A randomized trial of patients undergoing a term (≥37 weeks) induction of labor with a history of one prior Cesarean delivery, wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing Foley alone with concurrent Foley and Oxytocin use at the start of the induction. With this trial, the investigators aim to test our central hypothesis that concurrent Foley and Oxytocin will decrease time to delivery without increasing risks, compared to Foley alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Foley balloon for induction of labor
Pitocin for induction of labor
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGTime to delivery
The primary endpoint will be time from start of induction until delivery (hours)
Time frame: At delivery
Estimated postpartum blood loss
Estimated postpartum blood loss in mL
Time frame: At delivery
Postpartum hemorrhage
Estimated blood loss≥ 1L
Time frame: Within 6 weeks of delivery
Number of Participants with Chorioamnionitis
Documented chorioamnionitis
Time frame: At delivery
Mode of delivery
Successful vaginal birth after cesarean (VBAC) or repeat cesarean delivery (rCD)
Time frame: At delivery
Number of Participants with Uterine Rupture
Uterine rupture noted at the time of cesarean delivery
Time frame: At delivery
Maternal morbidity
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 thromboembolism and hospital readmission with 6 weeks
Time frame: Within 6 weeks of delivery
Neonatal morbidity
Defined as neonatal resuscitation requiring supplemental oxygen outside of the delivery room for at least 12 hours of culture proven/presumed neonatal sepsis
Time frame: Within 6 weeks of delivery
Maternal length of stay
Measured by hours from admission to postpartum discharge
Time frame: 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
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
Admission to the NICU for more than 48 hours
Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from 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
Time frame: From time of delivery to discharge from hospital, up to 6 weeks from delivery
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