Clinical trial NCT02908295: Rectal Misoprostol in Women Undergoing Myomectomy for Intraoperative Blood Loss: A Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Misoprostol, Blood Loss, Myomectomy
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2016-09-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean intraoperative blood loss in both groups
timeFrame: Within 3 hours
Secondary outcomes:
measure: Mean difference of hemoglobin
timeFrame: within 24 hours
measure: Incidence of blood transfusion
timeFrame: within 72 hours
measure: Incidence of unplanned operation
timeFrame: within 72 hours
measure: Incidence of adverse events
timeFrame: within 72 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi hospital
Study officials:
References: