Clinical trial NCT04496908: Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)
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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: time to delivery
timeFrame: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
Secondary outcomes:
measure: Cesarean delivery rate
timeFrame: At time of delivery
measure: Time to vaginal delivery
timeFrame: At time of delivery
measure: Maternal length of stay
timeFrame: through study completion, an average of 4 days
measure: Indication for cesarean delivery
timeFrame: At time of delivery
measure: Chorioamnionitis
timeFrame: At time of delivery
measure: 3rd/4th degree perineal laceration
timeFrame: at time of delivery
measure: Blood transfusion
timeFrame: through study completion, an average of 1 year
measure: Endometritis
timeFrame: From time of delivery to time of hospital discharge; up to 6 weeks
measure: Wound separation-infection
timeFrame: through study completion, an average of 1 year
measure: Neonatal death
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Systems
state: Delaware
Study officials:
References:
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;2013(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.
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.
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.
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.
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.
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.