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

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.

Study Overview

• Status: Completed
• Conditions: Labor Induction
• Intervention / Treatment: Procedure: Amniotomy; Device: Foley Catheter; Drug: Misoprostol

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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Prentice Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early 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.	Procedure: Amniotomy; Artificially rupturing membranes; Device: Foley Catheter; 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.; Drug: Misoprostol; 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.
Active Comparator: Delayed 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.	Procedure: Amniotomy; Artificially rupturing membranes; Device: Foley Catheter; 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.; Drug: Misoprostol; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Emily Miller, MD, Northwestern University

Publications and helpful links

General Publications

• Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
• Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
• Levy R, Ferber A, Ben-Arie A, Paz B, Hazan Y, Blickstein I, Hagay ZJ. A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter. BJOG. 2002 Feb;109(2):168-72. doi: 10.1111/j.1471-0528.2002.01137.x.
• Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
• Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8.
• Maslow AS, Sweeny AL. Elective induction of labor as a risk factor for cesarean delivery among low-risk women at term. Obstet Gynecol. 2000 Jun;95(6 Pt 1):917-22. doi: 10.1016/s0029-7844(00)00794-8.
• Garcia-Simon R, Montanes A, Clemente J, Del Pino MD, Romero MA, Fabre E, Oros D. Economic implications of labor induction. Int J Gynaecol Obstet. 2016 Apr;133(1):112-5. doi: 10.1016/j.ijgo.2015.08.022. Epub 2015 Dec 18.
• Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
• Smyth RM, Markham C, Dowswell T. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD006167. doi: 10.1002/14651858.CD006167.pub4.
• Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol. 2006 Sep;49(3):642-57. doi: 10.1097/00003081-200609000-00022.
• Mizrachi Y, Levy M, Bar J, Kovo M. Induction of labor in nulliparous women with unfavorable cervix: a comparison of Foley catheter and vaginal prostaglandin E2. Arch Gynecol Obstet. 2016 Oct;294(4):725-30. doi: 10.1007/s00404-016-4026-9. Epub 2016 Feb 2.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Foley catheter; Labor Induction; Early Amniotomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: STU00204292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No