Hemorrhage, SurgicalNCT06114758
Comparison Effectiveness of Rectal Misoprostol & Intravenous Tranexamic Acid Reducing Hemorrhage in Myomectomy
An observational study of Hemorrhage, Surgical and Myoma;Uterus, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Fibroids are the most commonly encountered tumors in the female reproductive system. In patients, fibroids most often lead to abnormal uterine bleeding and the resulting anemia. In some cases, they can cause infertility or habitual abortions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hemorrhage, Surgical, Myoma;Uterus, Effect of Drug
- What is being tested?
- Cytotec 200Mcg Tablet and Transamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Nov 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: In our study, data of patients admitted with a diagnosis of uterine fibroids to the Department of Obstetrics and Gynecology, Women's Health and Obstetrics (Etlik City Hospital) between October 1, 2023, and October 1, 2024, who underwent myomectomy (either laparotomic or laparoscopic), will be collected prospectively
Who may be able to join
- Patients over 18 years of age
- Laparotomic myomectomy surgeries
- Laparoscopic myomectomy surgeries
Who cannot join
- Identifying missing or suspicious data related to the patient
- Administering both intraoperative and postoperative medications to the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of the Effectiveness of Rectal Misoprostol and Intravenous Tranexamic Acid in Reducing Intraoperative Bleeding in Patients Undergoing Myomectomy
Fibroids are the most commonly encountered tumors in the female reproductive system. In patients, fibroids most often lead to abnormal uterine bleeding and the resulting anemia. In some cases, they can cause infertility or habitual abortions. Another complaint caused by fibroids is pain due to pressure and effects on adjacent organs. Very large fibroids can lead to abdominal swelling. Therefore, if a patient becomes symptomatic due to fibroids, myomectomy or, if necessary, hysterectomy is required.
Because fibroids have a significant blood supply, there is a high risk of intraoperative bleeding and related complications. Additionally, the most common complication in these patients after the operation is bleeding. In many of these patients, intraoperative or postoperative blood transfusions are performed. If bleeding cannot be intervened early in these patients, hemodynamic instability, shock, coagulopathy, and, in the final stage, death can occur due to hemorrhage. Therefore, both intraoperative and postoperative bleeding control is of vital importance in patients undergoing myomectomy.
Read the detailed description
In this study, data of patients admitted with a diagnosis of uterine fibroids to the Department of Obstetrics and Gynecology, Women's Health and Obstetrics (EŞH) between September 1, 2022, and Sempember 1, 2024, who underwent myomectomy (either laparotomic or laparoscopic), will be collected.
The parameters to be examined in the research are as follows:
- Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation).
- Shock indices.
- Hemogram and hematocrit values at 6-24 hours postoperatively.
- Duration of the surgery.
- Adverse effects experienced by the patients.
- Additional treatments administered.
- Whether blood transfusion was performed or not.
In this study, the G-power analysis program was used to determine the minimum sample size, taking into account a 10% margin of error. According to the analysis results, the minimum number of patients to be included in the study for a total of 75 patients across 3 groups was determined. Statistical analysis of the data obtained in the study will be conducted using the SPSS Statistics 22 software package. A 95% confidence interval will be calculated for each variable, and results will be considered statistically significant for p < 0.05.
- Conditions
- Hemorrhage, Surgical, Myoma;Uterus, Effect of Drug, Postoperative Hemorrhage, Postoperative Complications
- Being tested
- Cytotec 200Mcg Tablet, Transamine
- Keywords
- myoma uteri, fibroids, hemmorhage, prostoglandinf2α, tranexamic acid
- Medical subject headings
- Blood Loss, Surgical, Myofibroma, Postoperative Hemorrhage, Postoperative Complications, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytotec 200Mcg TabletDrug
Also called misoprostol, prostoglandin f2α
the admistiration of 400 Mcg rectal cytotec while starting the surgery, just before the patient is covered
TransamineDrug
Also called tranexamic acid
1 gram intravenous slow infusion intraoperatively as we start the laparatomy
| Study group | Role | What they receive |
|---|---|---|
| control group - group 1 | 1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation). 2. Shock indices. 3. Hemogram and hematocrit values at 6-24 hours postoperatively. 4. Duration of the surgery. 5. Adverse effects experienced by the patients. 6. Additional treatments administered. 7. Whether blood transfusion was performed or not. | |
| intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2 | 1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation).
2. Shock indices.
3. Hemogram and hematocrit values at 6-24 hours postoperatively.
4. Duration of the surgery.
5. Adverse effects experienced by the patients.
6. Additional treatments administered.
7. Whether blood transfusion was performed or not. Receives: Drug: Transamine | |
| intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2 | 1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation).
2. Shock indices.
3. Hemogram and hematocrit values at 6-24 hours postoperatively.
4. Duration of the surgery.
5. Adverse effects experienced by the patients.
6. Additional treatments administered.
7. Whether blood transfusion was performed or not. Receives: Drug: Cytotec 200Mcg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patients' preoperative and postoperative hemogram levels
The basal hemogram levels ( gr/dL) of the patients will be compared with the hemogram levels at 6 and 24 hours.
Measured: 24 hours
Comparison of patients' preoperative and postoperative hematocrit levels
The basal hematocrit levels (%) of the patients will be compared with the hematocrit levels at 6 and 24 hours.
Measured: 24 hours
Comparison of patients' postoperative shock indices
postoperative 1st, 2nd, and 6th-hour shock indices (heart rate (beats in minute) / systolic blood pressure(mmHg) ) will be compared
Measured: 6 hour
Secondary outcomes (2)
Comparison of the patients' postoperative heart rate
Patients postoperative 1st, 2nd, and 6th-hour heart rate (beats in minute) will be compared
Measured: 6 hour
Comparison of the patients' postoperative systolic and diastolic blood pressure
Patients postoperative 1st, 2nd, and 6th-hour systolic and diastolic blood pressure (mmHg) will be compared
Measured: 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhage, SurgicalStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuğba Ağbal, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114758
- Sponsor's protocol ID
- AEŞH-EK1-2023-383
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 2 Nov 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Effectiveness of Rectal Misoprostol and Intravenous Tranexamic Acid in Reducing Intraoperative Bleeding in Patients Undergoing Myomectomy
- ClinicalTrials.gov ID
- NCT06114758
- Acronym / sponsor ID
- AEŞH-EK1-2023-383
- Conditions
- Hemorrhage, Surgical, Myoma;Uterus, Effect of Drug, Postoperative Hemorrhage, Postoperative Complications
- Keywords
- myoma uteri, fibroids, hemmorhage, prostoglandinf2α, tranexamic acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 2 Nov 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.
Fibroids are the most commonly encountered tumors in the female reproductive system. In patients, fibroids most often lead to abnormal uterine bleeding and the resulting anemia. In some cases, they can cause infertility or habitual abortions. Another complaint caused by fibroids is pain due to pressure and effects on adjacent organs. Very large fibroids can lead to abdominal swelling. Therefore, if a patient becomes symptomatic due to fibroids, myomectomy or, if necessary, hysterectomy is required.
Because fibroids have a significant blood supply, there is a high risk of intraoperative bleeding and related complications. Additionally, the most common complication in these patients after the operation is bleeding. In many of these patients, intraoperative or postoperative blood transfusions are performed. If bleeding cannot be intervened early in these patients, hemodynamic instability, shock, coagulopathy, and, in the final stage, death can occur due to hemorrhage. Therefore, both intraoperative and postoperative bleeding control is of vital importance in patients undergoing myomectomy.
Detailed description
In this study, data of patients admitted with a diagnosis of uterine fibroids to the Department of Obstetrics and Gynecology, Women's Health and Obstetrics (EŞH) between September 1, 2022, and Sempember 1, 2024, who underwent myomectomy (either laparotomic or laparoscopic), will be collected.
The parameters to be examined in the research are as follows:
- Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation).
- Shock indices.
- Hemogram and hematocrit values at 6-24 hours postoperatively.
- Duration of the surgery.
- Adverse effects experienced by the patients.
- Additional treatments administered.
- Whether blood transfusion was performed or not.
In this study, the G-power analysis program was used to determine the minimum sample size, taking into account a 10% margin of error. According to the analysis results, the minimum number of patients to be included in the study for a total of 75 patients across 3 groups was determined. Statistical analysis of the data obtained in the study will be conducted using the SPSS Statistics 22 software package. A 95% confidence interval will be calculated for each variable, and results will be considered statistically significant for p < 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group - group 1 | – | –1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation). 2. Shock indices. 3. Hemogram and hematocrit values at 6-24 hours postoperatively. 4. Duration of the surgery. 5. Adverse effects experienced by the patients. 6. Additional treatments administered. 7. Whether blood transfusion was performed or not. |
| intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2 | – | Drug: Transamine1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation). 2. Shock indices. 3. Hemogram and hematocrit values at 6-24 hours postoperatively. 4. Duration of the surgery. 5. Adverse effects experienced by the patients. 6. Additional treatments administered. 7. Whether blood transfusion was performed or not. |
| intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2 | – | Drug: Cytotec 200Mcg Tablet1. Patients' postoperative 1st, 2nd, and 6th-hour vital signs (pulse rate, systolic and diastolic blood pressure, temperature, oxygen saturation). 2. Shock indices. 3. Hemogram and hematocrit values at 6-24 hours postoperatively. 4. Duration of the surgery. 5. Adverse effects experienced by the patients. 6. Additional treatments administered. 7. Whether blood transfusion was performed or not. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- In our study, data of patients admitted with a diagnosis of uterine fibroids to the Department of Obstetrics and Gynecology, Women's Health and Obstetrics (Etlik City Hospital) between October 1, 2023, and October 1, 2024, who underwent myomectomy (either laparotomic or laparoscopic), will be collected prospectively
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Laparotomic myomectomy surgeries
- Laparoscopic myomectomy surgeries
Key exclusion criteria (2 listed)
- Identifying missing or suspicious data related to the patient
- Administering both intraoperative and postoperative medications to the patient
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 |
|---|---|---|
| Cytotec 200Mcg TabletAlso: misoprostol, prostoglandin f2αthe admistiration of 400 Mcg rectal cytotec while starting the surgery, just before the patient is covered | Drug | intraoperatively admistiration of prostoglandin f2 alfa (cytotec 400 microgram rectal)- group 2 |
| TransamineAlso: tranexamic acid1 gram intravenous slow infusion intraoperatively as we start the laparatomy | Drug | intraoperatively admistiration of tranexamic acid (1 gram intravenous) - group 2 |
Primary outcome
Comparison of patients' preoperative and postoperative hemogram levels
Time frame: 24 hours
The basal hemogram levels ( gr/dL) of the patients will be compared with the hemogram levels at 6 and 24 hours.
Comparison of patients' preoperative and postoperative hematocrit levels
Time frame: 24 hours
The basal hematocrit levels (%) of the patients will be compared with the hematocrit levels at 6 and 24 hours.
Comparison of patients' postoperative shock indices
Time frame: 6 hour
postoperative 1st, 2nd, and 6th-hour shock indices (heart rate (beats in minute) / systolic blood pressure(mmHg) ) will be compared
2 secondary outcomes
Comparison of the patients' postoperative heart rate
Time frame: 6 hour
Comparison of the patients' postoperative systolic and diastolic blood pressure
Time frame: 6 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 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?
An observational study of Hemorrhage, Surgical and Myoma;Uterus, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Nov 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Comparison of patients' preoperative and postoperative hemogram levels (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 2 Nov 2023.