Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

NCT04496908 | Completed Early Phase 1 FDA Drug

• 1 other identifier: DDD# 604698
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy. This project will include 157 women presenting at Christiana Care Health System. 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 combined with either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy Women will be randomized with equal probability to the intervention group using block randomization stratified by party. Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

• time to delivery

  time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery.

  Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.

Secondary Outcomes (10)

• Cesarean delivery rate

  At time of delivery

• Time to vaginal delivery

  At time of delivery

• Maternal length of stay

  through study completion, an average of 4 days

• Indication for cesarean delivery

  At time of delivery

• Chorioamnionitis

  At time of delivery

Study Arms (2)

Early Amniotomy

ACTIVE COMPARATOR

Women in the Early AROM group will under amniotomy one hour from Foley Catheter expulsion. Labor augmentation will continue per study protocol. Refer to Appendix A for protocol regimen.

Procedure: amniotomy; Device: Foley Catheter; Drug: Misoprostol

Delayed Amniotomy

ACTIVE COMPARATOR

Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given.

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.

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.

Delayed Amniotomy; Early Amniotomy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥18 years of age
• full term (≥37 weeks) gestations determined by routine obstetrical guidelines
• singleton gestation in cephalic presentation
• Both nulliparous and multiparous women
• Intact membranes
• Bishop score of ≤6 and cervical dilation ≤2cm

You may not qualify if:

• Any contraindication to a vaginal delivery or to misoprostol
• fetal demise
• Multifetal gestation
• major fetal anomaly
• prior uterine surgery, previous cesarean section
• women with HIV, hepatitis C, hepatitis B, and women with medical conditions requiring an assisted second stage

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health Systems

Newark, Delaware, 19713, United States

Location

Related Publications (6)

• Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 2013 Aug 7;2013(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.

  PMID: 23926074 BACKGROUND

• Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24.

  PMID: 22959833 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

• 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

• Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.

  PMID: 20502296 BACKGROUND

• Gomez Slagle HB, Fonge YN, Caplan R, Pfeuti CK, Sciscione AC, Hoffman MK. Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial. Am J Obstet Gynecol. 2022 May;226(5):724.e1-724.e9. doi: 10.1016/j.ajog.2021.11.1368. Epub 2022 Feb 6.

  PMID: 35135684 DERIVED

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 Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 4, 2020
• Study Start: September 16, 2020
• Primary Completion: May 22, 2021
• Study Completion: October 18, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)