Labor Induction, Cesarean Delivery
Conditions
Keywords
Labor, Induction, Cesarean, TOLAC, Foley, Oxytocin
Brief summary
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.
Interventions
DEVICEFoley balloon
Foley balloon for induction of labor
DRUGOxytocin
Pitocin for induction of labor
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible for induction of labor * Live singleton gestation ≥37 weeks * History of 1 cesarean delivery * ≥18 years of age * Cephalic presentation * Intact membranes * English or Spanish speaking (Able to read/understand consent and instructions) * Cervical dilation \<3cm and Bishop score \<8
Exclusion criteria
* \>1 prior Cesarean delivery * Known chorioamnionitis * Major fetal anomaly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to delivery | At delivery | The primary endpoint will be time from start of induction until delivery (hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum hemorrhage | Within 6 weeks of delivery | Estimated blood loss≥ 1L |
| Number of Participants with Chorioamnionitis | At delivery | Documented chorioamnionitis |
| Mode of delivery | At delivery | Successful vaginal birth after cesarean (VBAC) or repeat cesarean delivery (rCD) |
| Number of Participants with Uterine Rupture | At delivery | Uterine rupture noted at the time of cesarean delivery |
| Maternal morbidity | 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 thromboembolism and hospital readmission with 6 weeks |
| Estimated postpartum blood loss | At delivery | Estimated postpartum blood loss in mL |
| Maternal 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 |
| 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 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 |
| 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 | Within 6 weeks of delivery | Defined as neonatal resuscitation requiring supplemental oxygen outside of the delivery room for at least 12 hours of culture proven/presumed neonatal sepsis |
Countries
United States
Contacts
Primary ContactHannah Foster, MD, MAUB
Outcome results
None listed