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

Induction of Labor Affected Fetus / Newborn Clinical Trial

— COMFORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759988
• Other study ID #: 851906
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: Lisa Levine, MD, MSCE
• Phone: 215-283-7373
• Email: lisa.levine[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas
United States	Christiana Care Health Services, Inc.	Newark	Delaware
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heterogeneity of Treatment Effect/prespecified sub-groups	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)	within 6 weeks of delivery
Primary	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	At delivery
Secondary	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	Within 6 weeks of delivery
Secondary	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	From time of delivery to discharge from hospital, up to 6 weeks from delivery
Secondary	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	Within 6 weeks of delivery
Secondary	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	From time of delivery to discharge from hospital, up to 6 weeks from delivery
Secondary	Maternal overall length of stay	Measured by hours from admission to postpartum discharge	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Secondary	Maternal postpartum length of stay	Measured by hours from delivery to postpartum discharge	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Secondary	Neonatal length of stay	Length of stay from birth to discharge, measured in hours	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Secondary	NICU admission	Admission to neonatal intensive care unit	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Secondary	NICU stay greater than 48 hours	Admission to the NICU for more than 48 hours	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Secondary	Perceived stress scale-10 questions	A validated 10 question scale evaluating perceived stress	From time of delivery to discharge from hospital, up to 6 weeks from delivery