Outpatient cervical ripening using a Foley catheter

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter pragmatic randomized trial focuses on nulliparous women who are eligible for induction of labor at term. It compares the effectiveness of outpatient cervical ripening using a Foley catheter against the traditional inpatient method. The primary goal is to determine if outpatient use of the Foley catheter can reduce the rate of Cesarean deliveries and lower maternal and neonatal morbidity. Participants will be monitored closely to ensure safety and efficacy throughout the process.

Why it matters

Who can join: the full rules

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

Where it's running

• Christiana Care Health Services, Inc.
  Newark, Delaware, United States Recruiting
• Princeton Medical Center
  Plainsboro, New Jersey, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• University of Texas at Austin
  Austin, Texas, United States Recruiting
• Intermountain Health Utah Valley Hospital
  Provo, Utah, United States Recruiting
• University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Lisa Levine, MD, MSCE — University of Pennsylvaina
• Study coordinator: Lisa Levine, MD, MSCE
• Email: lisa.levine@pennmedicine.upenn.edu
• Phone: 215-283-7373

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.