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Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)

RecruitingNAAges 18 Years - 60 YearsFemaleUniversity of Pennsylvania
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In plain words

What the trial is, and whether it could suit you

A multicenter pragmatic randomized trial of nulliparous women undergoing a term (โ‰ฅ37 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria * Eligible for induction of labor * Live singleton gestation โ‰ฅ37 weeks and \<42 weeks * Nulliparous, โ‰ฅ18 years of age with no previous deliveries \>20 weeks * Cephalic presentation * Intact membranes * Bishop score โ‰ค8 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 โ‰ฅ30 at time of delivery) * Concern regarding fetal status during antenatal testing: At provider discretion, but includes fetal decelerations, biophysical profile โ‰ค6/10 * 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
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What it tests

  • Outpatient Foley catheter
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Where

6 sites
Christiana Care Health Services, Inc.
Newark, United States
Princeton Medical Center
Plainsboro, United States
University of Pennsylvania
Philadelphia, United States
University of Texas at Austin
Austin, United States
Intermountain Health Utah Valley Hospital
Provo, United States
University of Utah
Salt Lake City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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