NCT05759988 · University of Pennsylvania
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
(COMFORT)
What this study is about
A conducted at multiple hospitals pragmatic randomly assigned 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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Newark, Delaware
- Plainsboro, New Jersey
- Philadelphia, Pennsylvania
- Austin, Texas
- Provo, Utah
- Salt Lake City, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2026 · Source of record for eligibility and locations