the 93 subjects enrolled, 88 were randomized. All 44 subjects (100%) randomized to immediate insertion had successful IUD placement, while only 20 (45.5%) of the 44 subjects randomized to delayed insertion returned for IUD placement, all of which were successful [difference 54.5%, 95% confidence interval (CI) 39.8%-69.3%]. Seventeen (38.6%) participants in each group were lost to follow-up. Of subjects contacted at the 6-month follow-up phone call, 23 of 27 women (85.2%) and 17 of 27 women (62.9%) were utilizing the LNG-IUD in the immediate and delayed groups, respectively (difference 22.2%, 95% CI -0.4% to 44.8%). Intrauterine device expulsion occurred in three subjects (6.8%) and one subject (5.0%) in whom the IUD was placed in the immediate and delayed groups, respectively (p=1.0). No significant adverse events occurred. CONCLUSION Significantly more participants had the LNG-IUD placed in the immediate insertion group compared with the delayed insertion group. Given the low risk of complications, immediate post-D&E insertion of the LNG-IUD should be offered, especially for populations that may have difficulty returning for follow-up.

Transvaginal administration of intraamniotic digoxin prior to dilation and evacuation

BACKGROUND Transabdominal injection of digoxin into the amniotic fluid or fetus to induce fetal demise before dilation and evacuation (D&E) abortion has become common practice since the passage of the Partial-Birth Abortion Ban Act in 2007. STUDY DESIGN We performed a prospective study to assess the feasibility of transvaginal administration of intraamniotic digoxin the day before D&E. All women between 18 0/7 and 23 5/7 weeks of gestation seeking termination from December 2009 to May 2011 were approached for study participation. Women who declined participation were asked to identify their primary rationale. For women declining study participation, transection of the umbilical cord during D&E was performed to meet the requirements of the ban. RESULTS Over 18 months, 134 women met study entry criteria and 108 (81%) declined to participate. Of the 26 women who enrolled, 1.0 mg undiluted digoxin was successfully administered transvaginally in 24 (92%, 95% confidence interval 75%-99%). The most common reasons for declining participation were discomfort with preoperatively inducing fetal demise (37%) and desire to avoid a medically unnecessary medication (36%). CONCLUSIONS Transvaginal administration of digoxin is a feasible alternative to transabdominal administration to induce preoperative fetal demise. The majority of women decline digoxin administration when an alternative is available.

Women's motivation to participate in contraceptive efficacy trials

BACKGROUND We sought to determine whether there are differences in subjects motivation to participate in hormonal and barrier method contraceptive efficacy studies. STUDY DESIGN All women presenting for screening appointments for either barrier or hormonal contraceptive efficacy trials were asked to complete a survey including demographic questions and questions which utilized Likert scales to grade the importance of potential motivating factors for research participation. RESULTS A total of 72 hormonal and 36 barrier method subjects completed the survey. More women in the barrier group cited an altruistic reason as their primary motivator for participation in comparison to the hormonal group (61.2% vs. 31.9%, respectively, p=.004). This difference continued to be statistically significant in multiple logistic regression controlling for demographic variables. The most common primary motivating factor cited by the barrier group was the belief that research is important (30.6%), whereas the most common reason cited by the hormonal group was the desire for free contraception (22.2%). CONCLUSION Women enrolling in barrier method studies are more likely than women enrolling in hormonal studies to cite an altruistic reason for their participation in these trials.