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

Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy
• Intervention / Treatment: Drug: 2 doses 400 microgram misoprostol; Drug: single dose misoprostol

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: double dose misoprostol; 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases).	Drug: 2 doses 400 microgram misoprostol; 2 doses 400 microgram misoprostol, 3 and 1 hours
Active Comparator: single dose Misoprostol; intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases)	Drug: single dose misoprostol; 1 dose, 1 hours, prior surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 31, 2014
• First Submitted That Met QC Criteria: May 31, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Estimate): June 3, 2014
• Last Update Submitted That Met QC Criteria: May 31, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Myomectomy, Misoprostol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: AB123