Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor
June 4, 2012 updated by: Rasha Mohammed Mohammed Badawi
Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor
Study Overview
Status
Unknown
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
Study Type
Observational
Enrollment (Anticipated)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rasha mohamed, M.B;B.CH
- Email: abosalma_82@yahoo.com
Study Locations
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Cairo, Egypt, 44511
- AinshamsU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The study will include (180)randomly allocated
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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group 1
receive 400 Mg sublingual misoprostol.
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group 2
receive 600 Mg sublingual misoprostol.
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group 3
receive 5IU of intravenous oxytocin.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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reduce blood loss during third and fourth stages of labor.
Time Frame: 1 year
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reduce blood loss during third and fourth stages of labor by using misopristol is better than using oxytocin
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the duration of the third stage of labor ,need for oxytocics ,blood transfusion and any adverse effects of the drugs
Time Frame: 1 year
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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
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: RBadawi mohamed, M.B;B.CH, ain shams University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Anticipated)
August 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
June 2, 2012
First Submitted That Met QC Criteria
June 4, 2012
First Posted (Estimate)
June 5, 2012
Study Record Updates
Last Update Posted (Estimate)
June 5, 2012
Last Update Submitted That Met QC Criteria
June 4, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hit 1234
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.