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Completed

NCT Number: NCT02908295

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

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Key information

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Rajavithi hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rectal Misoprostol

Drug

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

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

Other names: Besix

Primary outcomes

  1. Mean intraoperative blood loss in both groups

    Time frame: Within 3 hours

Secondary outcomes

  1. Mean difference of hemoglobin

    Time frame: within 24 hours

  2. Incidence of blood transfusion

    Time frame: within 72 hours

  3. Incidence of unplanned operation

    Time frame: within 72 hours

  4. Incidence of adverse events

    Time frame: within 72 hours

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 20, 2016
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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