NCT04573517

Brief Summary

Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 22, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 4, 2025

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

2.7 years

First QC Date

September 22, 2020

Results QC Date

June 20, 2023

Last Update Submit

February 26, 2025

Conditions

Labor InductionEarly Amniotomy

Keywords

Foley balloon

Outcome Measures

Primary Outcomes (1)

  • Time to Active Phase of Labor

    Total time from initiation of labor induction to reaching 6 cm cervical dilation

    At delivery

Secondary Outcomes (6)

  • Time to Delivery

    At delivery

  • Vaginal Delivery Rate

    At delivery

  • Cesarean Section Rate

    At delivery

  • Maternal Infection Composite

    From admission to discharge, up to 2 weeks

  • Umbilical Cord Prolapse

    At delivery

  • +1 more secondary outcomes

Study Arms (2)

Early amniotomy

EXPERIMENTAL

Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon.

Procedure: AmniotomyDevice: Foley balloon

Delayed amniotomy

ACTIVE COMPARATOR

Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon.

Procedure: AmniotomyDevice: Foley balloon

Interventions

AmniotomyPROCEDURE

Artificial rupture of amniotic membranes

Delayed amniotomyEarly amniotomy
Foley balloonDEVICE

The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.

Also known as: Foley catheter, Foley bulb
Delayed amniotomyEarly amniotomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18
  • Singleton pregnancy
  • Term gestation (37 weeks gestation)
  • Cephalic presentation
  • Undergoing labor induction with transcervical Foley balloon

You may not qualify if:

  • Previous uterine surgery
  • Prelabor rupture of membranes
  • Severe pre-eclampsia, HELLP, or eclampsia
  • HIV, HCV, or HBV
  • Heart disease
  • Fever (≥38 0C) at admission
  • Category II or III fetal heart rate tracing prior to randomization
  • Polyhydramnios
  • Fetal growth restriction \<3%
  • EFW \> 4200 g
  • Fetal demise or major congenital anomaly
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

Related Publications (1)

  • Berry M, Lamiman K, Slan MN, Zhang X, Arena Goncharov DD, Hwang YP, Rogers JA, Pacheco LD, Saade GR, Saad AF. Early vs delayed amniotomy following transcervical Foley balloon in the induction of labor: a randomized clinical trial. Am J Obstet Gynecol. 2024 May;230(5):567.e1-567.e11. doi: 10.1016/j.ajog.2024.01.028. Epub 2024 Feb 15.

    PMID: 38367749DERIVED

MeSH Terms

Interventions

Amniotomy

Intervention Hierarchy (Ancestors)

Labor, InducedDelivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Marissa Berry
Organization
University of Texas Medical Branch
majberry@utmb.edu
402-772-4099

Study Officials

  • Marissa Berry, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2020

First Posted

October 5, 2020

Study Start

October 15, 2020

Primary Completion

June 22, 2023

Study Completion

June 22, 2023

Last Updated

March 4, 2025

Results First Posted

March 4, 2025

Record last verified: 2025-02

Locations

US(1)