An interventional study of Amniotomy and Foley Catheter in Labor Induction, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
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
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Amniotomy · Device: Foley Catheter · Drug: 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.
Procedure: Amniotomy · Device: Foley Catheter · Drug: Misoprostol
Artificially rupturing membranes
Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline. It is removed when either 1. it falls out under gentile traction during labor checks or 2. it is de-inflated at 12 hours after placement. If at the time of de-inflation at 12 hours, the desired affect has not been achieved, the provider may choose to place another foley balloon or use an alternative method of induction (misoprostol). This is an eligibility criteria and only patients who are undergoing induction with a Foley Catheter will be approached for enrollment.
Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg. Use of this medication will be decided by the provider.
Time interval from Foley catheter removal to delivery
Hours
Time frame: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
Cesarean delivery
binary; yes/no
Time frame: At time of delivery
Chorioamnionitis
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
Time frame: From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours
Postpartum Fever
Temperature \>/= 38 degrees celsius on 2 separate occasions greater than 6 hours apart
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
Wound infection
Cellulitis or erythema and induration around the incision and purulent discharge from the incision site with or without fever
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
Endometritis
fundal tenderness and fever that required treatment with antibiotics
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
5 minute Apgar Score less than 7 out of 10
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.
Time frame: 5 minutes following delivery; 5 minutes of neonatal life.
Neonatal intensive care unit admission
Admission to the neonatal intensive care unit for greater than 24 hours
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Length of Labor
hours
Time frame: Time from placement of Foley catheter to time of delivery of neonate; up to 5 days
Suspected or confirmed neonatal sepsis
As clinical suspected by the neonatology team or with positive cultures
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Postpartum hemorrhage
Delivery estimated blood loss of \> 500 cc for vaginal delivery or \> 1000 cc for cesarean delivery
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
Delivery time less than 24 hours
binary; yes/no
Time frame: From time of placement of Foley catheter to time of delivery of neonate; within 24 hours.
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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