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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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double dose misoprostol

2 doses, 3 and 1 hours, prior surgery (group B, 35 cases).

Group Type ACTIVE_COMPARATOR

2 doses 400 microgram misoprostol

Intervention Type DRUG

2 doses 400 microgram misoprostol, 3 and 1 hours

single dose Misoprostol

intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases)

Group Type ACTIVE_COMPARATOR

single dose misoprostol

Intervention Type DRUG

1 dose, 1 hours, prior surgery

Interventions

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2 doses 400 microgram misoprostol

2 doses 400 microgram misoprostol, 3 and 1 hours

Intervention Type DRUG

single dose misoprostol

1 dose, 1 hours, prior surgery

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No