Impact of Misoprostol on Blood Loss In Myomectomy Operations

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02061657

Enrollment

Registered

2014-02-13

Start date

2013-06-30

Completion date

2014-07-31

Last updated

2014-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leiomyoma

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.

Interventions

DRUGMisoprostol

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

DRUGPlacebo( for misoprostol)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame
intraoperative blood loss	time from peritoneum opening till its closure around (1 Hour)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026