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Recruiting NCT05759988

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

No phase Interventional Induction of Labor Affected Fetus / Newborn

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Outpatient Foley catheter.
Who it may be relevant to
Registry conditions: Induction of Labor Affected Fetus / Newborn. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial

Overview

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). 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.

Interventions

  • Device Outpatient Foley catheter
    Outpatient Foley catheter placement for induction of labor

Primary outcome measures

  • Incidence of Cesarean Delivery [Time frame: At delivery]
Secondary outcome measures (10)
  • Maternal morbidity incidence [Time frame: Within 6 weeks of delivery]
  • Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R) [Time frame: From time of delivery to discharge from hospital, up to 6 weeks from delivery]
  • Neonatal morbidity incidence [Time frame: Within 6 weeks of delivery]
  • Maternal patient perception of control [Time frame: From time of delivery to discharge from hospital, up to 6 weeks from delivery]
  • Maternal overall length of stay [Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery]
  • Maternal postpartum length of stay [Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery]
  • Neonatal length of stay [Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery]
  • NICU admission [Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery]
  • NICU stay greater than 48 hours [Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery]
  • Perceived stress scale-10 questions [Time frame: From time of delivery to discharge from hospital, up to 6 weeks from delivery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 6 centers
  • Christiana Care Health Services, Inc. — Newark
  • Princeton Medical Center — Plainsboro
  • University of Pennsylvania — Philadelphia
  • University of Texas at Austin — Austin
  • Intermountain Health Utah Valley Hospital — Provo
  • University of Utah — Salt Lake City

Identifiers

NCT: NCT05759988 · 851906

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗