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Completed

NCT Number: NCT05862428

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

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

Completed

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yingdhanai Pannaraj

Chon Buri, Changwat Chon Buri, 20110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rectal Misoprostol

Drug

This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy

Primary outcomes

  1. Intraoperative blood loss

    Time frame: 7 months

    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.

Secondary outcomes

  1. hemoglobin difference

    Time frame: 7 months

    The comparison of hemoglobin between the two groups.

  2. Blood transfusion

    Time frame: 7 months

    Number of the participants between two groups that receive the blood component during or after the operation

  3. Number of participants that have side effects of misoprostol

    Time frame: 7 months

    The comparison of frequencies of side effects of misoprostol between the two groups.

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 17, 2023
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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