Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy

Phase 4

Completed

• Conditions: Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy
• Interventions: Drug: 2 doses 400 microgram misoprostol; Drug: single dose misoprostol

• Registration Number: NCT02154932
• Lead Sponsor: Mansoura University

Brief Summary

Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 "Misoprostol, 400 microgram" during myomectomy for multiple uterine fibroids. This was a prospective randomized controlled trial comprised of 69 patients with multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and post-operative blood loss, hemoglobin concentration, blood pressure and body's temperature were estimated and compared in both groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-05
• Study First Submitted: 2014-05-31
• Study First Submitted QC: 2014-05-31
• Last Update Submitted: 2014-05-31
• Study First Posted: 2014-06-03
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

• All patients had symptomatic multiple uterine fibroids (abnormal vaginal bleeding, lower abdominal dull aching pain and pelvic heaviness, subfertility or recurrent abortion)

Exclusion Criteria

• hypertension, cardiac and pulmonary disease, chronic endocrine or metabolic diseases such as diabetes, obesity (body mass index >30 kg/m2), all cases of single myoma and those known to be allergic to prostaglandin preparations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
double dose misoprostol	2 doses 400 microgram misoprostol	2 doses, 3 and 1 hours, prior surgery (group B, 35 cases).
single dose Misoprostol	single dose misoprostol	intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases)

Primary Outcome Measures

Name	Time	Method
the operative time	from skin to skin in minutes	The time from start till end of surgery
intra and post-operative blood loss	during and 6 hours after surgery	collected soaked towels and sucked blood