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:
Rasha Mohammed Mohammed Badawi
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
| Tracking Information | |||||
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| First Received Date ICMJE | June 2, 2012 | ||||
| Last Updated Date | June 4, 2012 | ||||
| Start Date ICMJE | August 2012 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01612390 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor | ||||
| Official Title ICMJE | Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor | ||||
| Brief Summary | Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The study will include (180)randomly allocated |
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| Condition ICMJE | Postpartum Hemorrhage Prevention by Using Oxytocin Verses Misoprostol | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 180 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Egypt | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01612390 | ||||
| Other Study ID Numbers ICMJE | hit 1234 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Rasha Mohammed Mohammed Badawi, Ain Shams University | ||||
| Study Sponsor ICMJE | Rasha Mohammed Mohammed Badawi | ||||
| Collaborators ICMJE | Ain Shams University | ||||
| Investigators ICMJE |
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| Information Provided By | Ain Shams University | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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