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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.
Register: TCTR
Last refreshed on: 29 April 2024
Main ID:  TCTR20150924001
Date of registration: 24/09/2015
Prospective Registration: No
Primary sponsor: shahid sadoughi university of medical sciences
Public title: Effect of single rectal dose of Misoprostol prior to abdominal hysterectomy in women with symptomatic leiomyoma: a randomized double blinded clinical trial
Scientific title: Effect of single rectal dose of Misoprostol prior to abdominal hysterectomy in women with symptomatic leiomyoma: a randomized double blinded clinical trial
Date of first enrolment: 22/09/2015
Target sample size:
Recruitment status: Pending (Not yet recruiting)
URL:  https://www.thaiclinicaltrials.org/show/TCTR20150924001
Study type:  Interventional
Study design:  Randomized  
Phase:  Phase 2/Phase 3
Countries of recruitment
iran
Contacts
Name: pouria    yazdian
Address:  yazd-salman street, meqdad avenue, number32 8845432343 yazd Iran
Telephone: +989385101025
Email: pouria_yazdian_a@yahoo.com
Affiliation:  medical student, shahid sadoughi university of medical sciences, yazd, iran
Name: pouria    yazdian
Address:  yazd-salman street, meqdad avenue, number32 8845432343 yazd Iran
Telephone: +989385101025
Email: pouria_yazdian_a@yahoo.com
Affiliation:  medical student, shahid sadoughi university of medical sciences, yazd, iran
Key inclusion & exclusion criteria
Inclusion criteria: patients hospitalized due to uterine myoma in Gynecology ward of Shahid Sadoughi hospital in 2012, candidate for abdominal hysterectomy
Exclusion criteria: chemoterapy

Age minimum: 30 Years
Age maximum: 80 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Fibroids uterine fibroma
Misoprostol
bleeding volume
abdominal hysterectomy
Misoprostol
bleeding volume
abdominal hysterectomy
Intervention(s)
400 micrograms rectal Misoprostol was administered to cases 30 minutes prior to operation. The controls received placebo in return. The patients were hospitalized one day prior to operation. Age, previous operations and BMI were registered. Total bleeding was assessed by blood volume in suction set and surgical Gauzes (15 cc for each gauze and 50 cc for each long gauze). Before, 8 and 30 hours following surgery, Hb levels were registered.
Misoprostol
Experimental Drug
Primary Outcome(s)
Hb levels 8 and 30 hours following surgery micro gram
Secondary Outcome(s)
Age, previous operations and BMI before surgery nil
Secondary ID(s)
nil
Source(s) of Monetary Support
medical university
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed: 30/09/2015
URL:
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