Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
- Conditions
- Induction of Labor Affected Fetus / Newborn
- Registration Number
- NCT05759988
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria<br><br> - Eligible for induction of labor<br><br> - Live singleton gestation =37 weeks and <42 weeks<br><br> - Nulliparous, =18 years of age with no previous deliveries >20 weeks<br><br> - Cephalic presentation<br><br> - Intact membranes<br><br> - Bishop score =8 and cervical dilation <3 cm<br><br> - English or Spanish speaking (Able to read/understand consent and instructions)<br><br> - Have reliable transportation to get back to the hospital and have a self-reported<br> safe residence to go home to with the Foley catheter<br><br>Exclusion Criteria<br><br> - Known oligohydramnios (DVP <2cm)<br><br> - Known moderate-severe polyhydramnios (AFI =30 at time of delivery)<br><br> - Concern regarding fetal status during antenatal testing: At provider discretion, but<br> includes fetal decelerations, biophysical profile =6/10<br><br> - Vaginal bleeding or concern for/known abruption prior to Foley placement<br><br> - Chorioamnionitis<br><br> - Any fetal growth restriction<br><br> - Preeclampsia with severe features<br><br> - Severe chronic hypertension<br><br> - Type 1 diabetes or poorly controlled pre-gestational diabetes<br><br> - Sickle cell disease<br><br> - Major fetal anomaly<br><br> - Women on therapeutic anticoagulation<br><br> - Decreased fetal movement<br><br> - HIV Positive (rationale: HIV positive patients require an IV medication at the start<br> of labor induction which cannot be given as an outpatient. There is universal<br> testing of HIV in the 3rd trimester to verify this exclusion criteria)<br><br> - Maternal cardiac disease requiring telemetry monitoring throughout induction/labor<br> course
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Cesarean Delivery
- Secondary Outcome Measures
Name Time Method Maternal morbidity incidence;Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R);Neonatal morbidity incidence;Maternal patient perception of control;Maternal overall length of stay;Maternal postpartum length of stay;Neonatal length of stay;NICU admission;NICU stay greater than 48 hours;Perceived stress scale-10 questions