N/A
N=150
Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor
Labor Induction · Early Amniotomy
Bottom Line
View on ClinicalTrials.gov: NCT04573517 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Time to Active Phase of Labor — 885; 975 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amniotomy (Procedure); Foley balloon (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Active Phase of Labor |
885; 975 | — |
| SECONDARY Time to Delivery |
— | — |
| SECONDARY Vaginal Delivery Rate |
— | — |
| SECONDARY Cesarean Section Rate |
— | — |
| SECONDARY Maternal Infection Composite |
— | — |
| SECONDARY Umbilical Cord Prolapse |
— | — |
| SECONDARY Neonatal Outcome Composite |
— | — |
Summary
Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.
Eligibility Criteria
Inclusion Criteria
- Age 18
- Singleton pregnancy
- Term gestation (37 weeks gestation)
- Cephalic presentation
- Undergoing labor induction with transcervical Foley balloon
Exclusion Criteria
- Previous uterine surgery
- Prelabor rupture of membranes
- Severe pre-eclampsia, HELLP, or eclampsia
- HIV, HCV, or HBV
- Heart disease
- Fever (≥38 0C) at admission
- Category II or III fetal heart rate tracing prior to randomization
- Polyhydramnios
- Fetal growth restriction 4200 g
- Fetal demise or major congenital anomaly
- Prisoners
Data sourced from ClinicalTrials.gov (NCT04573517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.