NCT04216628

Brief Summary

The objective of this study is to investigate the course of labor in early versus late amniotomy following balloon cervical ripening in women undergoing term induction of labor stratified by parity.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 10, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

2.9 years

First QC Date

December 11, 2019

Last Update Submit

August 30, 2023

Conditions

Induction of Labor Affected Fetus / Newborn

Keywords

AmniotomyCervical ripeningOxytocinExrea amniotic baloon

Outcome Measures

Primary Outcomes (2)

  • Time to delivery

    The time from induction defined as the primary intervention following balloon expulsion to delivery.

    Up to 96 Hours

  • Delivery within 24 hours

    The proportion of women that delivered within 24 hours of induction

    Up to 96 Hours

Secondary Outcomes (9)

  • Cesarean delivery

    Up to 96 Hours

  • Operative delivery

    Up to 96 Hours

  • Intrapartum fever

    Up to 96 Hours

  • Postpartum fever during the postpartum hospital stay

    Up to 7 days

  • Post partum hemorrhage

    Up to 7 days

  • +4 more secondary outcomes

Study Arms (2)

Early amniotomy group

OTHER

Amniotomy will be performed as the exclusive primary intervention. Oxytocin infusion will begin as per local standard dose protocol no earlier than 2 hours following amniotomy.

Other: Amniotomy

Late amniotomy group

OTHER

Oxytocin infusion will begin as per local standard dose protocol. Amniotomy will be performed no earlier than 2 hours following the commence of oxytocin infusion

Other: Amniotomy

Interventions

AmniotomyOTHER

Artificial rupturing of membranes and IV infusion of Oxytocin

Also known as: Oxytocin
Early amniotomy groupLate amniotomy group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsInduction of labor : Women with a singleton viable gestation undergoing indicated labor induction at term (37-42 weeks of gestation).
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age 37-42 weeks
  • Singleton pregnancy
  • Vertex presentation
  • Medical indication for induction of labor
  • Need for cervical ripening (Bishop score \<=6)
  • Consent to participate in the study
  • Women age at or \>18 years

You may not qualify if:

  • Multiple pregnancies
  • Preterm pregnancy
  • Previous cesarean section
  • Uterine malformation
  • Withdrawal of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta Ashdod

Ashdod, Israel

Location

Related Publications (9)

  • Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8.

    PMID: 24941926BACKGROUND

  • Saccone G, Berghella V. Induction of labor at full term in uncomplicated singleton gestations: a systematic review and metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2015 Nov;213(5):629-36. doi: 10.1016/j.ajog.2015.04.004. Epub 2015 Apr 13.

    PMID: 25882916BACKGROUND

  • ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.

    PMID: 19623003BACKGROUND

  • Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.

    PMID: 22419277BACKGROUND

  • 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.

    PMID: 22959833BACKGROUND

  • Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.

    PMID: 27500341BACKGROUND

  • Schoen CN, Grant G, Berghella V, Hoffman MK, Sciscione A. Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jun;129(6):1046-1053. doi: 10.1097/AOG.0000000000002032.

    PMID: 28486381BACKGROUND

  • Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.

    PMID: 18515515BACKGROUND

  • 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.

    PMID: 11888099BACKGROUND

MeSH Terms

Interventions

AmniotomyOxytocin

Intervention Hierarchy (Ancestors)

Labor, InducedDelivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, OperativePituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Yael Ganor Paz, MD

    Assuta Ashdod medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1. For the early amniotomy group amniotomy will be performed as the exclusive primary intervention. Oxytocin infusion will begin as per local standard dose protocol no earlier than 2 hours following amniotomy. 2. For the late amniotomy group oxytocin infusion will begin as per local standard dose protocol. Amniotomy will be performed no earlier than 2 hours following the commence of oxytocin infusion
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician, OBGYN department

Study Record Dates

First Submitted

December 11, 2019

First Posted

January 3, 2020

Study Start

February 10, 2020

Primary Completion

January 11, 2023

Study Completion

January 11, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)