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

Queen Savang Vadhana Memorial Hospital, Thailand

Status: Completed

Conditions: Intraoperative Blood Loss

Treatments: Drug: Rectal misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT05862428

001/2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Rectal misoprostol

Experimental group

Description:

This group received misoprostol transrectally before surgery 1 hour

Treatment:

Drug: Rectal misoprostol

Control group

No Intervention group

Description:

This group not received any drugs before surgery