An interventional study of Rectal misoprostol in Intraoperative Blood Loss, sponsored by Queen Savang Vadhana Memorial Hospital, Thailand. Completed at 1 site in Thailand. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Queen Savang Vadhana Memorial Hospital, Thailand · Not applicable, Interventional, and Prevention
Comparing of the intraoperative blood loss between group rectal misoprostol group and control group
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 56 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Queen Savang Vadhana Memorial Hospital, Thailand is the lead sponsor of 29 studies on the registry; 15 are open to participants now.
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Female undergoing total abdominal hysterectomy (elective case) with
Exclusion Criteria:
This group received misoprostol transrectally before surgery 1 hour
Drug: Rectal misoprostol
This group not received any drugs before surgery
This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy
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.
Time frame: 7 months
hemoglobin difference
The comparison of hemoglobin between the two groups.
Time frame: 7 months
Blood transfusion
Number of the participants between two groups that receive the blood component during or after the operation
Time frame: 7 months
Number of participants that have side effects of misoprostol
The comparison of frequencies of side effects of misoprostol between the two groups.
Time frame: 7 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Queen Savang Vadhana Memorial Hospital, Thailand