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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04496908
Recruitment Status : Not yet recruiting
First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Helen Beatriz Gomez, Christiana Care Health Services

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 200 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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)
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Misoprostol

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496908


Locations
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United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19713
Contact: Helen B Gomez, MD    302-733-6565    helen.gomez@christianacare.org   
Contact: Matthew Hoffman, MD, MPH         
Sponsors and Collaborators
Christiana Care Health Services
Publications:
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Responsible Party: Helen Beatriz Gomez, Resident Physician, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT04496908    
Other Study ID Numbers: DDD# 604698
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics