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New treatment option for Induction of Labor Affected Fetus / Newborn
Official title Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
ClinicalTrials.gov ID: NCT05759988
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- Maternal cardiac disease requiring telemetry monitoring throughout induction/labor course
The study team makes the final eligibility decision.
Where it's taking place
- Newark, Delaware, United States
- Plainsboro, New Jersey, United States
- Philadelphia, Pennsylvania, United States
- Austin, Texas, United States
- Provo, Utah, United States
- Salt Lake City, Utah, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, Delaware, United States; Plainsboro, New Jersey, United States; Philadelphia, Pennsylvania, United States; Austin, Texas, United States; Provo, Utah, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.