Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-27 @ 10:15 PM
Study NCT ID:
NCT02908295
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2016-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rectal Misoprostol in Women Undergoing Myomectomy for Intraoperative Blood Loss: A Randomized Placebo-controlled Study
Sponsor:
Department of Medical Services Ministry of Public Health of Thailand
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: