Impact of Misoprostol on Blood Loss In Myomectomy Operations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr.Ahmed Elnaggar, Ain Shams University
ClinicalTrials.gov Identifier:
NCT02061657
First received: February 11, 2014
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Leiomyoma
Drug: Misoprostol
Drug: Placebo( for misoprostol)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • intraoperative blood loss [ Time Frame: time from peritoneum opening till its closure around (1 Hour) ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2013
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Myomectomy, rectal Misoprostol
25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.
Drug: Misoprostol
25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation
Other Name: Cytotec
Active Comparator: Myomectomy, Placebo
Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
Drug: Placebo( for misoprostol)
Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061657

Locations
Egypt
Ain Shams University, Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
Study Chair: Abd El Mgeed I. Abd El Mgeed, Professor Ain Shams University
Study Director: Mohamed S. Ali, Professor Ain Shams University
Principal Investigator: Mohamed A. Abdel-Hafeez, Lecturer Ain Shams University
Principal Investigator: Mina A. Yacoup, Fellow Ain Shams University
Principal Investigator: Ahmed M. Elnaggar, Lecturer Ain Shams University
  More Information

No publications provided

Responsible Party: Dr.Ahmed Elnaggar, DR, Ain Shams University
ClinicalTrials.gov Identifier: NCT02061657     History of Changes
Other Study ID Numbers: AIN-1111-MM
Study First Received: February 11, 2014
Last Updated: July 14, 2014
Health Authority: Egypt: Ministry of Higher Education

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on July 31, 2014