Text Size

Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor

This study is not yet open for participant recruitment.
Verified June 2012 by Ain Shams University
Sponsor:
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
Rasha Mohammed Mohammed Badawi, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01612390
First received: June 2, 2012
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  Purpose

Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor


Condition Phase
Postpartum Hemorrhage Prevention by Using Oxytocin Verses Misoprostol
 Phase 0

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • reduce blood loss during third and fourth stages of labor. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    reduce blood loss during third and fourth stages of labor by using misopristol is better than using oxytocin


Secondary Outcome Measures:
  • the duration of the third stage of labor ,need for oxytocics ,blood transfusion and any adverse effects of the drugs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    the duration of the third stage of labor ,needed for oxytocics ,blood transfusion and any adverse effects of the drug will be reduced with mesopristol


Estimated Enrollment: 180
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
group 1
receive 400 Mg sublingual misoprostol.
group 2
receive 600 Mg sublingual misoprostol.
group 3
receive 5IU of intravenous oxytocin.

Detailed Description:

Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor as The data from a pharmacokinetics study suggested that the bioavaiblitiy of misoprostol after sub-lingual administration was higher than those after oral or vaginal administration

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study will include (180)randomly allocated

Criteria

Inclusion Criteria:

  • Women with aheathy singleton pregnancy in spontaneous or induced labor at term .

Exclusion Criteria:

  • Hypersensitivity/Contraindication to prostaglandins Antepartum hemorrhage Multiple pregnancy Cardiac disease Malpresentation Rhesus- negative mother hypersensitive disorders Severe anaemia(hemoglobin<7g/dl)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612390

Contacts
Contact: Rasha mohamed, M.B;B.CH abosalma_82@yahoo.com

Locations
Egypt
AinShamsU
Cairo, Egypt, 44511
Sponsors and Collaborators
Rasha Mohammed Mohammed Badawi
Ain Shams University
Investigators
Principal Investigator: RBadawi mohamed, M.B;B.CH Ain Shams University
  More Information

No publications provided

Responsible Party: Rasha Mohammed Mohammed Badawi, RBadawi, Ain Shams University
ClinicalTrials.gov Identifier: NCT01612390     History of Changes
Other Study ID Numbers: hit 1234
Study First Received: June 2, 2012
Last Updated: June 4, 2012
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Ain Shams University:
postpartum hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Misoprostol
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 19, 2013