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

NCT05108597 | Completed Phase 3

• 1 other identifier: 25102021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss, Surgical; Uterine Myoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Misoprostol (Study Group)

EXPERIMENTAL

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

Drug: Misoprostol

No drug

NO INTERVENTION

In control group no dose will be administered

Interventions

Misoprostol DRUG

400ug misoprostol will be administered through rectal route, 1 hour before surgery to assess its effect on intra-operative blood loss during myomectomy

Also known as: Prosotec

Misoprostol (Study Group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status class I-II
• Intramural or subserosal fibroids - diagnosed on ultrasound
• Candidates for elective abdominal myomectomy

You may not qualify if:

• Pre-operative Hemoglobin \< 10 g/dl
• Patient who received Danazol or GnRH analogues before surgery
• No other systemic or metabolic disease

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

Study Sites (1)

PEMH

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Myofibroma

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Salma Nisar

  Resident OBGYN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident OBGYN

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: March 4, 2019
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2020
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)