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

Intraoperative Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862428
• Other study ID #: 001/2022
• Status: Completed
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: September 26, 2022

Study information

• Verified date: May 2023
• Source: Queen Savang Vadhana Memorial Hospital, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing of the intraoperative blood loss between group rectal misoprostol group and control group

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 26, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intraoperative Blood Loss

Intervention

Drug:
• Rectal misoprostol
This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy

Locations

Country	Name	City	State
Thailand	Yingdhanai Pannaraj	Chon Buri	Chonburi

Sponsors (1)

Lead Sponsor	Collaborator
Queen Savang Vadhana Memorial Hospital, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	hemoglobin difference	The comparison of hemoglobin between the two groups.	7 months
Secondary	Blood transfusion	Number of the participants between two groups that receive the blood component during or after the operation	7 months
Secondary	Number of participants that have side effects of misoprostol	The comparison of frequencies of side effects of misoprostol between the two groups.	7 months