Trial Outcomes & Findings for Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial (NCT NCT05322252)
NCT ID: NCT05322252
Last Updated: 2026-04-07
Results Overview
Delivery of fetus and placenta
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
12 hours
Results posted on
2026-04-07
Participant Flow
Participant milestones
| Measure |
Simulatenous Mifepristone and Misoprostol
Participants will receive a dose of 200mg oral mifepristone at time of induction with misoprostol
|
Misoprostol Alone
Participants will have labor induced with misoprostol alone
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Misoprostol Alone
n=14 Participants
Participants will have labor induced with misoprostol alone
|
Total
n=29 Participants
Total of all reporting groups
|
Simulatenous Mifepristone and Misoprostol
n=15 Participants
Participants will receive a dose of 200mg oral mifepristone at time of induction with misoprostol
|
|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 4.2 • n=527 Participants
|
30.0 years
STANDARD_DEVIATION 5.9 • n=1054 Participants
|
29.3 years
STANDARD_DEVIATION 7.3 • n=527 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=527 Participants
|
29 Participants
n=1054 Participants
|
15 Participants
n=527 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=527 Participants
|
10 Participants
n=1054 Participants
|
5 Participants
n=527 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=527 Participants
|
19 Participants
n=1054 Participants
|
10 Participants
n=527 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=527 Participants
|
|
BMI
|
30.6 kg/m2
STANDARD_DEVIATION 6.1 • n=527 Participants
|
31.7 kg/m2
STANDARD_DEVIATION 6.7 • n=1054 Participants
|
32.8 kg/m2
STANDARD_DEVIATION 7.3 • n=527 Participants
|
|
Indication for IOL
IUFD
|
10 Participants
n=527 Participants
|
20 Participants
n=1054 Participants
|
10 Participants
n=527 Participants
|
|
Indication for IOL
Emergency
|
4 Participants
n=527 Participants
|
9 Participants
n=1054 Participants
|
5 Participants
n=527 Participants
|
|
Nulliparity
|
5 Participants
n=527 Participants
|
10 Participants
n=1054 Participants
|
5 Participants
n=527 Participants
|
PRIMARY outcome
Timeframe: 12 hoursDelivery of fetus and placenta
Outcome measures
| Measure |
Simulatenous Mifepristone and Misoprostol
n=15 Participants
Participants will receive a dose of 200mg oral mifepristone at time of induction with misoprostol
|
Misoprostol Alone
n=14 Participants
Participants will have labor induced with misoprostol alone
|
|---|---|---|
|
Delivery Within 12 Hours
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 hoursDelivery of fetus and placenta
Outcome measures
| Measure |
Simulatenous Mifepristone and Misoprostol
n=15 Participants
Participants will receive a dose of 200mg oral mifepristone at time of induction with misoprostol
|
Misoprostol Alone
n=14 Participants
Participants will have labor induced with misoprostol alone
|
|---|---|---|
|
Delivery Within 24 Hours
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: During admissionTime from misoprostol to delivery of fetus and placenta
Outcome measures
| Measure |
Simulatenous Mifepristone and Misoprostol
n=15 Participants
Participants will receive a dose of 200mg oral mifepristone at time of induction with misoprostol
|
Misoprostol Alone
n=14 Participants
Participants will have labor induced with misoprostol alone
|
|---|---|---|
|
Time to Delivery
|
950 minutes
Standard Deviation 106
|
745 minutes
Standard Deviation 95
|
SECONDARY outcome
Timeframe: During admissionNeed for surgical evacuation of fetus via dilation and evacuation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During admissionNeed for surgical evacuation of placenta or membranes via dilation and curettage or manual vacuum aspiration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During admissionInfection within the uterus during labor induction as diagnosed by obstetrician
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During admissionBlood loss of greater than 1000mL or with hemodynamic instability
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysOutcome measures
Outcome data not reported
Adverse Events
Simulatenous Mifepristone and Misoprostol
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Misoprostol Alone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Simulatenous Mifepristone and Misoprostol
n=15 participants at risk
Participants will receive a dose of 200mg oral mifepristone at time of induction with misoprostol
|
Misoprostol Alone
n=14 participants at risk
Participants will have labor induced with misoprostol alone
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Composite morbidity
|
20.0%
3/15 • 30 days
|
35.7%
5/14 • 30 days
|
Additional Information
Katherine Bligard
Washington University School of Medicine
Phone: 2259542160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place