Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial.

OBJECTIVE: To assess cabergoline's efficacy at decreasing breast symptoms after second-trimester abortion or pregnancy loss. METHODS: This was a double-blinded, block-randomized superiority trial comparing cabergoline 1 mg once to placebo for preventing bothersome breast engorgement after second-trimester uterine evacuation. We enrolled pregnant people at 18-28 weeks of gestation who were English- or Spanish-speaking and without contraindication to the study drug. Participants completed a validated, piloted, electronic survey at baseline and at multiple timepoints through 2 weeks postprocedure to assess breast symptoms, side effects, and bother. Our primary outcome was any breast symptoms (a composite of engorgement, milk leakage, tenderness, and need for pain relief) on day 4; we planned to enroll 80 patients to show a 30% difference in breast symptoms (80% power, α=0.049). A subgroup of participants returned for serum prolactin levels. RESULTS: After screening 150 patients from April 2021 to June 2022, we enrolled 73 participants. Baseline demographics were balanced between groups: median gestational age was 21 weeks (range 18-26 weeks), 56.2% of participants were nulliparous, 34.2% self-identified as Hispanic, and 37.0% had public insurance. At baseline, reported breast symptoms were similar between groups. Among 69 participants who returned surveys on day 4, significantly fewer participants receiving cabergoline reported any breast symptoms compared with placebo (27.8% vs 97.0%, P<.001) (primary outcome) and fewer reported significant bother (2.8% vs 33.3%, P=.001) (secondary outcome). These differences persisted through day 14. Reported incidence and severity of bother from side effects were similar between groups: most common were constipation, fatigue, and headache. Serum prolactin levels were similar at baseline. On day 4, mean serum prolactin level was 6.5 ng/mL (SD 2.2) for those who received cabergoline and 18.0 ng/mL (SD 5.9) for placebo (P=.049). CONCLUSION: Cabergoline is an effective and well-tolerated strategy to prevent breast symptoms after second-trimester abortion or pregnancy loss. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04701333.

Gabapentin as an adjunct for pain management during dilation and evacuation: A double-blind randomized controlled trial.

OBJECTIVES: To assess the analgesic efficacy of preoperative gabapentin among patients undergoing dilation and evacuation (D&E) with moderate sedation. STUDY DESIGN: We conducted a randomized, controlled, double-blind trial among patients undergoing same-day D&E at 14 to 19 weeks gestation under moderate sedation. We randomized participants 1:1 to gabapentin 600 mg or placebo after cervical preparation at least 1 hour prior to D&E. We assessed pain using a 100-mm visual analog scale before, during, and after the procedure. The primary outcome was postoperative recall of maximum procedural pain with a 13-mm a priori threshold for clinical significance. We standardized initial fentanyl and midazolam dosing. We assessed satisfaction with pain control, nausea, and vomiting via Likert scales and anxiety using a validated instrument. RESULTS: We enrolled 126 participants and randomized 61 to gabapentin and 65 to placebo, with study medication administered a mean of 211 (SD 64) minutes preoperatively. Recall of maximum pain was 41 mm for gabapentin and 49 mm for placebo (p = 0.24). Gabapentin resulted in reduced pain during uterine aspiration (56 vs 71 mm, p= 0.003) compared to placebo, but not for any other time points. The gabapentin group had higher satisfaction (78% vs 65% very or somewhat satisfied, p= 0.01). Median fentanyl dose was lower in the gabapentin group (75 vs 100 mcg, p = 0.005). Midazolam dose, nausea, vomiting, and anxiety did not differ between groups. No serious adverse events occurred in the gabapentin group. Sedation reversal was not required. CONCLUSIONS: The addition of gabapentin to moderate sedation during D&E did not result in lower maximum recalled procedural pain. Gabapentin resulted in reduced intra-operative pain during uterine aspiration and increased satisfaction with pain control. IMPLICATIONS: Gabapentin reduces intraoperative pain and improves satisfaction with pain management when administered prior to second-trimester surgical abortion and may be considered as an adjunct to intravenous sedation. Moderate sedation may impair assessment and recall of pain. Additional research is needed to identify the most effective pain management regimens for D&E.

Transabdominal lidocaine to induce fetal demise: a cohort study.

INTRODUCTION: We sought to assess the efficacy of transabdominal intrafetal lidocaine to achieve fetal demise before pregnancy termination. METHODS: This study was a retrospective cohort analysis of patients undergoing transabdominal intrafetal lidocaine injections prior to abortion procedures after 24 weeks from January 2018 to June 2020 at DuPont Clinic, an outpatient obstetrics and gynaecology clinic in Washington, DC, USA. We recorded data on maternal factors, gestational age, time of injection and fetal asystole, and injection dose and location. We defined successful intrafetal lidocaine injection as asystole achieved prior to the patient leaving the clinic. RESULTS: We performed injections in 338 fetuses in 335 patients, with a median gestational age of 27 weeks and 6 days (range 24-32 weeks). Lidocaine dose was 200-240 mg in 310 cases (91.7%) and 400-480 mg in 27 cases (8.0%) without difference in success (p>0.05). Lidocaine successfully induced fetal demise with one injection in 331 cases (97.9%). A second injection was required to induce demise for five fetuses (1.5%). Intracardiac injection was successful in 280 of 285 cases (98.3%), with asystole confirmed within 1 min in 75% of cases. Intrathoracic injection caused asystole in 45 of 47 cases (95.7%), with asystole confirmed within 2 min in 75% of cases. Success was not significantly associated with gestational age, body mass index or parity (p>0.05). One patient reported lidocaine-related side effects (0.3%). CONCLUSIONS: Intrafetal lidocaine is a safe and effective method of inducing fetal demise. Intracardiac injection achieves fetal asystole almost immediately. Intrathoracic injection is also highly effective.

A factorial-design randomized controlled trial comparing misoprostol alone to Dilapan with misoprostol and comparing buccal to vaginal misoprostol for same-day cervical preparation prior to dilation & evacuation at 14 weeks 0 days-19 weeks 6 days gestation.

OBJECTIVES: To compare procedure times following same-day cervical preparation using misoprostol 400 mcg alone or misoprostol 400 mcg plus hygroscopic dilators for dilation and evacuation (D&E) before 20 weeks gestation and to compare side effects of buccal and vaginal misoprostol administration. STUDY DESIGN: We randomized women undergoing D&E at 14 weeks 0 days-19 weeks 6 days gestation to receive (1) hygroscopic dilators or not and (2) buccal or vaginal misoprostol using a 2 × 2 factorial design. We assessed two primary outcomes: (1) total procedure time, defined as time to insert hygroscopic dilators plus D&E time, and (2) side effects of misoprostol 4-6 h after initiation of cervical preparation using a 5-point Likert scale assessing nausea, emesis, diarrhea, chills and cramps. RESULTS: We randomized 163 women and 161 completed the study. We completed all procedures in one day. Mean total procedure time was 14.0 and 10.8 min. with and without hygroscopic dilators (difference 3.2 minutes, 95% CI 1.7, 4.6). Mean D&E procedure time was 0.7 (95% CI -0.8, 2.1) min longer without hygroscopic dilators. Initial cervical dilation was 15.6 and 11.7 mm with and without hygroscopic dilators (difference 3.9 mm, 95% CI 3.1, 4.8). Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p = 0.04. CONCLUSIONS: Hygroscopic dilators with misoprostol requires more time and increases cervical dilation without shortening D&E time when used for cervical preparation 4-6 h prior to D&E before 20 weeks. Women receiving vaginal misoprostol may have more chills compared to buccal misoprostol. IMPLICATIONS: Adding hygroscopic dilators to misoprostol for same day D&E procedures at less than 20 weeks gestation increases total intervention time without reducing D&E time and is less favored by patients. Clinical judgment requires balancing relative effectiveness with patient preference. Further studies should evaluate the side effect profile of vaginal misoprostol.

A randomized comparison of a novel nitinol-frame low-dose-copper intrauterine contraceptive and a copper T380S intrauterine contraceptive.

OBJECTIVE: We sought to compare VeraCept (VC175), a novel nitinol intrauterine contraceptive (IUC) with 175 square-mm of copper surface area, to a copper T380S IUC. STUDY DESIGN: We enrolled parous women into a randomized subject-blinded comparison of VC175 and a copper T380S in a 2:1 fashion at a single clinic. The primary outcomes were total adverse events and continuation at 12 months. We also examined pain on insertion, ease of placement, expulsion, tolerability and pregnancy. Subjective ratings were on a 5-point Likert scale (0, no pain to 5, worst pain). We followed subjects through 24-month follow-up. RESULTS: We enrolled 300 women with 199 randomized to VC175 and 101 to the T380S. Insertion was successful in 198 subjects for VC175 and 100 for the T380S. Mean age was 25 years (range 18, 41), and median parity was 2 (range 1, 8), with 39% having only had Cesarean deliveries. No subjects developed clinical infection or reported serious adverse events. In the VC175 and T380S groups, mean pain at insertion was 1.4 and 2.4, respectively (p<.01). At the 12-month primary endpoint for VC175 and T380S, respectively, continuation was 84% and 68% (p<.002) with expulsions in 5.0% and 12.0% (p<.05) and removal for pain/bleeding in 3.5% and 17.0% (p<.01). At the 24-month visit for VC175 and T380S, respectively, continuation was 77% and 62% (p<.02 by log-rank). One ectopic pregnancy was identified at the 12-month follow-up in a VC175 user. No other pregnancies were diagnosed. With 297.3 and 132.4 woman-years, pregnancy rates were 0.3 and 0.0 per 100 woman-years for VC175 and T380S, respectively. CONCLUSIONS: VC175 resulted in less pain at insertion, fewer expulsions and higher total continuation than the T380S, with similar contraceptive efficacy. IMPLICATIONS: VC175 is a promising new intrauterine copper contraceptive on a nitinol frame that warrants further clinical trials.

Update on abortion policy.

PURPOSE OF REVIEW: To review the status of antiabortion restrictions enacted over the last 5 years in the United States and their impact on abortion services. RECENT FINDINGS: In recent years, there has been an alarming rise in the number of antiabortion laws enacted across the United States. In total, various states in the union enacted 334 abortion restrictions from 2011 to July 2016, accounting for 30% of all abortion restrictions since the legalization of abortion in 1973. Data confirm, however, that more liberal abortion laws do not increase the number of abortions, but instead greatly decrease the number of abortion-related deaths. Several countries including Romania, South Africa and Nepal have seen dramatic decreases in maternal mortality after liberalization of abortion laws, without an increase in the total number of abortions. In the United States, abortions are incredibly safe with very low rates of complications and a mortality rate of 0.7 per 100 000 women. With increasing abortion restrictions, maternal mortality in the United States can be expected to rise over the coming years, as has been observed in Texas recently. SUMMARY: Liberalization of abortion laws saves women's lives. The rising number of antiabortion restrictions will ultimately harm women and their families.

A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion.

OBJECTIVE: We evaluated initial cervical dilation with the addition of oral mifepristone to vaginal misoprostol as cervical preparation for same-daysecond-trimester dilation and evacuation (D&E). STUDY DESIGN: Women desiring abortion between gestational ages 14weeks 0days and 19weeks 6days were randomized to 200-mg mifepristone or identical placebo immediately followed by 400-mcg misoprostol vaginally 4-6h prior to D&E. Primary outcome was cervical dilation assessed by largest Hegar dilator passed without resistance. Secondary outcomes included total procedure time and participant and provider perceptions. We had 90% power to detect a 2-mm change in initial cervical dilation with a mean of 10mm (SD=3.0mm), requiring 48 participants in each arm. RESULTS: Of 100 women enrolled, 96 were randomized and completed the study. Age, race, gestational age (mean 17.4weeks, SD=1.3) and parity did not significantly differ. Mean initial Hegar dilation measurements were 11.7 and 10.9mm in the mifepristone and placebo groups, respectively, with difference of 0.8 [95% CI=-0.4, 2.0mm]. We found total procedure times of 11.8 and 13.0min, respectively (difference of 1.2min [95% CI=-2.4, 4.8min]. Participant and provider perceptions did not differ. All 96 procedures were completed without hemorrhage, cervical laceration or other observed complications. CONCLUSION: The addition of mifepristone to vaginal misoprostol did not provide a significant increase in cervical dilation compared to misoprostol alone as cervical preparation 4-6h prior to D&E at 14weeks through 19weeks 6days. IMPLICATIONS: Adding mifepristone for a short interval (4-6h) did not improve cervical preparation with misoprostol prior to D&E at 14-19weeks. Future studies should evaluate alternative timing intervals of medications for this purpose.

Risk of unintended pregnancy based on intended compared to actual contraceptive use.

BACKGROUND: After initiating a new contraceptive method, the provider has little control of how or whether that method is used. OBJECTIVE: We sought to compare unintended pregnancy rates by the initial chosen contraceptive method after counseling to traditional contraceptive effectiveness in the same study population. STUDY DESIGN: The Contraceptive CHOICE Project provided reversible contraception to 9252 women at no cost during 2-3 years of follow-up. We performed 2 analyses of contraceptive efficacy in this prospective cohort: (1) intent-to-use (ITU), grouping participants based on their chosen method at enrollment; and (2) as-used, categorizing participant time according to the method used. In ITU analysis, switching of methods and method continuation were not considered, as we wanted to assess outcomes based on the method chosen at baseline. We used Cox proportional hazards models to compare rates of unintended pregnancy. RESULTS: During 20,017 person-years, we identified 615 unintended pregnancies. In ITU analysis, pregnancy rates were 5.3, 5.5, 2.0, 1.7, and 1.9 per 100 person-years for women initiating oral, injectable, implantable, copper, and hormonal intrauterine contraception (IUC) at baseline, respectively. The adjusted hazard ratio for injectable contraception compared to hormonal IUC was 2.4 (95% confidence interval, 1.8-3.3). Delaying initiation of IUC or implantable contraception increased unintended pregnancies by 60% (adjusted hazard ratio, 1.6; 95% confidence interval, 1.2-2.0). In as-used analysis, pregnancy rates were 6.7, 1.6, 0.2, 0.6, and 0.2 per 100 person-years for women using oral, injectable, implantable, copper, and hormonal IUC, respectively. CONCLUSION: Although highly effective in the as-used analysis, women initially choosing injectable contraception had pregnancy rates similar to oral contraception and significantly worse than IUC or implantable contraception. Despite switching and discontinuation, women choosing an IUC or implantable contraception at baseline were much less likely to have an unintended pregnancy compared to those selecting other methods.

Predictors of uterine evacuation following early medical abortion with mifepristone and misoprostol.

OBJECTIVES: We sought to determine predictors of uterine evacuation for women undergoing medical abortion using mifepristone and vaginal misoprostol through 63 days' gestation. STUDY DESIGN: We pooled data from two prospective multicenter medical abortion trials. In one study, women received mifepristone 200 mg followed either 6-8 or 23-25 h later by misoprostol 800 mcg vaginally. In the second study, women received mifepristone 200 mg followed either <15 min or 23-25 h later by misoprostol 800 mcg vaginally. We examined the absolute risk (AR) of uterine evacuation using Fisher's Exact Tests for categorical variables and Student t test and Wilcoxon rank-sum tests for continuous variables. We used logistic regression to calculate odds ratios (ORs) of uterine evacuation. RESULTS: Uterine evacuation was performed for 75 (3.5%) of 2160 women. In multivariable analysis, 5 or more prior deliveries (AR 11.9%, OR 4.6) and gestational age of 8 weeks or more (AR 4.1%, OR 2.1) were significantly associated with uterine evacuation, while age of 20 years or younger (AR 1.4%, OR 0.4) was significantly and inversely associated with uterine evacuation. Prior cesarean delivery, multiple gestations, smoking, weight, body surface area and body mass index were not predictive of uterine evacuation in univariate or multivariable analysis. CONCLUSION: Uterine evacuation is an uncommon outcome in medical abortion with mifepristone and vaginal misoprostol. Five or more deliveries are the only significant predictor that identifies a group with an AR of uterine evacuation of more than 6%. IMPLICATIONS: Uterine evacuation is uncommon in medical abortion with mifepristone and vaginal misoprostol. Parity of five or more is the only significant predictor of uterine evacuation exceeding 6%. Until additional research is completed, medical abortion should not be withheld from women with five or more deliveries.

Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial.

OBJECTIVE: To evaluate if ibuprofen 800mg reduces pain with intrauterine device (IUD) insertion among U.S. women. STUDY DESIGN: We conducted a randomized, double-blind, placebo-controlled trial of women undergoing IUD insertion approximately 2-6weeks following first-trimester uterine aspiration. Subjects were randomized to receive ibuprofen 800mg or placebo 30-45min prior to IUD insertion. A 100-mm visual analog scale (VAS) was administered to measure pain after speculum insertion (baseline) and immediately following IUD insertion. RESULTS: A total of 202 women were enrolled, with 101 randomized to each group (ibuprofen or placebo). Sociodemographic characteristics and baseline VAS scores were similar between groups. The median pain score with IUD insertion was 41.5mm in the placebo group and 38.0mm in the ibuprofen group (p=.50). Mean and median pain scores did not differ between placebo and ibuprofen when nulliparous and parous women were analyzed independently. Overall, median pain scores were 17.5mm higher in nulliparous women than parous women (p=.004). Median pain scores did not differ by age, IUD-type, history of dysmenorrhea or time since aspiration. CONCLUSIONS: Administration of ibuprofen 800mg prior to IUD insertion does not reduce pain associated with the procedure for U.S. women. Overall, nulliparous women report more pain with IUD insertion than multiparous women.