Trial Outcomes & Findings for Comparative Effectiveness of Pregnancy Failure Management Regimens (NCT NCT02012491)

NCT ID: NCT02012491

Last Updated: 2019-07-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 300 participants
• Primary outcome timeframe: Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done
• Results posted on: 2019-07-18

Participant Flow

We randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed to receive pretreatment with 200 mg of mifepristone, orally, followed by 800 μg of misoprostol, administered vaginally (mifepristone-pretreatment group), or 800 μg of misoprostol alone, administered vaginally (misoprostol-alone group).

Participant milestones

Measure	Misoprostol 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone
Overall Study STARTED	151	149
Overall Study COMPLETED	149	148
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Misoprostol 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Comparative Effectiveness of Pregnancy Failure Management Regimens

Baseline characteristics by cohort

Measure	Misoprostol n=151 Participants 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone n=149 Participants 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone	Total n=300 Participants Total of all reporting groups
Age, Customized Participant's age	30.2 years n=5 Participants	30.7 years n=7 Participants	30.4 years n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants	149 Participants n=7 Participants	300 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	67 Participants n=5 Participants	65 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants	57 Participants n=7 Participants	109 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	151 participants n=5 Participants	149 participants n=7 Participants	300 participants n=5 Participants
Diagnosis Anembryonic gestation	37 Participants n=5 Participants	40 Participants n=7 Participants	77 Participants n=5 Participants
Diagnosis Embryonic of fetal death	114 Participants n=5 Participants	109 Participants n=7 Participants	223 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done

Outcome measures

Measure	Misoprostol n=149 Participants 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone n=148 Participants 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone
Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment.	100 Participants	124 Participants

PRIMARY outcome

Timeframe: Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)

Outcome measures

Measure	Misoprostol n=149 Participants 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone n=148 Participants 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone
Gestational Sac Expulsion by the Second Follow-up Visit at Day 8	111 Participants	132 Participants

PRIMARY outcome

Timeframe: 30 Days

Outcome measures

Measure	Misoprostol n=149 Participants 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone n=148 Participants 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone
Gestational Sac Expulsion by the 30-day Telephone Call	113 Participants	135 Participants

PRIMARY outcome

Timeframe: 30 Days

Surgical removal of the miscarriage.

Outcome measures

Measure	Misoprostol n=149 Participants 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone n=148 Participants 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone
Uterine Asperation	35 Participants	13 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Misoprostol n=151 Participants 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone n=149 Participants 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone
Frequency of Serious Adverse Events Between Study Arms.	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 30 Days

Outcome measures

Measure	Misoprostol n=151 Participants 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone n=149 Participants 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone
Adverse Event Reported by Participants	5.6 adverse events Interval 0.0 to 843.0	6.1 adverse events Interval 0.0 to 904.0

Adverse Events

Misoprostol

Serious events: 3 serious events

Other events: 115 other events

Deaths: 0 deaths

Misoprostol Plus Mifepristone

Serious events: 5 serious events

Other events: 118 other events

Deaths: 0 deaths

Serious adverse events

Measure	Misoprostol n=151 participants at risk 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone n=149 participants at risk 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone
Blood and lymphatic system disorders Bleeding resulting in blood transfusion	0.66% 1/151 • Number of events 1 • Adverse events were collected over a 30 day time frame	2.0% 3/149 • Number of events 3 • Adverse events were collected over a 30 day time frame
Reproductive system and breast disorders Pelvic Infection	1.3% 2/151 • Number of events 2 • Adverse events were collected over a 30 day time frame	1.3% 2/149 • Number of events 2 • Adverse events were collected over a 30 day time frame

Other adverse events

Measure	Misoprostol n=151 participants at risk 800 micrograms of vaginal misoprostol alone Misoprostol	Misoprostol Plus Mifepristone n=149 participants at risk 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Misoprostol Mifepristone
General disorders Fatigue	76.2% 115/151 • Adverse events were collected over a 30 day time frame	79.2% 118/149 • Adverse events were collected over a 30 day time frame

Additional Information

Dr. Courtney Schreiber

University of Pennsylvania

Phone: 215-615-5234

Email: Courtney.Schreiber@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place