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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Rasha Mohammed Mohammed Badawi, Ain Shams University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612390
First Posted: June 5, 2012
Last Update Posted: June 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
Rasha Mohammed Mohammed Badawi, Ain Shams University
  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 Early Phase 1

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:


Further study details as provided by Rasha Mohammed Mohammed Badawi, Ain Shams University:

Primary Outcome Measures:
  • reduce blood loss during third and fourth stages of labor. [ Time Frame: 1 year ]
    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 ]
    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

Information from the National Library of Medicine

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

Responsible Party: Rasha Mohammed Mohammed Badawi, RBadawi, Ain Shams University
ClinicalTrials.gov Identifier: NCT01612390     History of Changes
Other Study ID Numbers: hit 1234
First Submitted: June 2, 2012
First Posted: June 5, 2012
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Rasha Mohammed Mohammed Badawi, 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
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents


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