Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy
Evaluation of the Effect of Rectal Misoprostol on Blood Loss During Abdominal Hysterectomy: A Double Blind Randomized Controlled Trial.
1 other identifier
interventional
220
1 country
1
Brief Summary
Hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur in some cases and sometimes requiring blood transfusion. Recent study proved that misoprostol success in reducing blood loss during total abdominal hysterectomy when used once before the surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 10, 2014
CompletedFirst Posted
Study publicly available on registry
October 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 16, 2014
October 1, 2014
7 months
October 10, 2014
October 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood loss
amount of intra-operative blood loss
8 months
Secondary Outcomes (1)
postoperative hemoglobin level
8 months
Study Arms (2)
Misoprostol
EXPERIMENTAL60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally
Placebo
PLACEBO COMPARATOR60 minutes before the surgery 2 tablets of placebo tablets inserted rectally
Interventions
60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally
60 minutes before the surgery 2 tablet of placebo inserted rectally
Eligibility Criteria
You may qualify if:
- A- Age: adult female \>18 years old. B- Any women undergoing abdominal hysterectomy. C- No contraindications to misoprostol.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University hospiatl
Cairo, 12311, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Waleed El-khyatat, M.D.
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Obstetrics & Gynecology
Study Record Dates
First Submitted
October 10, 2014
First Posted
October 16, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
October 16, 2014
Record last verified: 2014-10