NCT02908295

Rectal Misoprostol in Women Undergoing Myomectomy for Intraoperative Blood Loss: A Randomized Placebo-controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: Female
• Age: 25 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women undergoing myomectomy, both open and laparoscopic approach

Detailed description

According to development of reproductive technology to assist infertile women, rate of myomectomy increases. During this operation, surgeons would deal with hypervascular masses with raw surfaces that tend to bleeding. Interventions to diminish bleeding were studied such as using misoprostol, vasopressin, transamenic acid along with mechanical intervention such as tourniquet and uterine artery ligation. But in Rajavithi hospital, such procedures aren't generally used because of fewer cases and also lacks of supporting data. Misoprostol, used in gynecologic patients for a long time with a wide safety margin acts at prostaglandin receptors of myometrium to stimulate contraction that constricts uterine vessels that lead to decreasing amount of bleeding during the operation. This led to the experimental study of rectal misoprostol administered at 15 - 30 minutes prior the operation to decrease blood loss and also blood transfusion rates. Our study also gather data about adverse effect that subject experienced after drug administration.

Conditions

• Misoprostol, Blood Loss, Myomectomy

Interventions

Type	Name	Description
DRUG	Rectal Misoprostol	Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation
DRUG	Placebo	Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-12-31
• Completion: 2018-04-30
• First posted: 2016-09-20
• Last updated: 2020-10-23

Locations

1 site across 1 country: Thailand