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Completed

NCT Number: NCT05108597

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Prosotec

Primary outcomes

  1. Intraoperative blood loss

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pak Emirates Military Hospital

Other

Registry information

Official study title

Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy A Randomized Control Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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