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

NCT ID: NCT05862428

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2022-09-26

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.

Conditions

Intraoperative Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rectal misoprostol

This group received misoprostol transrectally before surgery 1 hour

Group Type: EXPERIMENTAL

Rectal misoprostol

Intervention Type: DRUG

This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy

Control group

This group not received any drugs before surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rectal misoprostol

This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Queen Savang Vadhana Memorial Hospital, Thailand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yingdhanai Pannaraj

Chon Buri, Changwat Chon Buri, Thailand

Countries

Thailand

Other Identifiers

001/2022

Identifier Type: -

Identifier Source: org_study_id