Phase 4
Completed N=30
Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial
Abortion, Second Trimester · PPROM · Rupture, Spontaneous · Fetal Demise
Source: ClinicalTrials.gov NCT05322252 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Delivery Within 12 Hours — 5; 5 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
When time allows, administration of mifepristone prior to second trimester induction of labor decreases total labor time. However, in the setting of many pregnancy complications, decreasing time from diagnosis of nonviable pregnancy to delivery is of utmost importance to decrease risk of maternal complications. Previous data has shown that total abortion time is longer in the group receiving mifepristone owing to the delay between mifepristone administration and initiation of misoprostol induction of labor. Thus, the investigators aim to investigate whether simultaneous mifepristone and misoprostol has benefits over misoprostol alone when labor induction of a nonviable second trimester cannot be delayed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delivery Within 12 Hours |
5; 5 | — |
| SECONDARY Delivery Within 24 Hours |
12; 13 | — |
| SECONDARY Time to Delivery |
950; 745 | — |
| SECONDARY Failed Induction of Labor |
— | — |
| SECONDARY Retained Placenta |
— | — |
| SECONDARY Diagnosis of Clinical Chorioamnionitis |
— | — |
| SECONDARY Postpartum Hemorrhage |
— | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- 14 and 28 weeks' gestation
- Singleton gestation
- Nonviable fetus (i.e. fetal demise or previable gestational age/weight or lethal fetal anomaly)
- Requires induction of labor
- If fetal cardiac motion, abortion being performed for medical emergency per MO laws and consents completed
Exclusion Criteria
- Contraindication to mifepristone
- Plan for surgical evacuation of uterus
- Contraindication to vaginal delivery
- Plan to initiate induction with any medication or device except misoprostol
- Declines participation
Data sourced from ClinicalTrials.gov (NCT05322252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.