Blood Loss, Surgical Clinical Trial
Official title:
Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy A Randomized Control Trial
Verified date | October 2021 |
Source | Pak Emirates Military Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A total of 200 women for elective abdominal myomectomy were randomly allocated into two groups. 100 women in experimental group were administered 400ug Misoprostol (2 tablets of Prosotec®) through the rectal route prior to surgery and 100 were in control group, in which no drug was administered.
Status | Completed |
Enrollment | 200 |
Est. completion date | March 4, 2020 |
Est. primary completion date | March 4, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. ASA physical status class I-II 2. Intramural or subserosal fibroids - diagnosed on ultrasound 3. Candidates for elective abdominal myomectomy Exclusion Criteria: 1. Pre-operative Hemoglobin < 10 g/dl 2. Patient who received Danazol or GnRH analogues before surgery 3. No other systemic or metabolic disease |
Country | Name | City | State |
---|---|---|---|
Pakistan | PEMH | Rawalpindi | Punjab |
Lead Sponsor | Collaborator |
---|---|
Pak Emirates Military Hospital |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative blood loss | Intraoperative blood loss will be recorded by a trained doctor and calculated using visual scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood collected in suction bottle. | During the surgical procedure |
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