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

NCT02908295 | Completed Phase 4

• 1 other identifier: RJMISO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Misoprostol, Blood Loss, Myomectomy

Outcome Measures

Primary Outcomes (1)

• Mean intraoperative blood loss in both groups

  Within 3 hours

Secondary Outcomes (4)

• Mean difference of hemoglobin

  within 24 hours

• Incidence of blood transfusion

  within 72 hours

• Incidence of unplanned operation

  within 72 hours

• Incidence of adverse events

  within 72 hours

Study Arms (2)

A

EXPERIMENTAL

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

Drug: Rectal Misoprostol

B

PLACEBO COMPARATOR

Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation

Drug: Placebo

Interventions

Rectal Misoprostol DRUG

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

Also known as: Cytotec

A

Placebo DRUG

Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation

Also known as: Besix

B

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: April 30, 2018
• Last Updated: October 23, 2020

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)