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

Rajavithi Hospital

Status and phase

Completed

Phase 4

Conditions

Misoprostol, Blood Loss, Myomectomy

Treatments

Drug: Placebo

Drug: Rectal Misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT02908295

RJMISO

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

Female

Ages

25 to 50 years old

Volunteers

Accepts Healthy Volunteers

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