Mifepristone vs Misoprostol
ConditionCervical Preparation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
English or Spanish-speaking
Capacity to consent
Seeking induced abortion of a singleton pregnancy between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)
Disqualifiers
History of more than two prior Cesarean deliveries
Sonographic evidence of placenta previa
Sonographic concern for morbidly adherent placenta
Prior obstetric hemorrhage requiring transfusion
Trial design
Design model
Parallel
Treatments tested in this trial
Mifepristone
Drug200 milligrams (mg)
Misoprostol
Drug600 micrograms (ug)
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: MifepristoneExperimental treatment 1 intervention
Group B: MisoprostolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At time of surgerySecondary outcomes
1
Cervical dilation at start of procedure
Cervical dilation in centimeters (cm) at start of procedure will be summarized and reported using basic descriptive statistics.
Time frame
Start of the Procedure2
Surgical time
Total surgical time will quantified and reported by treatment arm using basic descriptive statistics.
Time frame
Start to end of procedure, up to 4 hours3
Estimated blood loss
Estimated blood loss will be quantified and reported per treatment arm using basic descriptive statistics.
Time frame
Start to end of procedure, up to 4 hours4
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.
Time frame
From preoperative visit to discharge, up to 2 daysSponsors and contacts
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Source ClinicalTrials.gov