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Balloon Catheter Versus Propess for Labour Induction

NCT03199820 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-04-09

No results posted yet for this study

Summary

This study will randomise low-risk women to compare the effectiveness of trans-cervical balloon catheter for pre-induction cervical ripening for out-patient induction of labour with current practice (Propess). Women will be randomised to two treatment groups. The investigators wish to explore if such a trial is feasible, acceptable to women and what data collection is required for a future trial. Since no data exist, the investigators propose a study with approximately 60 women in each arm across two recruiting sites.

Conditions

  • Childbirth Problems
  • Labor Complication

Interventions

DEVICE

Cook cervical balloon

trans-cervical balloon catheter for out-patient labour induction

DRUG

Prostin E2 Vaginal Suppository

Propess Vaginal suppository for out-patient Labour induction

Sponsors & Collaborators

  • City, University of London

    collaborator OTHER

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Amarnath Bhide, MD · St. George's University Hospitals Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2019-01-31
Completion
2019-05-31

Countries

  • United Kingdom

Study Locations

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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 NCT03199820 on ClinicalTrials.gov