Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | September 12, 2017 |
| End Date: | July 1, 2021 |
| Contact: | Nevert Badreldin, MD |
| Email: | nevert.badreldin@northwestern.edu |
| Phone: | 3124724648 |
A Randomized Clinical Trial of Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
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.
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.
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
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
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
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