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

Phase 3

Completed

• Conditions: Blood Loss, Surgical; Uterine Myoma
• Interventions: Drug: Misoprostol

• Registration Number: NCT05108597
• Lead Sponsor: Pak Emirates Military Hospital

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.

Study Timeline

• Study Start: 2019-03-04
• Primary Completion: 2020-03-04
• Study Completion: 2020-03-04
• Status Verified: 2021-10
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Last Update Submitted: 2021-10-25
• Study First Posted: 2021-11-05
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol (Study Group)	Misoprostol	In study group, 400ug misoprostol will be administered through rectal route, 1 hour before surgery.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

PEMH; 🇵🇰 Rawalpindi, Punjab, Pakistan