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Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy

Sponsor
Pak Emirates Military Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05108597
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
16.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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.
Primary Purpose:
Other
Official Title:
Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy A Randomized Control Trial
Actual Study Start Date :
Mar 4, 2019
Actual Primary Completion Date :
Mar 4, 2020
Actual Study Completion Date :
Mar 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Misoprostol (Study Group)

In study group, 400ug misoprostol will be administered through rectal route, 1 hour before surgery.

Drug: Misoprostol
400ug misoprostol will be administered through rectal route, 1 hour before surgery to assess its effect on intra-operative blood loss during myomectomy
Other Names:
  • Prosotec

    		•
    No Intervention: No drug

    In control group no dose will be administered

    Outcome Measures

    Primary Outcome Measures

    1. Intraoperative blood loss [During the surgical procedure]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PEMH Rawalpindi Punjab Pakistan 46000

    Sponsors and Collaborators

    • Pak Emirates Military Hospital

    Investigators

    • Principal Investigator: Salma Nisar, Resident OBGYN

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Salma Nisar, Resident OBGYN, Pak Emirates Military Hospital
    ClinicalTrials.gov Identifier:
    NCT05108597
    Other Study ID Numbers:
    • 25102021
    First Posted:
    Nov 5, 2021
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Hemorrhage
    Blood Loss, Surgical
    Misoprostol

    Study Results

    No Results Posted as of Nov 5, 2021