Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
- Conditions
- Labor Induction
- Interventions
- Registration Number
- NCT03039036
- Lead Sponsor
- Northwestern University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 69
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Amniotomy Amniotomy Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy within 1 hour of Foley catheter removal. Early Amniotomy Foley Catheter Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy within 1 hour of Foley catheter removal. Delayed Amniotomy Amniotomy Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy no sooner than 4 hours following removal of Foley catheter. Delayed Amniotomy Foley Catheter Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy no sooner than 4 hours following removal of Foley catheter. Delayed Amniotomy Misoprostol Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy no sooner than 4 hours following removal of Foley catheter. Early Amniotomy Misoprostol Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy within 1 hour of Foley catheter removal.
- Primary Outcome Measures
Name Time Method Time interval from Foley catheter removal to delivery Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours. Hours
- Secondary Outcome Measures
Name Time Method Cesarean delivery At time of delivery binary; yes/no
Chorioamnionitis From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours Maternal Temperature of \>/= 39 degrees Celsius or \>/= 38 degrees Celsius on two occasions greater than 30 minutes apart and at least one of the following: Fetal tachycardia (defined as sustained (\>10 min) fetal heart rate \>160), White Bood Cell Count \>15, purulent fluid from cervical os, or receipt of antibiotics and diagnosis written in the chart
Postpartum Fever From time of delivery to time of hospital discharge; up to 6 weeks Temperature \>/= 38 degrees celsius on 2 separate occasions greater than 6 hours apart
Wound infection From time of delivery to time of hospital discharge; up to 6 weeks Cellulitis or erythema and induration around the incision and purulent discharge from the incision site with or without fever
Endometritis From time of delivery to time of hospital discharge; up to 6 weeks fundal tenderness and fever that required treatment with antibiotics
5 minute Apgar Score less than 7 out of 10 5 minutes following delivery; 5 minutes of neonatal life. Neonatal Apgar scores consist of measurements of neonatal skin color, respiratory rate, heart rate, muscle tone, and irritability. Each parameter is given a score of 0, 1 or 2 based on standardized parameters. It is standard to perform this on all neonates at 1 minute and 5 minutes of life. Apgar scores are performed and calculated by nursing staff or members of the pediatric team. For this outcome, we are interested in scores less than 7 out of 10 at 5 minutes of life.
Neonatal intensive care unit admission From time of delivery to hospital discharge; up to 6 weeks Admission to the neonatal intensive care unit for greater than 24 hours
Suspected or confirmed neonatal sepsis From time of delivery to hospital discharge; up to 6 weeks As clinical suspected by the neonatology team or with positive cultures
Length of Labor Time from placement of Foley catheter to time of delivery of neonate; up to 5 days hours
Postpartum hemorrhage From time of delivery to time of hospital discharge; up to 6 weeks Delivery estimated blood loss of \> 500 cc for vaginal delivery or \> 1000 cc for cesarean delivery
Delivery time less than 24 hours From time of placement of Foley catheter to time of delivery of neonate; within 24 hours. binary; yes/no
Trial Locations
- Locations (1)
Prentice Women's Hospital
🇺🇸Chicago, Illinois, United States