Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

Induction of Labor Affected Fetus / Newborn Clinical Trial

— AROM  

Official title:

Early Versus Delayed Artificial Rupture of Membranes Following Foley Catheter Ripening in Labor Induction: A Randomized Controlled Trial (AROM Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496908
• Other study ID #: DDD# 604698
• Status: Completed
• Phase: Early Phase 1
• Start date: September 16, 2020
• Est. completion date: October 18, 2021

Study information

• Verified date: November 2021
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 18, 2021
• Est. primary completion date: May 22, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn
• Rupture

Intervention

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.

Locations

Country	Name	City	State
United States	Christiana Care Health Systems	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cesarean delivery rate	binary; yes/no	At time of delivery
Secondary	Time to vaginal delivery	time to delivery (hours) defined as time from Foley Catheter expulsion to delivery	At time of delivery
Secondary	Maternal length of stay	time from admission to discharge	through study completion, an average of 4 days
Secondary	Indication for cesarean delivery	discrete	At time of delivery
Secondary	Chorioamnionitis	defined by the presence of maternal fever =100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness	At time of delivery
Secondary	3rd/4th degree perineal laceration	binary; yes/no	at time of delivery
Secondary	Blood transfusion	binary; yes/no	through study completion, an average of 1 year
Secondary	Endometritis	binary; yes/no	From time of delivery to time of hospital discharge; up to 6 weeks
Secondary	Wound separation-infection	binary, yes/no; defined by the need for additional wound closure or the need for antibiotics	through study completion, an average of 1 year
Secondary	Neonatal death	binary, yes/no	through study completion, an average of 1 year