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Completed

NCT Number: NCT04496908

Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

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

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Key information

Conditions

Induction of Labor Affected Fetus / Newborn

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Christiana Care Health Systems

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amniotomy

Procedure

Artificially rupturing membranes

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.

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.

Primary outcomes

  1. time to delivery

    Time frame: 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 outcomes

  1. Cesarean delivery rate

    Time frame: At time of delivery

    binary; yes/no

  2. Time to vaginal delivery

    Time frame: At time of delivery

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

  3. Maternal length of stay

    Time frame: through study completion, an average of 4 days

    time from admission to discharge

  4. Indication for cesarean delivery

    Time frame: At time of delivery

    discrete

  5. Chorioamnionitis

    Time frame: 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

    Time frame: at time of delivery

    binary; yes/no

  7. Blood transfusion

    Time frame: through study completion, an average of 1 year

    binary; yes/no

  8. Endometritis

    Time frame: From time of delivery to time of hospital discharge; up to 6 weeks

    binary; yes/no

  9. Wound separation-infection

    Time frame: 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

    Time frame: through study completion, an average of 1 year

    binary, yes/no

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

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

Acronym: AROM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2020
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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