Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2023-06-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Labor Induction Early Amniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early amniotomy

Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon.

Group Type EXPERIMENTAL

Amniotomy

Intervention Type PROCEDURE

Artificial rupture of amniotic membranes

Foley balloon

Intervention Type DEVICE

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.

Delayed amniotomy

Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon.

Group Type ACTIVE_COMPARATOR

Amniotomy

Intervention Type PROCEDURE

Artificial rupture of amniotic membranes

Foley balloon

Intervention Type DEVICE

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.

Interventions

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Amniotomy

Artificial rupture of amniotic membranes

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Other Intervention Names

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Foley catheter Foley bulb

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No