NCT03588585

Brief Summary

To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 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

Study Start

First participant enrolled

April 16, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

7.8 years

First QC Date

June 22, 2018

Last Update Submit

February 17, 2026

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

  • Time to Delivery

    Reduction in time to delivery

    Will measure length of time from beginning of induction with the foley balloon until delivery

Study Arms (2)

Tension

ACTIVE COMPARATOR

foley balloon will be placed on tension and taped to thigh at 10 cm. Misoprostil will be placed in posterior vaginal vault.

Procedure: Tension

No tension

ACTIVE COMPARATOR

The foley balloon will be loosely taped without tension to the patient's thigh. Misoprostil will be placed in the posterior vaginal vault.

Procedure: NO TENSION

Interventions

TensionPROCEDURE

Tension applied to catheter and taped firmly to leg.

Also known as: misoprostil 25 mcg
Tension
NO TENSIONPROCEDURE

Foley balloon will be taped loosely to the leg and not placed on tension. All other care will remain the same

Also known as: misoprostil 25 mcg
No tension

Eligibility Criteria

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

You may qualify if:

  • Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children.
  • Cephalic presentation
  • Intact fetal membranes
  • Bishop score less than or equal to 6
  • Age greater than or equal to 18 years

You may not qualify if:

  • Multiparas
  • Multiple gestation
  • Previous uterine/cervical surgery
  • Ruptured fetal membranes
  • Fetal malpresentation
  • Any contraindication to vaginal delivery at time of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 17, 2018

Study Start

April 16, 2018

Primary Completion

February 9, 2026

Study Completion

February 9, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

US(1)