Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15-18 weeks' gestation: a randomised controlled non-inferiority trial.

OBJECTIVE: Cervical preparation is recommended prior to second-trimester surgical abortion. Osmotic dilators are an effective means to prepare the cervix, but require an additional procedure and may cause discomfort. We compared cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators. STUDY DESIGN: A randomised, controlled, non-inferiority trial was performed to compare cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators in women undergoing surgical abortion between 15 and 18 weeks gestation. The medication group (n=29) received mifepristone 200 mg orally 24 hours prior to uterine evacuation and misoprostol 400 µg buccally 2 hours before the procedure. The dilator group (n=20) underwent osmotic dilator insertion 24 hours prior to the procedure. The primary outcome was total procedure time, from insertion to removal of the speculum. Secondary outcomes included operative time (from intrauterine instrumentation to speculum removal), initial cervical dilation, nausea, pain, ease of procedure, and whether participants would choose the same modality in the future. RESULTS: For mean total procedure time, medication preparation (14.0 min, 95% CI 12.0-16.1) was not inferior to dilators (14.3 min, 95% CI 11.7 to 16.8, p<0.001). Mean operative time and ease of procedure were also similar between groups. More women in the medication group than the dilator group would prefer to use the same method in the future (86% vs 30%, p=0.003). CONCLUSION: Prior to surgical abortion at 15-18 weeks, use of mifepristone and misoprostol did not result in longer procedure times than overnight osmotic dilators. TRIAL REGISTRATION NUMBER: NCT01462.

Addressing the Global Zika Epidemic Locally: An Interprofessional Model of Universal Screening at One Center.

Escalating evidence for the fetal impact of Zika virus infection required a change in care by all prenatal providers. This article describes an effective model of rapid implementation of universal prenatal screening at one hospital and its network of community health centers for a large and diverse immigrant population exploring the challenges, experiences, and lessons learned. Implementation of national recommendations required a workflow change, challenging a system with a heterogeneity of settings and providers. Using a physician clinical champion and advanced practice nurses in the roles of logistical coordinator and liaison to the network, Zika screening was embedded into prenatal intake visits at both the hospital and community health centers. Challenges addressed include varied medical record systems, acceptance by patients, providers, and community health center leadership, as well as culturally appropriate outreach to diverse ethnic and linguistic communities. In 6 months, the prenatal screening rates increased from 20% to 88%, which resulted in the identification of more than 300 pregnant patients at risk of exposure to Zika virus. This model offers key lessons for emergency preparedness in heterogeneous, safety net hospital settings.

Inflammation or infection at the time of second trimester induced abortion.

BACKGROUND: Induced abortion via dilation and evacuation (D&E) typically involves cervical preparation. Some clinicians also induce fetal death in the second trimester. We designed this study to determine if the combination of intra-amniotic digoxin and osmotic dilators induced intrauterine inflammatory changes. STUDY DESIGN: Twenty-two women requesting abortion at 19-23 weeks gestation had amniotic fluid sent for measurement of interleukin-6 (IL-6), interleukin-8 (IL-8), tumor necrosis factor-α (TNF-α), white blood cell (WBC) count and anaerobic and aerobic cultures on day 1, before dilators and digoxin amnioinjection. Sampling was repeated on Day 2, prior to D&E. RESULTS: All subjects had significantly elevated IL-6, IL-8 and TNF-α in the amniotic fluid on Day 2. The median difference for IL-6 was 19,893.4 pg/mL (p<.0001), 7040.7 pg/mL (p<.0001) for IL-8 and 181.0 pg/mL (p<.0001) for TNF-α. There was no significant difference in WBC count. There were no clinically significant positive cultures and no clinical infections. CONCLUSION: The administration of intra-amniotic digoxin and the placement of osmotic dilators prior to D&E create an intrauterine inflammatory response.

Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial.

BACKGROUND: Cervical preparation is recommended before second-trimester abortion. We investigated the use of a pharmacologic method of preparation, mifepristone, as compared to osmotic dilators for surgical abortions at 14-16 weeks. STUDY DESIGN: This was a randomized, parallel-group study with concealed allocation. Women were allocated to receive osmotic dilators or mifepristone 200 mg orally 24 h prior to abortion. The study population was 50 women seeking surgical abortion at 14-16 menstrual weeks in a hospital-based abortion service. The primary outcome was the length of time to perform the procedure; the study had 80% power to detect a difference of more than 3 min in procedure time. Secondary outcomes included cervical dilation, side effects and acceptability. RESULTS: The mean abortion time for the osmotic dilator group was 8.00 min [95% confidence interval (CI) 6.75-11.47], and that for the mifepristone group was 9.87 min (95% CI 8.93-11.36). Side effects of pain were more common in the osmotic dilator group. CONCLUSION: Mifepristone did not increase the time for abortion by more than the prespecified margin (3 min). Women preferred mifepristone to osmotic dilators.