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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: |
NCT01700478 |
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Date of registration:
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25/09/2012 |
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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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Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy
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Scientific title:
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A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy |
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Date of first enrolment:
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February 2005 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01700478 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Jamaica
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Contacts
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Name:
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Sharifa K Frederick, dM |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of the West Indies |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients with symptomatic fibroids who desire future fertility and or who wish to
maintain their uterus.
Exclusion Criteria:
- patients who have had previous myomectomy or previous pelvic surgery.
- patients who are severely anemic or who have significant medical conditions such as
cardiac or pulmonary disease.
- patients who refuse to participate or give consent to the procedures. Patients with a
known allergy to any of the study drugs.
Age minimum:
25 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hemorrhage
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Intervention(s)
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Drug: Misoprostol + vasopressin
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Drug: Vasopressin
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Primary Outcome(s)
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Blood loss in millilitres
[Time Frame: At the time of surgery]
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Secondary Outcome(s)
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A change in hemoglobin grams per decilitre
[Time Frame: At baseline and 24hours after surgery]
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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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