Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient cervical ripening with Foley | Experimental | Cervical 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient Foley catheter | Device | Outpatient Foley catheter placement for induction of labor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Levine, MD, MSCE | Contact | 215-283-7373 | lisa.levine@pennmedicine.upenn.edu | |
| Meaghan McCabe, MPH | Contact | 215-283-7373 | meaghan.mccabe@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Levine, MD, MSCE | University of Pennsylvaina | Principal Investigator |
| Alison Cahill, MD, MSCI | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health Services, Inc. | Recruiting | Newark | Delaware | 19718 | United States |
Not provided
To be determined
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Outcome assessor will be blinded to the group allocation
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Princeton Medical Center | Recruiting | Plainsboro | New Jersey | 08536 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| University of Texas at Austin | Recruiting | Austin | Texas | 78712 | United States |
|
| Intermountain Health Utah Valley Hospital | Recruiting | Provo | Utah | 84604 | United States |
|
| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
|