Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction
Primary Purpose
Intraoperative Blood Loss
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Rectal misoprostol
Sponsored by

About this trial
This is an interventional prevention trial for Intraoperative Blood Loss
Eligibility Criteria
Inclusion Criteria: Female undergoing total abdominal hysterectomy (elective case) with No history of bleeding tendency No history of anticoagulant drug used within 7 days before surgery No contraindications of Misoprostol drug used No history of allergic to misoprostol Exclusion Criteria: Can not communicate with Thai language Malignancy case Emergency case
Sites / Locations
- Yingdhanai Pannaraj
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rectal misoprostol
Control group
Arm Description
This group received misoprostol transrectally before surgery 1 hour
This group not received any drugs before surgery
Outcomes
Primary Outcome Measures
Intraoperative blood loss
The intraoperative blood loss was defined as the blood at starting with a cut in the skin until the suture is closed. Its quantity was measure from blood pads and was record in millilitres. One gram of the blood was 1 ml.
Secondary Outcome Measures
hemoglobin difference
The comparison of hemoglobin between the two groups.
Blood transfusion
Number of the participants between two groups that receive the blood component during or after the operation
Number of participants that have side effects of misoprostol
The comparison of frequencies of side effects of misoprostol between the two groups.
Full Information
NCT ID
NCT05862428
First Posted
April 23, 2023
Last Updated
May 7, 2023
Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT05862428
Brief Title
Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction
Official Title
Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
September 26, 2022 (Actual)
Study Completion Date
September 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparing of the intraoperative blood loss between group rectal misoprostol group and control group
Detailed Description
This open-labeled randomized controlled trial was conducted at the Department of Obstetrics and Gynecology, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand, from February 2022 to September 2022, after approval of the Institution of Review Board of Queen Savang Vadhana Memorial Hospital (IRB No. 001/2565).
Fifty six (56) women with diagnosis of benign uterine disease who were scheduled to perform total abdominal hysterectomy with or without bilateral salpingo-oophorectomy between February 2022 to September 2022 at Queen Savang Vadhana Memorial Hospital were enrolled in this study.
The participants were randomly allocated into two groups, study and control group. The randomization list was kept in a sealed opaque envelope. Study group received two tablets of 200 mcg misoprostol; The drug was inserted rectally 1 hour before operation. Few drops of normal saline were used to dissolve tablets before insertion. Control group that did not receive the drug. The drug was administered by a nurse at Gynecologic ward. The primary outcome was intraoperative blood loss that recorded by measuring amount of blood on the surgical gauzes and swabs by standardized scales and another was recorded from blood in suction container. The secondary outcome was hemoglobin differentiation, rate of blood transfusion and adverse events of misoprostol usage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Blood Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants were devided in two groups. The experimental group received rectal misoprostol before surgery and the control group not received the drug
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rectal misoprostol
Arm Type
Experimental
Arm Description
This group received misoprostol transrectally before surgery 1 hour
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group not received any drugs before surgery
Intervention Type
Drug
Intervention Name(s)
Rectal misoprostol
Intervention Description
This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
The intraoperative blood loss was defined as the blood at starting with a cut in the skin until the suture is closed. Its quantity was measure from blood pads and was record in millilitres. One gram of the blood was 1 ml.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
hemoglobin difference
Description
The comparison of hemoglobin between the two groups.
Time Frame
7 months
Title
Blood transfusion
Description
Number of the participants between two groups that receive the blood component during or after the operation
Time Frame
7 months
Title
Number of participants that have side effects of misoprostol
Description
The comparison of frequencies of side effects of misoprostol between the two groups.
Time Frame
7 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female undergoing total abdominal hysterectomy (elective case) with
No history of bleeding tendency
No history of anticoagulant drug used within 7 days before surgery
No contraindications of Misoprostol drug used
No history of allergic to misoprostol
Exclusion Criteria:
Can not communicate with Thai language
Malignancy case
Emergency case
Facility Information:
Facility Name
Yingdhanai Pannaraj
City
Chon Buri
State/Province
Chonburi
ZIP/Postal Code
20110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction
We'll reach out to this number within 24 hrs