Clinical trial NCT03039036: Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
Official title: A Randomized Clinical Trial of Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Induction
Keywords: Labor Induction
Early Amniotomy
Foley catheter
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least 4 hours after Foley catheter removal). Other aims include the relationship between timing of amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar score \<7 at 5 minutes, neonatal need for intensive care.

The investigators hypothesize that induction of labor with Foley catheters followed by early amniotomy will result in a decreased duration of labor compared to those who undergo delayed amniotomy.

Detailed description: This randomized clinical trial of consenting nulliparous women undergoing induction of labor with a Foley catheter seeks to determine whether use of early amniotomy (defined as amniotomy within 1 hour of Foley catheter removal) improves obstetrical outcomes when compared with delayed amniotomy (defined as amniotomy at least 4 hours following Foley catheter removal).

This project will include 110 women recruited from the obstetrical service at Prentice Women's Hospital. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter. Following removal of Foley catheter, women will be assessed for safety of amniotomy and if appropriate, randomized to either early amniotomy or delayed amniotomy.

Women will be randomized with equal probability to the intervention group using block randomization stratified by use of Foley catheter alone or Foley catheter-misoprostol use.

Women in the early amniotomy group will undergo amniotomy within 1 hour of Foley catheter removal. Women in the delayed amniotomy group will undergo amniotomy at least 4 hours following Foley removal. The remainder of labor management will be at the discretion of each woman's obstetric provider.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review

Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* English speaking
* Women age 18 years old or greater
* Nulliparous
* Pregnant with a singleton gestation that is greater than or equal to 37 weeks
* Undergoing induction of labor with Foley catheter

Exclusion Criteria:

* Women not meeting above criteria
* Fetus in non-cephalic position
* Intrauterine fetal demise
* Fetus with major anomalies
* HIV, hepatitis B or C infection
* Planned use of oxytocin during the Foley catheter ripening

Primary outcomes:
measure: Time interval from Foley catheter removal to delivery
timeFrame: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
Secondary outcomes:
measure: Cesarean delivery
timeFrame: At time of delivery
measure: Chorioamnionitis
timeFrame: From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours
measure: Postpartum Fever
timeFrame: From time of delivery to time of hospital discharge; up to 6 weeks
measure: Wound infection
timeFrame: From time of delivery to time of hospital discharge; up to 6 weeks
measure: Endometritis
timeFrame: From time of delivery to time of hospital discharge; up to 6 weeks
measure: 5 minute Apgar Score less than 7 out of 10
timeFrame: 5 minutes following delivery; 5 minutes of neonatal life.
measure: Neonatal intensive care unit admission
timeFrame: From time of delivery to hospital discharge; up to 6 weeks
measure: Length of Labor
timeFrame: Time from placement of Foley catheter to time of delivery of neonate; up to 5 days
measure: Suspected or confirmed neonatal sepsis
timeFrame: From time of delivery to hospital discharge; up to 6 weeks
measure: Postpartum hemorrhage
timeFrame: From time of delivery to time of hospital discharge; up to 6 weeks
measure: Delivery time less than 24 hours
timeFrame: From time of placement of Foley catheter to time of delivery of neonate; within 24 hours.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Emily Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
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