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NCT Number: NCT02061657

Impact of Misoprostol on Blood Loss In Myomectomy Operations

The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications

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Key information

Conditions

Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

35 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams University, Maternity Hospital

Cairo, Cairo Governorate, Egypt

About this study

This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital.

A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial.

The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Premenopausal patients aged between 35 to 50 years old.
  • Five or less symptomatic uterine myomas .
  • Maximum diameter of the largest myoma is 6 cm .
  • All myomas are subserous or intramural.
  • Uterine size less than 24 weeks pregnancy

Exclusion criteria

  • History of previous surgery.
  • Allergy to Misoprostol.
  • Hypertension.
  • Cardiac and Pulmonary diseases.
  • Patients who have bleeding disorders.
  • Anemia (Hb < 10g %).
  • Chronic endocrine or metabolic diseases such as Diabetes.
  • Obesity (body mass index > 30 kg/m2).
  • Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Treatment and study plan

Misoprostol

Drug

25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation

Other names: Cytotec

Placebo( for misoprostol)

Drug

Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Primary outcomes

  1. intraoperative blood loss

    Time frame: time from peritoneum opening till its closure around (1 Hour)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2014
Registry last updated
Aug 12, 2014

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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