Phase
Condition
N/ATreatment
Outpatient Foley catheter
Clinical Study ID
Ages 18-60 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Connect with a study center
Christiana Care Health Services, Inc.
Newark, Delaware 19718
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Texas at Austin
Austin, Texas 78712
United StatesActive - Recruiting
University of Utah
Salt Lake City, Utah 84112
United StatesActive - Recruiting
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