Mechanical Dilation of the Cervix in a Scarred Uterus

NCT03471858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-12-15

No results posted yet for this study

Summary

To determine if mechanical labour induction can offer a safer and effective alternative to prostaglandins to women with previous caesarean section attempting trial of labour after caesarean (TOLAC).

Conditions

  • Pregnancy Related
  • Labor Complication
  • Cesarean Section; Dehiscence

Interventions

DEVICE

Cervical balloon

To assess if a cervical balloon catheter (foleys catheter) for mechanical induction of labour is comparable to prostaglandin usage for induction of labour in women who have had a previous caesarean section.

DRUG

Prostaglandins

Prostin will be used in the control arm.

Sponsors & Collaborators

  • Department of Obstetrics and Gynaecology, National University Hospital

    collaborator UNKNOWN
  • Yong Loo Lin School of Medicine

    collaborator OTHER
  • National University Hospital, Singapore

    collaborator OTHER
  • National University of Singapore

    collaborator OTHER
  • Ministry of Health, Singapore

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-29
Primary Completion
2022-08-27
Completion
2025-08-16

Countries

  • Singapore

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03471858 on ClinicalTrials.gov