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

Last updated: October 25, 2021
Sponsor: Pak Emirates Military Hospital
Overall Status: Completed

Phase

3

Condition

Hemorrhage

Uterine Fibroids

Sarcoma (Pediatric)

Treatment

N/A

Clinical Study ID

NCT05108597
25102021
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ASA physical status class I-II
  2. Intramural or subserosal fibroids - diagnosed on ultrasound
  3. Candidates for elective abdominal myomectomy

Exclusion

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

Study Design

Total Participants: 200
Study Start date:
March 04, 2019
Estimated Completion Date:
March 04, 2020

Study 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.

Connect with a study center

  • PEMH

    Rawalpindi, Punjab 46000
    Pakistan

    Site Not Available

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