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

Primary Purpose

Misoprostol, Blood Loss, Myomectomy

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Rectal Misoprostol

Placebo

About this trial

This is an interventional treatment trial for Misoprostol, Blood Loss, Myomectomy

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

Rajavithi hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation

Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation

Outcomes

Primary Outcome Measures

Mean intraoperative blood loss in both groups

Secondary Outcome Measures

Mean difference of hemoglobin

Incidence of blood transfusion

Incidence of unplanned operation

Incidence of adverse events

Full Information

NCT ID

NCT02908295

First Posted

September 16, 2016

Last Updated

October 21, 2020

Sponsor

Rajavithi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02908295

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

September 1, 2016 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rajavithi Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Misoprostol, Blood Loss, Myomectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation

Arm Title

Arm Type

Placebo Comparator

Arm Description

Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation

Intervention Type

Drug

Intervention Name(s)

Rectal Misoprostol

Other Intervention Name(s)

Cytotec

Intervention Description

Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Besix

Intervention Description

Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation

Primary Outcome Measure Information:

Title

Mean intraoperative blood loss in both groups

Time Frame

Within 3 hours

Secondary Outcome Measure Information:

Title

Mean difference of hemoglobin

Time Frame

within 24 hours

Title

Incidence of blood transfusion

Time Frame

within 72 hours

Title

Incidence of unplanned operation

Time Frame

within 72 hours

Title

Incidence of adverse events

Time Frame

within 72 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Rajavithi hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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