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

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

Study Overview

• Status: Completed
• Conditions: Misoprostol, Blood Loss, Myomectomy
• Intervention / Treatment: Drug: Rectal Misoprostol; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation	Drug: Rectal Misoprostol; Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation; Other Names: Cytotec
Placebo Comparator: B; 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; Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation; Other Names: Besix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean intraoperative blood loss in both groups	Within 3 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: RJMISO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No