Mifepristone vs Misoprostol
NCT Number: NCT06502158
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Cervical Preparation
Interventions: DRUG: Mifepristone|DRUG: Misoprostol
Sponsor: Montefiore Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 94
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08
Locations: Montefiore Medical Center, Bronx, New York, 10467, United States

Summary:
The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.

Primary Outcome Measures: Percentage of participants achieving Intended dilation, The proportion of participants achieving intended dilation at the start of the procedure will be summarized by treatment group and reported in percentages. Achievement of intended dilation will be determined by the attending surgeon. Overdilation resulting in passage of products of conception prior to time of surgery will be characterized as a treatment failure., At time of surgery
Secondary Outcome Measures: Cervical dilation at start of procedure, Cervical dilation in centimeters (cm) at start of procedure will be summarized and reported using basic descriptive statistics., Start of the Procedure|Surgical time, Total surgical time will quantified and reported by treatment arm using basic descriptive statistics., Start to end of procedure, up to 4 hours|Estimated blood loss, Estimated blood loss will be quantified and reported per treatment arm using basic descriptive statistics., Start to end of procedure, up to 4 hours|Presence of Intraoperative Complications, The presence of peri-operative complications, defined as instances of hemorrhage, use of uterotonic medications, passage of products of conception prior to time of surgery, instances of extramural delivery, or need for unscheduled procedures, will be summarized and reported as "Yes" or "No" using basic descriptive statistics., From preoperative visit to discharge, up to 2 days|Patient Satisfaction, Patient Satisfaction will be assessed by responses to a survey administered in the Postoperative Care Unit (PACU) following the procedure. The patient will be asked to rate their satisfaction with the procedure on a 6-point Likert scale ranging from 0 (Not at all satisfied) to 5 (Most satisfied). Responses will be summarized by treatment group using basic descriptive statistics. Increased scores are associated with increased satisfaction., From preoperative visit to discharge, up to 2 days|Provider Satisfaction, Provider Satisfaction will be assessed by responses to a survey administered following the procedure. The care provider will be asked to rate their satisfaction with the procedure on a 6-point Likert scale ranging from 0 (Not at all satisfied) to 5 (Most satisfied). Responses will be summarized by treatment group using basic descriptive statistics. Increased scores are associated with increased satisfaction., From preoperative visit to discharge, up to 2 days