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Impact of Misoprostol on Blood Loss In Myomectomy Operations

Primary Purpose

Leiomyoma

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Misoprostol

Placebo( for misoprostol)

About this trial

This is an interventional prevention trial for Leiomyoma

Eligibility Criteria

35 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Ain Shams University, Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myomectomy, rectal Misoprostol

Myomectomy, Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

intraoperative blood loss

Secondary Outcome Measures

Full Information

NCT ID

NCT02061657

First Posted

February 11, 2014

Last Updated

August 9, 2014

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT02061657

Brief Title

Impact of Misoprostol on Blood Loss In Myomectomy Operations

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leiomyoma

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Myomectomy, rectal Misoprostol

Arm Type

Experimental

Arm Description

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

Arm Title

Myomectomy, Placebo

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Other Intervention Name(s)

Cytotec

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo( for misoprostol)

Intervention Description

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

Primary Outcome Measure Information:

Title

intraoperative blood loss

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: