A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor
Completed · Not applicable
Conditions studied: Pregnancy
In brief
A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb together with vaginal misoprostol will result in shorter induction to delivery time compared with vaginal misoprostol alone
Key facts
- Study ID
- NCT02566005
- Run by
- St. Luke's-Roosevelt Hospital Center
- People needed
- 200
- Starts
- 2015-09-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2018-03-27
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Term 37 weeks or more, singleton in cephalic presentation
- Age 18 years and older
- Patient admitted for induction of labor
You may not qualify if…
- Malpresentation
- Preterm labor less than 37 weeks of gestation
- Patients with fetal anomalies
- Premature rupture of membranes
- If the cervix is closed and unable to place the foley bulb
- Multiple gestation
- Non-reassuring fetal heart tracing
- Contraindication to misoprostol
- Contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, marginal previa, macrosomia, etc). History of prior uterine surgery such as cesarean section or myomectomy
Where it is running
- Mount Sinai Roosevelt — New York, New York, United States
Full record on ClinicalTrials.gov
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