Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy
Primary Purpose
Blood Loss, Surgical, Uterine Myoma
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
About this trial
This is an interventional other trial for Blood Loss, Surgical
Eligibility Criteria
Inclusion Criteria:
- ASA physical status class I-II
- Intramural or subserosal fibroids - diagnosed on ultrasound
- Candidates for elective abdominal myomectomy
Exclusion Criteria:
- Pre-operative Hemoglobin < 10 g/dl
- Patient who received Danazol or GnRH analogues before surgery
- No other systemic or metabolic disease
Sites / Locations
- PEMH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Misoprostol (Study Group)
No drug
Arm Description
In study group, 400ug misoprostol will be administered through rectal route, 1 hour before surgery.
In control group no dose will be administered
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05108597
First Posted
October 25, 2021
Last Updated
October 25, 2021
Sponsor
Pak Emirates Military Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05108597
Brief Title
Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy
Official Title
Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
March 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pak Emirates Military Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
After getting approval from hospital's ethical committee, patients eligible for the study were recruited in the study according to the selection criteria. Before surgery, after taking informed written consent, patient's detailed history including demographics, parity & BMI was recorded. Uterine size was assessed by bimanual pelvic examination. Patients undergoing myomectomy were randomly divided into 2 groups using lottery method. In experimental group Misoprostol 400ug was administered per rectally prior to surgery. In control group, no drug was administered.
The surgical procedural elements, the surgeon or surgeons performing the procedure and the use of antibiotics as well as anesthetic agents was standardized to remove any bias. Intraoperative blood loss was recorded by a single trained doctor and calculated using visual scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood collected in suction bottle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Uterine Myoma
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
There will be a single trained person who calculated the intra-operative blood loss and was blinded to the randomization of the patients and the use of medication.
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Misoprostol (Study Group)
Arm Type
Experimental
Arm Description
In study group, 400ug misoprostol will be administered through rectal route, 1 hour before surgery.
Arm Title
No drug
Arm Type
No Intervention
Arm Description
In control group no dose will be administered
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Prosotec
Intervention Description
400ug misoprostol will be administered through rectal route, 1 hour before surgery to assess its effect on intra-operative blood loss during myomectomy
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
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.
Time Frame
During the surgical procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA physical status class I-II
Intramural or subserosal fibroids - diagnosed on ultrasound
Candidates for elective abdominal myomectomy
Exclusion Criteria:
Pre-operative Hemoglobin < 10 g/dl
Patient who received Danazol or GnRH analogues before surgery
No other systemic or metabolic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salma Nisar
Organizational Affiliation
Resident OBGYN
Official's Role
Principal Investigator
Facility Information:
Facility Name
PEMH
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Overall results will be shared only.
Learn more about this trial
Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy
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