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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02265562 |
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Date of registration:
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10/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy
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Scientific title:
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Evaluation of the Effect of Rectal Misoprostol on Blood Loss During Abdominal Hysterectomy: A Double Blind Randomized Controlled Trial. |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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220 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02265562 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Waleed EL-khayat, M.D. |
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Address:
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Telephone:
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01005135542 |
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Email:
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waleed_elkhyat@yahoo.com |
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Affiliation:
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Name:
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Waleed El-khyatat, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Name:
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Waleed El-khayat, M.D. |
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Address:
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Telephone:
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01005135542 |
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Email:
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waleed_elkhyat@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
A- Age: adult female >18 years old. B- Any women undergoing abdominal hysterectomy. C- No
contraindications to misoprostol.
Exclusion Criteria:
A -Women with any contraindications to misoprostol including heart disease, mitral
stenosis , severe hypertension ( diastolic pressure over100mm Hg) , hematologic disorders
(as sickle cell anemia ), glaucoma, bronchial asthma, liver disease.
B- Known history of or active medical disorder as DM . C- Pelvic endometriosis and adnexal
mass. D- Those who had undergone previous myomectomy. E- Women who received GnRH analogues
and mifepristone and who are allergic to prostaglandins.
F- Women with mental impairment or incompetent in giving consent. G- Women who don't wish
to participate in the study.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Blood Loss
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Intervention(s)
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Drug: Misoprostol
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Drug: Placebo
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Primary Outcome(s)
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Blood loss
[Time Frame: 8 months]
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Secondary Outcome(s)
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postoperative hemoglobin level
[Time Frame: 8 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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