Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

• Sponsor: Christiana Care Health Services (Other)
• Overall Status: Completed
• CT.gov ID: NCT04496908
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site Per Month: 12.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Induction of Labor Affected Fetus / Newborn	Procedure: amniotomy; Device: Foley Catheter; Drug: Misoprostol	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Versus Delayed Artificial Rupture of Membranes Following Foley Catheter Ripening in Labor Induction: A Randomized Controlled Trial (AROM Trial)
• Actual Study Start Date: Sep 16, 2020
• Actual Primary Completion Date: May 22, 2021
• Actual Study Completion Date: Oct 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Early Amniotomy 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; 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.; 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.
Active Comparator: Delayed Amniotomy 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; 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.; 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.

Outcome Measures

Primary Outcome Measures

1. time to delivery [Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.]

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

Secondary Outcome Measures

1. Cesarean delivery rate [At time of delivery]

   binary; yes/no

2. Time to vaginal delivery [At time of delivery]

   time to delivery (hours) defined as time from Foley Catheter expulsion to delivery

3. Maternal length of stay [through study completion, an average of 4 days]

   time from admission to discharge

4. Indication for cesarean delivery [At time of delivery]

   discrete

5. Chorioamnionitis [At time of delivery]

   defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness

6. 3rd/4th degree perineal laceration [at time of delivery]

   binary; yes/no

7. Blood transfusion [through study completion, an average of 1 year]

   binary; yes/no

8. Endometritis [From time of delivery to time of hospital discharge; up to 6 weeks]

   binary; yes/no

9. Wound separation-infection [through study completion, an average of 1 year]

   binary, yes/no; defined by the need for additional wound closure or the need for antibiotics

10. Neonatal death [through study completion, an average of 1 year]

    binary, yes/no

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christiana Care Health Systems	Newark	Delaware	United States	19713

Sponsors and Collaborators

• Christiana Care Health Services

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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. Review.

• Responsible Party: Helen Beatriz Gomez, Resident Physician, Christiana Care Health Services
• ClinicalTrials.gov Identifier: NCT04496908
• Other Study ID Numbers: DDD# 604698
• First Posted: Aug 4, 2020
• Last Update Posted: Dec 3, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rupture; Misoprostol

Study Results

No Results Posted as of Dec 3, 2021