Intraoperative Blood LossNCT05862428
Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction
A study testing Rectal misoprostol in people with Intraoperative Blood Loss, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial summary
Comparing of the intraoperative blood loss between group rectal misoprostol group and control group Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Intraoperative Blood Loss
- What is being tested?
- Rectal misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteThailand
- Study dates
- 18 Feb 2022to 26 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Can not communicate with Thai language
- Malignancy case
- Emergency case
Trial locations and contacts
1 site in 1 country.
About this study
Comparing of the intraoperative blood loss between group rectal misoprostol group and control group
Read the detailed 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.
- Conditions
- Intraoperative Blood Loss
- Being tested
- Rectal misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal misoprostolDrug
This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Rectal misoprostol | Experimental | This group received misoprostol transrectally before surgery 1 hour Receives: Drug: Rectal misoprostol |
| Control group | No intervention | This group not received any drugs before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Secondary outcomes (3)
hemoglobin difference
The comparison of hemoglobin between the two groups.
Measured: 7 months
Blood transfusion
Number of the participants between two groups that receive the blood component during or after the operation
Measured: 7 months
Number of participants that have side effects of misoprostol
The comparison of frequencies of side effects of misoprostol between the two groups.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start18 Feb 2022
- Primary completion26 Sep 2022
- Study completion26 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Blood LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were devided in two groups. The experimental group received rectal misoprostol before surgery and the control group not received the drug
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862428
- Sponsor's protocol ID
- 001/2022
- Status last verified
- May 2023
- First submitted
- 23 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction
- ClinicalTrials.gov ID
- NCT05862428
- Acronym / sponsor ID
- 001/2022
- Conditions
- Intraoperative Blood Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing of the intraoperative blood loss between group rectal misoprostol group and control group
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were devided in two groups. The experimental group received rectal misoprostol before surgery and the control group not received the drug
| Arm | Type | Receives |
|---|---|---|
| Rectal misoprostol | Experimental | Drug: Rectal misoprostolThis group received misoprostol transrectally before surgery 1 hour |
| Control group | No intervention | –This group not received any drugs before surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Can not communicate with Thai language
- Malignancy case
- Emergency case
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal misoprostolThis intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy | Drug | Rectal misoprostol |
Primary outcome
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.
3 secondary outcomes
hemoglobin difference
Time frame: 7 months
Blood transfusion
Time frame: 7 months
Number of participants that have side effects of misoprostol
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal misoprostol in people with Intraoperative Blood Loss, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.