Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Recruiting
N/A
Interventional Study
Induction of Labor Affected Fetus / Newborn
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 60
- Sex
- Female
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 2,300 (estimated)
- Sponsor
- University of Pennsylvania · Other
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About This Trial
A multicenter pragmatic randomized trial of nulliparous women undergoing a term (≥37 weeks) induction of labor wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing outpatient cervical ripening with a Foley catheter to routine inpatient cervical ripening (Foley +/- other method). With this trial, the investigators aim to test our central hy…
Trial Locations
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Eligibility Criteria
Inclusion Criteria
* Eligible for induction of labor
* Live singleton gestation ≥37 weeks and \<42 weeks
* Nulliparous, ≥18 years of age with no previous deliveries \>20 weeks
* Cephalic presentation
* Intact membranes
* Bishop score ≤8 and cervical dilation \<3 cm
* English or Spanish speaking (Ab…
Contacts