Outpatient cervical ripening using a Foley catheter
Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
This study is testing if using a Foley catheter at home to help prepare the cervix for labor can reduce the need for C-sections and improve safety for first-time moms and their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2300 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 6 sites (Newark, Delaware and 5 other locations) |
| Trial ID | NCT05759988 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are nulliparous women aged 18 and older, with a live singleton pregnancy at term, who meet specific medical criteria for outpatient cervical ripening.
Not a fit: Patients with certain complications such as oligohydramnios, severe polyhydramnios, or other significant maternal or fetal health concerns may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more efficient labor induction for women, reducing the need for Cesarean deliveries.
How similar studies have performed: Other studies have shown promising results with outpatient cervical ripening methods, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newark, Delaware and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.