A Novel Protocol for Labour Induction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
ClinicalTrials.gov Identifier:
NCT01506388
First received: January 4, 2012
Last updated: January 19, 2014
Last verified: January 2014
  Purpose

The use of foley catheter was tested many times and proved to be effective for induction of labour.


Condition Intervention Phase
Failed Induction of Labor
Device: foley catheter
Drug: Misoprostol
Drug: Vaginal IMN
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Foley Catheter Plus Vaginal Isosorbide Mononitrate Versus Vaginal Misoprostol for Induction of Labour:a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • caesarean section rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    caesarean section


Secondary Outcome Measures:
  • time from induction to delivery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    from the insertion of the foley catheter to delivery


Enrollment: 400
Study Start Date: February 2012
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: folye catheter plus vaginal IMN
intracervical foley catheter plus vaginal IMN
Device: foley catheter
foley 14 catheter intracervical plus vaginal IMN 40 mg evry 6 hours
Other Name: foley catheter
Drug: Vaginal IMN
IMN vaginal 40 mg every 4-6 hours
Other Name: Vaginal IMN
Active Comparator: Misoprostol vaginally
intravaginal misoprostol
Drug: Misoprostol
misoprostol 50 Ug , vaginally every 4-6 hours
Other Name: misoprostol vaginally

Detailed Description:

The investigators compare between vaginal misoprostol versus foley catheter plus vaginal isosorbide mononitrate (IMN) for induction of labour

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term or post term pregnancies.
  • Live,singleton fetus.
  • Cephalic presentation.
  • Intact membrane.
  • Bishop score < 6.
  • Not in labour.
  • Medically indicated for labour induction.
  • Primigravida or parity of 3 or less.

Exclusion Criteria:

  • Previous caesarean delivery.
  • Malpresentation.
  • Placenta previa.
  • Sever intrauterine growth restriction.
  • Multiple pregnancy.
  • Polyhydramnios.
  • Oligohydramnios.
  • Bishop score 7 or more.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506388

Locations
Egypt
Cairo University
Cairo, Egypt, 12211
Waleed El-khayat
Cairo, Egypt, 12211
Sponsors and Collaborators
Cairo University
Investigators
Study Director: Waleed El-khayat, M.D. Cairo University
  More Information

No publications provided

Responsible Party: Waleed El-khayat, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT01506388     History of Changes
Other Study ID Numbers: 12012
Study First Received: January 4, 2012
Last Updated: January 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cairo University:
labour induction
Foley catheter
misoprostol
isosorbide mononitrate

Additional relevant MeSH terms:
Isosorbide
Isosorbide-5-mononitrate
Isosorbide Dinitrate
Misoprostol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 17, 2014