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Induction of Labor Affected Fetus / NewbornEarly Phase 1AROMNCT04496908

Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

A Early Phase 1 study testing amniotomy, Foley Catheter and Misoprostol in people with Induction of Labor Affected Fetus / Newborn, run by Christiana Care Health Services at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
What is being tested?
amniotomy, Foley Catheter and Misoprostol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
16 Sep 2020to 18 Oct 2021
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • ≥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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Christiana Care Health Systems

    Newark, Delaware, 19713

Other trials in United States

About this study

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

Read more

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

Being tested
amniotomy, Foley Catheter, Misoprostol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • amniotomyProcedure or surgery

    Artificially rupturing membranes

  • Foley CatheterDevice

    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.

  • MisoprostolDrug

    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.

Study groups in NCT04496908
Study groupRoleWhat they receive
Early AmniotomyActive comparatorWomen 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.
Receives: Procedure: amniotomy; Device: Foley Catheter; Drug: Misoprostol
Delayed AmniotomyActive comparatorWomen in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given.
Receives: Procedure: amniotomy; Device: Foley Catheter; Drug: Misoprostol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to delivery

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

    Measured: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.

Secondary outcomes (10)

  1. Cesarean delivery rate

    binary; yes/no

    Measured: At time of delivery

  2. Time to vaginal delivery

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

    Measured: At time of delivery

  3. Maternal length of stay

    time from admission to discharge

    Measured: through study completion, an average of 4 days

  4. Indication for cesarean delivery

    discrete

    Measured: At time of delivery

  5. Chorioamnionitis

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

    Measured: At time of delivery

  6. 3rd/4th degree perineal laceration

    binary; yes/no

    Measured: at time of delivery

  7. Blood transfusion

    binary; yes/no

    Measured: through study completion, an average of 1 year

  8. Endometritis

    binary; yes/no

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

  9. Wound separation-infection

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

    Measured: through study completion, an average of 1 year

  10. Neonatal death

    binary, yes/no

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start16 Sep 2020
  3. Primary completion22 May 2021
  4. Study completion18 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04496908
Sponsor's protocol ID
DDD# 604698
Acronym
AROM
Status last verified
Nov 2021
First submitted
27 Jul 2020
Last updated
3 Dec 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23926074

  • 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.

    PubMed 22959833

  • 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.

    PubMed 11888099

  • 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.

    PubMed 27824758

  • 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.

    PubMed 20502296

  • 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.

    PubMed 35135684

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing amniotomy, Foley Catheter and Misoprostol in people with Induction of Labor Affected Fetus / Newborn, run by Christiana Care Health Services at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to delivery (time frame: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04496908, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.

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