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

Launched by UNIVERSITY OF PENNSYLVANIA · Mar 7, 2023

Keywords

ClinConnect Summary

The COMFORT trial is studying a method for preparing a woman's body for labor called cervical ripening, using a Foley catheter. This trial is looking at whether this procedure can be done safely at home (outpatient) instead of in a hospital (inpatient). The goal is to see if using the Foley catheter at home can lower the chances of needing a Cesarean delivery and reduce risks for the mother and baby compared to doing it in the hospital.

To participate in this study, women must be at least 18 years old, pregnant for at least 37 weeks, and having their first baby. They should also be in good health, with a few specific medical conditions ruled out, and be able to understand instructions in English or Spanish. Participants can expect to receive the Foley catheter and then return home for a short period before coming back to the hospital for labor. It's important for them to have reliable transportation and a safe place to go home to during this time.

Gender

FEMALE

Eligibility criteria

• • 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