Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb
Completed · Early Phase 1
Conditions studied: Induction of Labor
In brief
Combined misoprostol and Foley bulb catheter has been shown to be an effective induction method. However, optimal route of administration for misoprostol has not been established. Therefore, the purpose of this study is to compare the effectiveness and safety of combination buccal miso-foley to combination vaginal miso-foley for third trimester cervical ripening and induction of labor.
Key facts
- Study ID
- NCT03976037
- Run by
- Christiana Care Health Services
- People needed
- 216
- Starts
- 2019-06-04
- Expected to finish
- 2021-02-01
- Last updated by the study team
- 2021-02-26
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- ≥18 years of age
- full term (≥37 weeks) gestations determined by routine obstetrical guidelines
- singleton gestation in cephalic presentation
- Both nulliparous and multiparous women
- Intact membranes
- Cervical dilation ≤2cm
You may not qualify if…
- Any contraindication to a vaginal delivery or to misoprostol
- fetal demise
- Multifetal gestation
- prior uterine surgery, previous cesarean section
- Tachysystole was defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods
- women with HIV, and women with medical conditions requiring an assisted second stage
- Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies
- As described in previous research (Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016;128(6):1357-1364)
Where it is running
- Christiana Care Health Systems — Newark, Delaware, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.