Yingdhanai Pannaraj
Chon Buri, Changwat Chon Buri, 20110, Thailand
NCT Number: NCT05862428
Comparing of the intraoperative blood loss between group rectal misoprostol group and control group
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Female
Interventional
Not applicable
Chon Buri, Changwat Chon Buri, 20110, Thailand
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.
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
Exclusion criteria
This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy
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.
Time frame: 7 months
The comparison of hemoglobin between the two groups.
Time frame: 7 months
Number of the participants between two groups that receive the blood component during or after the operation
Time frame: 7 months
The comparison of frequencies of side effects of misoprostol between the two groups.
Queen Savang Vadhana Memorial Hospital, Thailand
Other
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