Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Outpatient cervical ripening with Foley Cervical ripening will begin with a Foley balloon in the outpatient setting |
Device: Outpatient Foley catheter
Outpatient Foley catheter placement for induction of labor
|
| No Intervention: Standard of care Inpatient cervical ripening Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent |
Outcome Measures
Primary Outcome Measures
- Incidence of Cesarean Delivery [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 Outcome Measures
- Maternal morbidity incidence [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
- Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R) [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
- Neonatal morbidity incidence [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, hypoglycemia or suspected sepsis
- Maternal patient perception of control [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
- Maternal overall length of stay [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
- Maternal postpartum length of stay [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
- Neonatal length of stay [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
- NICU admission [From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery]
Admission to neonatal intensive care unit
- NICU stay greater than 48 hours [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
Other Outcome Measures
- Heterogeneity of Treatment Effect/prespecified sub-groups [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)
Eligibility Criteria
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
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Vaginal bleeding or concern for/known abruption prior to Foley placement
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Chorioamnionitis
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Any fetal growth restriction
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Preeclampsia with severe features
-
Severe chronic hypertension
-
Type 1 diabetes or poorly controlled pre-gestational diabetes
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Sickle cell disease
-
Major fetal anomaly
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Women on therapeutic anticoagulation
-
Decreased fetal movement
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Christiana Care Health Services, Inc. | Newark | Delaware | United States | 19718 |
| 2 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 3 | University of Texas at Austin | Austin | Texas | United States | 78712 |
| 4 | University of Utah | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- University of Pennsylvania
Investigators
- Principal Investigator: Lisa Levine, MD, MSCE, University of Pennsylvaina
- Principal Investigator: Alison Cahill, MD, MSCI, University of Texas at Austin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 851906