NCT05759988 Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
| NCT ID | NCT05759988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Induction of Labor Affected Fetus / Newborn |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,300 participants |
| Start Date | 2023-04-13 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,300 participants in total. It began in 2023-04-13 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 (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
Contact & Investigator
Lisa Levine, MD, MSCE
PRINCIPAL INVESTIGATOR
University of Pennsylvaina
Frequently Asked Questions
Who can join the NCT05759988 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Induction of Labor Affected Fetus / Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05759988 currently recruiting?
Yes, NCT05759988 is actively recruiting participants. Contact the research team at lisa.levine@pennmedicine.upenn.edu for enrollment information.
Where is the NCT05759988 trial being conducted?
This trial is being conducted at Newark, United States, Plainsboro, United States, Philadelphia, United States, Austin, United States and 2 additional locations.
Who is sponsoring the NCT05759988 clinical trial?
NCT05759988 is sponsored by University of Pennsylvania. The principal investigator is Lisa Levine, MD, MSCE at University of Pennsylvaina. The trial plans to enroll 2,300 participants.