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N/A N=150 Randomized Treatment

Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor

Labor Induction · Early Amniotomy

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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