Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction

Study Overview
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Brief Summary
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Comparing of the intraoperative blood loss between group rectal misoprostol group and control group

Detailed Description
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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.

Official Title
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Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction

Conditions
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Intraoperative Blood Loss

Intervention / Treatment
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* Drug: Rectal misoprostol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rectal misoprostol<br>This group received misoprostol transrectally before surgery 1 hour | Drug: Rectal misoprostol<br>* This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy<br>|
| No Intervention: Control group<br>This group not received any drugs before surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin difference | The comparison of hemoglobin between the two groups. | 7 months | 
| Blood transfusion | Number of the participants between two groups that receive the blood component during or after the operation | 7 months | 
| Number of participants that have side effects of misoprostol | The comparison of frequencies of side effects of misoprostol between the two groups. | 7 months |