Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction

Study Overview
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Brief Summary
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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
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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

Official Title
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A Randomized Clinical Trial of Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction

Conditions
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Labor Induction

Intervention / Treatment
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* Procedure: Amniotomy
* Device: Foley Catheter
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Amniotomy<br>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<br>* Artificially rupturing membranes<br>Device: Foley Catheter<br>* 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.<br>Drug: Misoprostol<br>* 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.<br>|
| Active Comparator: Delayed Amniotomy<br>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<br>* Artificially rupturing membranes<br>Device: Foley Catheter<br>* 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.<br>Drug: Misoprostol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time interval from Foley catheter removal to delivery | Hours | Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean delivery | binary; yes/no | 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 | 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 | 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 | From time of delivery to time of hospital discharge; up to 6 weeks | 
| Endometritis | fundal tenderness and fever that required treatment with antibiotics | 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. | 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 | From time of delivery to hospital discharge; up to 6 weeks | 
| Length of Labor | hours | 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 | 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 | From time of delivery to time of hospital discharge; up to 6 weeks | 
| Delivery time less than 24 hours | binary; yes/no | From time of placement of Foley catheter to time of delivery of neonate; within 24 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor Induction, Early Amniotomy, Foley catheter