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

NCT03039036 | Completed DMC

• 1 other identifier: STU00204292
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Induction

Keywords

Labor Induction; Early Amniotomy; Foley catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Cesarean delivery

  At time of delivery

• Chorioamnionitis

  From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours

• Postpartum Fever

  From time of delivery to time of hospital discharge; up to 6 weeks

• Wound infection

  From time of delivery to time of hospital discharge; up to 6 weeks

• Endometritis

  From time of delivery to time of hospital discharge; up to 6 weeks

Study Arms (2)

Early Amniotomy

EXPERIMENTAL

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

Delayed Amniotomy

ACTIVE COMPARATOR

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

Interventions

Amniotomy PROCEDURE

Artificially rupturing membranes

Delayed Amniotomy; Early Amniotomy

Foley Catheter DEVICE

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.

Delayed Amniotomy; Early Amniotomy

Misoprostol DRUG

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.

Delayed Amniotomy; Early Amniotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

• Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8.

  PMID: 24941926 BACKGROUND

• 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.

  PMID: 10831992 BACKGROUND

• 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.

  PMID: 26868065 BACKGROUND

• 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.

  PMID: 23303106 BACKGROUND

• Smyth RM, Markham C, Dowswell T. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2013 Jun 18;2013(6):CD006167. doi: 10.1002/14651858.CD006167.pub4.

  PMID: 23780653 BACKGROUND

• 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.

  PMID: 16885669 BACKGROUND

• 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.

  PMID: 22419277 BACKGROUND

• 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.

  PMID: 26837386 BACKGROUND

• 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.

  PMID: 11888099 BACKGROUND

• 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.

  PMID: 27500341 BACKGROUND

• 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.

  PMID: 27824758 BACKGROUND

MeSH Terms

Interventions

Amniotomy; Misoprostol

Intervention Hierarchy (Ancestors)

Labor, Induced; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Emily Miller, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: February 1, 2017
• Study Start: September 12, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)