Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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 <3%
  • EFW > 4200 g
  • Fetal demise or major congenital anomaly
  • Prisoners

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Early amniotomy
Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon.
  • Procedure: Amniotomy
    Artificial rupture of amniotic membranes
  • Device: Foley balloon
    The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.
    Other names:
    • Foley catheter
    • Foley bulb
Active Comparator
Delayed amniotomy
Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon.
  • Procedure: Amniotomy
    Artificial rupture of amniotic membranes
  • Device: Foley balloon
    The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.
    Other names:
    • Foley catheter
    • Foley bulb

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77550
Contact:
Elizabeth Welch
409-747-6622
elwelch@utmb.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Marissa Berry, MD
4097474952
majberry@utmb.edu

Detailed Description

This will be an unblinded randomized clinical trial. The investigators will recruit 174 pregnant women undergoing induction of labor. Recruitment will occur on the Labor and Delivery unit at the time of induction, after the decision has been made to place a Foley balloon for cervical ripening. Enrolled subjects will be randomized to early or delayed amniotomy.

Subjects randomized to early amniotomy will undergo amniotomy within 2 hours of Foley balloon removal. Subjects randomized to delayed amniotomy will undergo amniotomy at least 4 hours after Foley balloon removal.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.