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NCT Number: NCT05759988

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

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.

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Key information

Conditions

Induction of Labor Affected Fetus / Newborn

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health Services, Inc., Newark, Delaware, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outpatient Foley catheter

Device

Outpatient Foley catheter placement for induction of labor

Primary outcomes

  1. Incidence of Cesarean Delivery

    Time frame: At delivery

    Incidence of cesarean delivery in women randomized to outpatient cervical ripening with the Foley catheter compared to women undergoing routine inpatient cervical ripening

Secondary outcomes

  1. Maternal morbidity incidence

    Time frame: Within 6 weeks of delivery

    Defined as a composite endpoint consisting of at least one occurrence of the following outcomes: postpartum hemorrhage, blood transfusion, endometritis, wound/laceration breakdown or infection, venous thromboembolis and hospital readmission with 6 weeks

  2. 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

    Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction

  3. Neonatal morbidity incidence

    Time frame: Within 6 weeks of delivery

    Defined as a composite endpoint consisting of at least one incidence of the following outcomes: acidemia, respiratory failure/insufficiency, hypoxic-ischemic encephalopathy, treatment for hypoglycemia or suspected sepsis

  4. Maternal patient perception of control

    Time frame: From time of delivery to discharge from hospital, up to 6 weeks from delivery

    Measured by the Labour Agentry Scale (LAS), as 29-item questionnaire with higher values reflecting a higher measure of perceived personal control

  5. Maternal overall length of stay

    Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery

    Measured by hours from admission to postpartum discharge

  6. Maternal postpartum length of stay

    Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery

    Measured by hours from delivery to postpartum discharge

  7. Neonatal length of stay

    Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery

    Length of stay from birth to discharge, measured in hours

  8. NICU admission

    Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery

    Admission to neonatal intensive care unit

  9. 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

    Admission to the NICU for more than 48 hours

  10. Perceived stress scale-10 questions

    Time frame: From time of delivery to discharge from hospital, up to 6 weeks from delivery

    A validated 10 question scale evaluating perceived stress

Other outcomes

  1. Heterogeneity of Treatment Effect/prespecified sub-groups

    Time frame: within 6 weeks of delivery

    Pre-specified subgroups to be included are: Starting cervical dilation (<1cm vs. >=1cm), Bishop score (<6 vs. >=6), BMI (<30 kg/m2 vs. >=30 kg/m2), Race/ethnicity (Black, White, Asian, Other; Hispanic/Non-Hispanic), Gestational age at start of induction (37-39w6d vs. >=40 weeks), Advanced Maternal Age (AMA) (>=35 yo) vs not AMA (<35 yo)

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Levine, MD, MSCE

CONTACT

[email protected]

215-283-7373

Meaghan McCabe, MPH

CONTACT

[email protected]

215-283-7373

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: COMFORT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 8, 2023
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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