NCT03714880

Cervical Preparation With Mifepristone Prior to Osmotic Dilators

Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The investigators plan to study the role of mifepristone prior to the placement of cervical osmotic dilators to evaluate if the medication helps increase the number of dilators. This may help improve safety of dilation and evacuation (D\&E) procedures.

Detailed description

No clear guideline currently exists for best practices involving cervical preparation for women planning dilation and evacuation at 20 weeks and greater. The investigators plan to perform a pilot, randomized, double-blind, placebo-controlled trial. On day 1, 66 participants will receive mifepristone 200 mg orally or placebo 18-24 hours prior to osmotic dilator (Dilapan-S 4-mm) placement (day 2). On day 3, participants will have a D\&E procedure. Enrollees will be 18 weeks 0 days to 23 weeks 6 days gestation on the day of the procedure. The primary objective is to evaluate the role of adjunctive mifepristone the day prior to osmotic dilator placement for dilation and evacuation procedures. The primary outcome will be the number of dilators successfully placed. Investigators will compare the number of dilators placed between study arms stratified by gestational age. Secondary outcomes include cervical dilation at time of procedure, proportion of women requiring mechanical dilation at time of surgery, provider impression on ease of procedure and/or difficulty in dilating the cervix when clinically required, and overall complications. Complications or adverse events include cervical laceration requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infection, additional surgical procedures, or extramural deliveries.

Conditions

• Second Trimester Abortion

Interventions

Type	Name	Description
DRUG	Mifepristone 200 MG	Ingestion of study medication vs placebo
DRUG	Placebo Oral Tablet	Ingestion of study medication vs placebo

Timeline

• Start date: 2019-04-26
• Primary completion: 2021-02-26
• Completion: 2021-02-26
• First posted: 2018-10-22
• Last updated: 2022-06-08
• Results posted: 2022-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study