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Trial record 94 of 229 for:    pyridoxine

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

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ClinicalTrials.gov Identifier: NCT02908295
Recruitment Status : Unknown
Verified September 2016 by Kanya Boonthongtho, Rajavithi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 20, 2016
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Kanya Boonthongtho, Rajavithi Hospital

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

Condition or disease Intervention/treatment Phase
Misoprostol, Blood Loss, Myomectomy Drug: Rectal Misoprostol Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

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 Name: 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 Name: Besix




Primary Outcome Measures :
  1. Mean intraoperative blood loss in both groups [ Time Frame: Within 3 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Kanya Boonthongtho, Pruttaporn Maneerat, MD Sirikarn Thongmai, MD, Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT02908295     History of Changes
Other Study ID Numbers: RJMISO
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vitamin B 6
Hemorrhage
Pathologic Processes
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances