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

Misoprostol, Blood Loss, Myomectomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908295
• Other study ID #: RJMISO
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: September 2016
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patient provisionally diagnosed with leiomyoma of uterus with less than 10 cm diameter

• Patient undergoing myomectomy, both open and laparoscopic approach

• Patient aged 25 - 50 years

• Patient able to give free and informed consent and who agrees to participate bu signing the consent form

• Patient able to speak and understand Thai

• Patient able to complete the questionnaire

Exclusion Criteria:

• Patient who was pathologically diagnosed apart from leiomyoma

• Patient with leiomyoma FIGO type 0

• Patient who has medical conditions that increase bleeding tendency, such as thrombocytopenia, coagulopathy, renal insufficiency, uncontrolled diabetes mellitus, taking antiplatelets or anticoagulants less than 7 days prior the surgery

• Patient who takes prostaglandin analogs and/or antagonists (NSAIDS) less than 7 days prior the surgery.

• Patient who may take higher risks of misoprostol adverse effect such as hypertension, ischemic heart disease, glaucoma, asthma

• Patient who had and allergic reaction to misoprostol or vitamin B6

Related Conditions & MeSH terms

• Hemorrhage
• Misoprostol, Blood Loss, Myomectomy

Intervention

Drug:
• Rectal Misoprostol
Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation
• 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

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean intraoperative blood loss in both groups		Within 3 hours
Secondary	Mean difference of hemoglobin		within 24 hours
Secondary	Incidence of blood transfusion		within 72 hours
Secondary	Incidence of unplanned operation		within 72 hours
Secondary	Incidence of adverse events		within 72 hours