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Completed

NCT Number: NCT02709564

Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy

The aim of the study is to compare the effectiveness of sublingual administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus placebo before myomectomy to decrease blood loss during and after the operation.

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Key information

Conditions

Blood Loss in Myomectomy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
  • Age ≥ 18 years and ≤ 50 years
  • Pre-operative hemoglobin >8 g/dl
  • Ability to understand and the willingness to sign a written informed consent.
  • Admissible medical/surgical history
  • Five or less symptomatic uterine myomas
  • All myomas are subserous or intramural.
  • Uterine size less than 24 weeks pregnancy

Exclusion criteria

  • Patients who have had a prior abdominal myomectomy
  • Post-menopausal women
  • Patients with known bleeding/clotting disorders
  • Patients with a history of gynecologic malignancy
  • Hypertension.
  • Cardiac and Pulmonary diseases.
  • Obesity (body mass index > 30 kg/m2).
  • History of allergic reactions attributed to misoprostol
  • Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Treatment and study plan

Misoprostol 400 sublingual

Drug

patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery

placebo 400 sublingual

Drug

patients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery

Primary outcomes

  1. Mean amount of intraoperative blood loss

    Time frame: intraoperative

Secondary outcomes

  1. Change of hemoglobin after surgery

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Single Dose Versus Two Doses of Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial

Acronym: SL-MISO

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 16, 2016
Registry last updated
May 7, 2020

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.