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Early Versus Delayed Artificial Rupture of Membranes (AROM Trial) (AROM)

Primary Purpose

Induction of Labor Affected Fetus / Newborn

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
amniotomy
Foley Catheter
Misoprostol
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Induction of Labor Affected Fetus / Newborn

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥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

Exclusion Criteria:

  • 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
  • Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies.

Sites / Locations

  • Christiana Care Health Systems

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early Amniotomy

Delayed Amniotomy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cesarean delivery rate
binary; yes/no
Time to vaginal delivery
time to delivery (hours) defined as time from Foley Catheter expulsion to delivery
Maternal length of stay
time from admission to discharge
Indication for cesarean delivery
discrete
Chorioamnionitis
defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness
3rd/4th degree perineal laceration
binary; yes/no
Blood transfusion
binary; yes/no
Endometritis
binary; yes/no
Wound separation-infection
binary, yes/no; defined by the need for additional wound closure or the need for antibiotics
Neonatal death
binary, yes/no

Full Information

First Posted
July 27, 2020
Last Updated
November 22, 2021
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT04496908
Brief Title
Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)
Acronym
AROM
Official Title
Early Versus Delayed Artificial Rupture of Membranes Following Foley Catheter Ripening in Labor Induction: A Randomized Controlled Trial (AROM Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
May 22, 2021 (Actual)
Study Completion Date
October 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Christiana Care Health Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induction of Labor Affected Fetus / Newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Amniotomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Delayed Amniotomy
Arm Type
Active Comparator
Arm Description
Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given.
Intervention Type
Procedure
Intervention Name(s)
amniotomy
Intervention Description
Artificially rupturing membranes
Intervention Type
Device
Intervention Name(s)
Foley Catheter
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
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.
Primary Outcome Measure Information:
Title
time to delivery
Description
time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery.
Time Frame
Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
Secondary Outcome Measure Information:
Title
Cesarean delivery rate
Description
binary; yes/no
Time Frame
At time of delivery
Title
Time to vaginal delivery
Description
time to delivery (hours) defined as time from Foley Catheter expulsion to delivery
Time Frame
At time of delivery
Title
Maternal length of stay
Description
time from admission to discharge
Time Frame
through study completion, an average of 4 days
Title
Indication for cesarean delivery
Description
discrete
Time Frame
At time of delivery
Title
Chorioamnionitis
Description
defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness
Time Frame
At time of delivery
Title
3rd/4th degree perineal laceration
Description
binary; yes/no
Time Frame
at time of delivery
Title
Blood transfusion
Description
binary; yes/no
Time Frame
through study completion, an average of 1 year
Title
Endometritis
Description
binary; yes/no
Time Frame
From time of delivery to time of hospital discharge; up to 6 weeks
Title
Wound separation-infection
Description
binary, yes/no; defined by the need for additional wound closure or the need for antibiotics
Time Frame
through study completion, an average of 1 year
Title
Neonatal death
Description
binary, yes/no
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥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 Exclusion Criteria: 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 Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies.
Facility Information:
Facility Name
Christiana Care Health Systems
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23926074
Citation
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;(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.
Results Reference
background
PubMed Identifier
22959833
Citation
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.
Results Reference
background
PubMed Identifier
11888099
Citation
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.
Results Reference
background
PubMed Identifier
27824758
Citation
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.
Results Reference
background
PubMed Identifier
20502296
Citation
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.
Results Reference
background
PubMed Identifier
35135684
Citation
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.
Results Reference
derived

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Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

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