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A Novel Protocol for Labour Induction

This study is currently recruiting participants.
Verified February 2012 by Cairo University
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
ClinicalTrials.gov Identifier:
NCT01506388
First received: January 4, 2012
Last updated: February 18, 2012
Last verified: February 2012
History of Changes
  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:

U.S. FDA Resources

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


Estimated Enrollment: 400
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 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

Contacts
Contact: Waleed El-khayat, M.D. 01005135542 ext +2 waleed_elkhyat@yahoo.com

Locations
Egypt
Cairo University Recruiting
Cairo, Egypt, 12211
Contact: Waleed El-khayat, M.D.     01005135542 ext +2     waleed_elkhyat@yahoo.com    
Principal Investigator: waleed El-khayat, M.D.            
Waleed El-khayat Recruiting
Cairo, Egypt, 12211
Contact: Waleed El-khayat, M.D.     01005133542 ext 002     Waleed_elkhyat@yahoo.com    
Principal Investigator: Waleed El- khayat, M.D.            
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: February 18, 2012
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 June 18, 2013