Pregnancy Complications Clinical Trial
— MISTOfficial title:
Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pregnancy related readmission within 30 days | 30 days | ||
Primary | Delivery within 12 hours | Delivery of fetus and placenta | 12 hours | |
Secondary | Delivery within 24 hours | Delivery of fetus and placenta | 24 hours | |
Secondary | Time to delivery | Time from misoprostol to delivery of fetus and placenta | During admission | |
Secondary | Failed induction of labor | Need for surgical evacuation of fetus via dilation and evacuation | During admission | |
Secondary | Retained placenta | Need for surgical evacuation of placenta or membranes via dilation and curettage or manual vacuum aspiration | During admission | |
Secondary | Diagnosis of clinical chorioamnionitis | Infection within the uterus during labor induction as diagnosed by obstetrician | During admission | |
Secondary | Postpartum hemorrhage | Blood loss of greater than 1000mL or with hemodynamic instability | During admission |
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