Jennifer L. Hayes

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.

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.

Doxycycline serum levels at the time of dilation and evacuation with two dosing regimens

BACKGROUND Doxycycline is commonly used for antibiotic prophylaxis before dilation and evacuation (D&E) but frequently causes nausea and emesis which may affect absorption and effectiveness. Taking doxycycline the night prior to surgery may result in adequate absorption with better tolerance. STUDY DESIGN We enrolled 40 women into a double-blind randomized comparison of doxycycline 200 mg given 4 h before D&E (Group 1) vs. the night prior to D&E with dinner (Group 2). D&E procedures were scheduled after 11 a.m. and subjects were nil per os on the morning of the procedure. Subjects completed symptom diaries from dilator placement until the D&E. Serum for doxycycline assays was obtained before the D&E. RESULTS Mean gestational age was 19.4 weeks (range 15.8-22.0 weeks) and did not differ by group. Serum was collected at 3.2 h (range 1.9-4.8 h) and 16.3 h (range 13.8-19.1 h) after ingestion of doxycycline in Groups 1 and 2, respectively. Median serum doxycycline levels (milligrams per liter) were 2.7 and 1.8 for Groups 1 and 2, respectively (p=.04). Emesis was experienced by 50% and 15% of women in Groups 1 and 2, respectively (p=.04). Nausea ratings were worse after doxycycline in the morning compared to doxycycline with dinner and compared to placebo at either time (all p<.01). Emesis following doxycycline consumption was not associated with lower doxycycline levels (p>.2). CONCLUSION When given with food on the night prior to D&E, doxycycline results in less emesis and nausea, but results in lower serum levels at the time of D&E.

Outcomes of medical abortion through 63 days in women with twin gestations

BACKGROUND Twin gestation is not considered a contraindication to medical abortion with mifepristone and misoprostol. However, data comparing the efficacy of medical abortion for singleton gestations as compared with multiple gestations are limited. We examined medical abortion outcomes for twin gestations through 63 days. STUDY DESIGN We performed a secondary analysis of treatment efficacy and side effects using pooled data from two randomized medical abortion trials. All subjects received mifepristone 200 mg orally and misoprostol 800 mcg vaginally. Outcomes in women with singleton and twin gestations were compared. RESULTS Of 2208 subjects, 24 (1.1%) women had twins. Treatment success was not statistically different for twin and singleton gestations (91% vs. 97%, p=.19). Perceived bleeding and pain were not significantly different between groups. CONCLUSIONS Treatment success of medical abortion for twins is not significantly different than for singletons, although small differences cannot be excluded due to the limited number of twins.