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Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)

University of Pennsylvania · NCT05759988

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–60 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
2300
US sites recruiting
6
Study start
April 13, 2023
Record last updated
February 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 hypothesis that outpatient Foley will decrease the primary Cesarean Delivery (CD) rate and risk of maternal/neonatal morbidity compared with inpatient cervical ripening.

Being studied: Outpatient Foley catheter

Conditions: Induction of Labor Affected Fetus / Newborn

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 (Able to read/understand consent and instructions)
  • Have reliable transportation to get back to the hospital and have a self-reported safe residence to go home to with the Foley catheter

Exclusion Criteria

  • Known oligohydramnios (DVP \<2cm)
  • Known moderate-severe polyhydramnios (AFI ≥30 at time of delivery)
  • Concern regarding fetal status during antenatal testing: At provider discretion, but includes fetal decelerations, biophysical profile ≤6/10
  • Vaginal bleeding or concern for/known abruption prior to Foley placement
  • Chorioamnionitis
  • Any fetal growth restriction
  • Preeclampsia with severe features
  • Severe chronic hypertension
  • Type 1 diabetes or poorly controlled pre-gestational diabetes
  • Sickle cell disease
  • Major fetal anomaly
  • Women on therapeutic anticoagulation
  • Decreased fetal movement
  • HIV Positive (rationale: HIV positive patients require an IV medication at the start of labor induction which cannot be given as an outpatient. There is universal testing of HIV in the 3rd trimester to verify this exclusion criteria)
  • Maternal cardiac disease requiring telemetry monitoring throughout induction/labor course

Recruiting US locations

  • Christiana Care Health Services, Inc.

    Newark, DE 19718

    Site contact: Carrie Kitto · ckitto@christianacare.org

  • Princeton Medical Center

    Plainsboro, NJ 08536

    Site contact: Naeemah Turner · naeemah.turner@pennmedicine.upenn.edu

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Naeemah Turner · naeemah.turner@pennmedicine.upenn.edu

  • University of Texas at Austin

    Austin, TX 78712

    Site contact: Brooke lasher · brooke.lasher@austin.utexas.edu

  • Intermountain Health Utah Valley Hospital

    Provo, UT 84604

    Site contact: Stacey Breeze · 801-507-7433 · stacey.breeze@imail.org

  • University of Utah

    Salt Lake City, UT 84112

    Site contact: Stephen Forsyth · stephen.forsyth@hsc.utah.edu

Study contacts (from the official record)

  • Lisa Levine, MD, MSCE · 215-283-7373 · lisa.levine@pennmedicine.upenn.edu
  • Meaghan McCabe, MPH · 215-283-7373 · meaghan.mccabe@pennmedicine.upenn.edu
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Cervical Ripening as an Outpatient Method Using the Foley (COMFORT) (NCT05759988) | Bored Studies