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A Novel Protocol for Labour Induction

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ClinicalTrials.gov Identifier: NCT01506388
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University

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

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Foley Catheter Plus Vaginal Isosorbide Mononitrate Versus Vaginal Misoprostol for Induction of Labour:a Randomised Controlled Trial
Study Start Date : February 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arm Intervention/treatment
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
Drug: Vaginal IMN
IMN vaginal 40 mg every 4-6 hours
Active Comparator: Misoprostol vaginally
intravaginal misoprostol
Drug: Misoprostol
misoprostol 50 Ug , vaginally every 4-6 hours
Other Name: misoprostol vaginally



Primary Outcome Measures :
  1. caesarean section rate [ Time Frame: 1 year ]
    caesarean section


Secondary Outcome Measures :
  1. time from induction to delivery [ Time Frame: 1 year ]
    from the insertion of the foley catheter to delivery



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Waleed El-khayat, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT01506388     History of Changes
Other Study ID Numbers: 12012
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Waleed El-khayat, Cairo University:
labour induction
Foley catheter
misoprostol
isosorbide mononitrate

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