Completed

NCT Number: NCT02154932

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

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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Key information

Conditions

Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2 doses 400 microgram misoprostol

Drug

2 doses 400 microgram misoprostol, 3 and 1 hours

single dose misoprostol

Drug

1 dose, 1 hours, prior surgery

Primary outcomes

the operative time

Time frame: from skin to skin in minutes

The time from start till end of surgery
intra and post-operative blood loss

Time frame: during and 6 hours after surgery

collected soaked towels and sucked blood

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jun 3, 2014
Registry last updated: Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.