Induction of Labor Affected Fetus / NewbornCOMFORTNCT05759988
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
A study testing Outpatient Foley catheter in people with Induction of Labor Affected Fetus / Newborn, run by University of Pennsylvania at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Outpatient Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Apr 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Texas at Austin
Austin, Texas, 78712
Brooke lasher, brooke.lasher@austin.utexas.edu
Alison G Cahill, MD, MSCI
- Recruiting
Christiana Care Health Services, Inc.
Newark, Delaware, 19718
Carrie Kitto, ckitto@christianacare.org
Amy Staples, amy.staples@christianacare.org
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Naeemah Turner, naeemah.turner@pennmedicine.upenn.edu
Meaghan McCabe, MPH, meaghan.mccabe@pennmedicine.upenn.edu
- Recruiting
Princeton Medical Center
Plainsboro, New Jersey, 08536
Naeemah Turner, naeemah.turner@pennmedicine.upenn.edu
Lisa D Levine, MD, MSCE
- Recruiting
Intermountain Health Utah Valley Hospital
Provo, Utah, 84604
Stacey Breeze, 801-507-7433, stacey.breeze@imail.org
Jessica Page, MD
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Stephen Forsyth, stephen.forsyth@hsc.utah.edu
Robert M Silver, MD
About this study
Official title: Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
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.
- Being tested
- Outpatient Foley catheter
- Keywords
- Foley balloon catheter, Outpatient cervical ripening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Foley catheterDevice
Outpatient Foley catheter placement for induction of labor
| Study group | Role | What they receive |
|---|---|---|
| Outpatient cervical ripening with Foley | Experimental | Cervical ripening will begin with a Foley balloon in the outpatient setting Receives: Device: Outpatient Foley catheter |
| Standard of care Inpatient cervical ripening | No intervention | Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Cesarean Delivery
Incidence of cesarean delivery in women randomized to outpatient cervical ripening with the Foley catheter compared to women undergoing routine inpatient cervical ripening
Measured: At delivery
Secondary outcomes (10)
Maternal morbidity incidence
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
Measured: Within 6 weeks of delivery
Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)
Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction
Measured: From time of delivery to discharge from hospital, up to 6 weeks from delivery
Neonatal morbidity incidence
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
Measured: Within 6 weeks of delivery
Maternal patient perception of control
Measured by the Labour Agentry Scale (LAS), as 29-item questionnaire with higher values reflecting a higher measure of perceived personal control
Measured: From time of delivery to discharge from hospital, up to 6 weeks from delivery
Maternal overall length of stay
Measured by hours from admission to postpartum discharge
Measured: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Maternal postpartum length of stay
Measured by hours from delivery to postpartum discharge
Measured: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Neonatal length of stay
Length of stay from birth to discharge, measured in hours
Measured: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
NICU admission
Admission to neonatal intensive care unit
Measured: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
NICU stay greater than 48 hours
Admission to the NICU for more than 48 hours
Measured: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Perceived stress scale-10 questions
A validated 10 question scale evaluating perceived stress
Measured: From time of delivery to discharge from hospital, up to 6 weeks from delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start13 Apr 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Levine, University of Pennsylvania
- Investigators
- Lisa Levine, MD, MSCE, Principal investigator, University of PennsylvainaAlison Cahill, MD, MSCI, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759988
- Sponsor's protocol ID
- 851906
- Acronym
- COMFORT
- Status last verified
- Jan 2026
- First submitted
- 14 Feb 2023
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05759988
- Acronym / sponsor ID
- COMFORT / 851906
- Keywords
- Foley balloon catheter, Outpatient cervical ripening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient cervical ripening with Foley | Experimental | Device: Outpatient Foley catheterCervical ripening will begin with a Foley balloon in the outpatient setting |
| Standard of care Inpatient cervical ripening | No intervention | –Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient Foley catheterOutpatient Foley catheter placement for induction of labor | Device | Outpatient cervical ripening with Foley |
Primary outcome
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Levine, MD, MSCE principal investigator
University of Pennsylvaina
Alison Cahill, MD, MSCI principal investigator
University of Texas at Austin
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient Foley catheter in people with Induction of Labor Affected Fetus / Newborn, run by University of Pennsylvania at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Levine, MD, MSCE (215-283-7373, lisa.levine@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Cesarean Delivery (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.