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

NCT05862428 | Completed DMC

• 1 other identifier: 001/2022
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraoperative Blood Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• hemoglobin difference

  7 months

• Blood transfusion

  7 months

• Number of participants that have side effects of misoprostol

  7 months

Study Arms (2)

Rectal misoprostol

EXPERIMENTAL

This group received misoprostol transrectally before surgery 1 hour

Drug: Rectal misoprostol

Control group

NO INTERVENTION

This group not received any drugs before surgery

Interventions

Rectal misoprostol DRUG

This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy

Rectal misoprostol

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Can not communicate with Thai language
• Malignancy case
• Emergency case

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Yingdhanai Pannaraj

Chon Buri, Changwat Chon Buri, 20110, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants were devided in two groups. The experimental group received rectal misoprostol before surgery and the control group not received the drug

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 17, 2023
• Study Start: February 18, 2022
• Primary Completion: September 26, 2022
• Study Completion: September 26, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)