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.
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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

Lisa Levine, MD, MSCE

215-283-7373

lisa.levine@pennmedicine.upenn.edu

CONTACT

Meaghan McCabe, MPH

215-283-7373

meaghan.mccabe@pennmedicine.upenn.edu

CONTACT