Tranexamic Acid AdministrationTXANCT07870499
Tranexamic Acid for Reducing Blood Loss in High-Risk Cesarean Delivery
A study testing Tranexamic Acid in people with Tranexamic Acid Administration and Postpartum Hemorrhage, run by Mert Yetgin at 1 site in Turkey (Türkiye).
Trial summary
This randomized study evaluated whether prophylactic tranexamic acid (TXA) reduces perioperative blood loss in women at increased risk of postpartum hemorrhage undergoing elective cesarean delivery. Women aged 18-45 years with at least one risk factor for postpartum hemorrhage were included. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Tranexamic Acid Administration, Postpartum Hemorrhage, Blood Transfusion
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2022to 5 Feb 2023
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years
- ASA physical status II
- Gestational age 37-42 weeks
- Scheduled for elective cesarean delivery under spinal or general anesthesia
- Presence of at least one risk factor for postpartum hemorrhage, including:
- Multiple gestation
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- Previous cesarean delivery
- Pregnancy-induced hypertension
- Fetal macrosomia
- Previous postpartum hemorrhage
- Anemia (hemoglobin <10 g/dL)
- Placenta previa
- Placental invasion abnormalities
Who cannot join
- Age <18 years or >45 years
- Refusal to participate in study-related procedures or assessments
- History of cardiovascular disease
- History of cerebrovascular disease
- History of thromboembolic disease
- Coagulopathy
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- Known allergy to any study medication
- Use of low-molecular-weight heparin within 1 week before delivery
- Use of antiplatelet therapy within 1 week before delivery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Hospital
Denizli, Merkezefendi, 20000
About this study
Official title: Effect of Prophylactic Tranexamic Acid on Perioperative Blood Loss in High-Risk Cesarean Delivery: A Randomized Controlled Study
This randomized study evaluated whether prophylactic tranexamic acid (TXA) reduces perioperative blood loss in women at increased risk of postpartum hemorrhage undergoing elective cesarean delivery. Women aged 18-45 years with at least one risk factor for postpartum hemorrhage were included. The anesthesia technique, spinal or general anesthesia, was selected before randomization based on clinical considerations and patient preference. Within each anesthesia group, participants were randomized to receive either 1 g intravenous TXA after umbilical cord clamping or no TXA. The main outcome was estimated blood loss calculated from perioperative hematocrit values. Other outcomes included postpartum hemorrhage, blood transfusion, changes in hemoglobin and hematocrit, need for additional uterotonic medications, adverse events, and thromboembolic events during follow-up.
Read the detailed description
This prospective randomized study was conducted at Pamukkale University Hospital in women undergoing elective cesarean delivery who were considered at increased risk of postpartum hemorrhage. Eligible participants were 18-45 years of age, had American Society of Anesthesiologists physical status II, had a gestational age of 37-42 weeks, and had at least one predefined risk factor for postpartum hemorrhage. These risk factors included multiple gestation, previous cesarean delivery, pregnancy-induced hypertension, fetal macrosomia, previous postpartum hemorrhage, anemia, placenta previa, or placental invasion abnormalities.
The choice of anesthesia technique was not randomized. Spinal or general anesthesia was selected before treatment allocation according to patient preference, obstetric and clinical considerations, and the attending anesthesiologist's judgment. Participants were then stratified according to anesthesia technique. Within each stratum, participants were randomized in a 1:1 ratio to receive either tranexamic acid or no tranexamic acid. This resulted in four study groups: spinal anesthesia with TXA, spinal anesthesia without TXA, general anesthesia with TXA, and general anesthesia without TXA.
After umbilical cord clamping, all participants received standardized oxytocin prophylaxis. Participants assigned to the TXA groups received 1 g intravenous tranexamic acid administered slowly after umbilical cord clamping. Additional uterotonic treatment was given when clinically required according to the study protocol.
The primary outcome was estimated blood loss, calculated using preoperative and postoperative hematocrit values. Postoperative hematocrit was measured at the fourth postoperative hour. Secondary outcomes included the incidence of estimated blood loss greater than 500 mL and greater than 1000 mL, blood transfusion requirement, perioperative changes in hemoglobin and hematocrit, the need for additional uterotonic agents, adverse events potentially associated with TXA, and thromboembolic events during the 3-month follow-up period.
- Conditions
- Tranexamic Acid Administration, Postpartum Hemorrhage, Blood Transfusion, Perioperative Blood Loss, Cesarean Delivery
- Being tested
- Tranexamic Acid
- Keywords
- Tranexamic Acid, Postpartum Hemorrhage, Cesarean Delivery, Perioperative Blood Loss
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Participants assigned to the tranexamic acid groups received 1 g intravenous tranexamic acid administered slowly after umbilical cord clamping, concomitantly with the standardized oxytocin regimen.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia + Tranexamic Acid | Experimental | Participants underwent spinal anesthesia and received 1 g intravenous tranexamic acid slowly after umbilical cord clamping, concomitantly with the standardized oxytocin regimen. Receives: Drug: Tranexamic Acid |
| Spinal Anesthesia + Contro | No intervention | Participants underwent spinal anesthesia and received the standardized oxytocin regimen after umbilical cord clamping without tranexamic acid. |
| General Anesthesia + Tranexamic Acid | Experimental | Participants underwent general anesthesia and received 1 g intravenous tranexamic acid slowly after umbilical cord clamping, concomitantly with the standardized oxytocin regimen. Receives: Drug: Tranexamic Acid |
| General Anesthesia + Control | No intervention | Participants underwent general anesthesia and received the standardized oxytocin regimen after umbilical cord clamping without tranexamic acid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Blood Loss
Estimated blood loss (mL) was calculated using perioperative hematocrit values according to the formula: estimated blood volume × (preoperative hematocrit - postoperative hematocrit) / preoperative hematocrit. Estimated blood volume was calculated as body weight (kg) × 85 mL/kg. Postoperative hematocrit was measured at the fourth postoperative hour.
Measured: Up to 4 hours after cesarean delivery
Secondary outcomes (7)
Incidence of Blood Loss >500 mL
Proportion of participants with estimated blood loss greater than 500 mL.
Measured: Up to 4 hours after cesarean delivery
Incidence of Blood Loss >1000 mL
Proportion of participants with estimated blood loss greater than 1000 mL.
Measured: Up to 4 hours after cesarean delivery
Blood Transfusion Requirement
Number and proportion of participants requiring perioperative blood transfusion.
Measured: During the perioperative hospitalization period
Change in Hemoglobin
Change in hemoglobin concentration from the preoperative value to the postoperative measurement.
Measured: Baseline to 4 hours after cesarean delivery
Additional Uterotonic Requirement
Number and proportion of participants requiring additional uterotonic medication beyond the standardized oxytocin regimen.
Measured: During cesarean delivery and immediate postoperative period
Recorded Adverse Events
Occurrence of headache, fatigue, abdominal pain, nausea, and seizures.
Measured: During the perioperative and postoperative study period.
Thromboembolic Events
Occurrence of thromboembolic events identified during follow-up.
Measured: Up to 3 months after cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start5 Jan 2022
- Primary completion5 Nov 2022
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tranexamic Acid AdministrationStudies 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
- Participants were stratified according to the selected anesthesia technique (spinal or general anesthesia) and then randomized within each stratum in a 1:1 ratio to receive tranexamic acid or no tranexamic acid, resulting in four parallel study groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mert Yetgin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mert Yetgin, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870499
- Sponsor's protocol ID
- bö-1111
- Acronym
- TXA
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study may be shared, including baseline characteristics, treatment allocation, estimated blood loss, hemoglobin and hematocrit values, transfusion requirements, additional uterotonic use, adverse events, and thromboembolic outcomes. Data will be made available upon reasonable request to the corresponding author and subject to applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic Tranexamic Acid on Perioperative Blood Loss in High-Risk Cesarean Delivery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07870499
- Acronym / sponsor ID
- TXA / bö-1111
- Conditions
- Tranexamic Acid Administration, Postpartum Hemorrhage, Blood Transfusion, Perioperative Blood Loss, Cesarean Delivery
- Keywords
- Tranexamic Acid, Postpartum Hemorrhage, Cesarean Delivery, Perioperative Blood Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mert YetginUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 13 Oct 2026 (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.
This randomized study evaluated whether prophylactic tranexamic acid (TXA) reduces perioperative blood loss in women at increased risk of postpartum hemorrhage undergoing elective cesarean delivery. Women aged 18-45 years with at least one risk factor for postpartum hemorrhage were included. The anesthesia technique, spinal or general anesthesia, was selected before randomization based on clinical considerations and patient preference. Within each anesthesia group, participants were randomized to receive either 1 g intravenous TXA after umbilical cord clamping or no TXA. The main outcome was estimated blood loss calculated from perioperative hematocrit values. Other outcomes included postpartum hemorrhage, blood transfusion, changes in hemoglobin and hematocrit, need for additional uterotonic medications, adverse events, and thromboembolic events during follow-up.
Detailed description
This prospective randomized study was conducted at Pamukkale University Hospital in women undergoing elective cesarean delivery who were considered at increased risk of postpartum hemorrhage. Eligible participants were 18-45 years of age, had American Society of Anesthesiologists physical status II, had a gestational age of 37-42 weeks, and had at least one predefined risk factor for postpartum hemorrhage. These risk factors included multiple gestation, previous cesarean delivery, pregnancy-induced hypertension, fetal macrosomia, previous postpartum hemorrhage, anemia, placenta previa, or placental invasion abnormalities.
The choice of anesthesia technique was not randomized. Spinal or general anesthesia was selected before treatment allocation according to patient preference, obstetric and clinical considerations, and the attending anesthesiologist's judgment. Participants were then stratified according to anesthesia technique. Within each stratum, participants were randomized in a 1:1 ratio to receive either tranexamic acid or no tranexamic acid. This resulted in four study groups: spinal anesthesia with TXA, spinal anesthesia without TXA, general anesthesia with TXA, and general anesthesia without TXA.
After umbilical cord clamping, all participants received standardized oxytocin prophylaxis. Participants assigned to the TXA groups received 1 g intravenous tranexamic acid administered slowly after umbilical cord clamping. Additional uterotonic treatment was given when clinically required according to the study protocol.
The primary outcome was estimated blood loss, calculated using preoperative and postoperative hematocrit values. Postoperative hematocrit was measured at the fourth postoperative hour. Secondary outcomes included the incidence of estimated blood loss greater than 500 mL and greater than 1000 mL, blood transfusion requirement, perioperative changes in hemoglobin and hematocrit, the need for additional uterotonic agents, adverse events potentially associated with TXA, and thromboembolic events during the 3-month follow-up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants were stratified according to the selected anesthesia technique (spinal or general anesthesia) and then randomized within each stratum in a 1:1 ratio to receive tranexamic acid or no tranexamic acid, resulting in four parallel study groups.
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia + Tranexamic Acid | Experimental | Drug: Tranexamic AcidParticipants underwent spinal anesthesia and received 1 g intravenous tranexamic acid slowly after umbilical cord clamping, concomitantly with the standardized oxytocin regimen. |
| Spinal Anesthesia + Contro | No intervention | –Participants underwent spinal anesthesia and received the standardized oxytocin regimen after umbilical cord clamping without tranexamic acid. |
| General Anesthesia + Tranexamic Acid | Experimental | Drug: Tranexamic AcidParticipants underwent general anesthesia and received 1 g intravenous tranexamic acid slowly after umbilical cord clamping, concomitantly with the standardized oxytocin regimen. |
| General Anesthesia + Control | No intervention | –Participants underwent general anesthesia and received the standardized oxytocin regimen after umbilical cord clamping without tranexamic acid. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Women aged 18-45 years
- ASA physical status II
- Gestational age 37-42 weeks
- Scheduled for elective cesarean delivery under spinal or general anesthesia
- Presence of at least one risk factor for postpartum hemorrhage, including:
Key exclusion criteria (9 listed)
- Age <18 years or >45 years
- Refusal to participate in study-related procedures or assessments
- History of cardiovascular disease
- History of cerebrovascular disease
- History of thromboembolic disease
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 |
|---|---|---|
| Tranexamic AcidParticipants assigned to the tranexamic acid groups received 1 g intravenous tranexamic acid administered slowly after umbilical cord clamping, concomitantly with the standardized oxytocin regimen. | Drug | General Anesthesia + Tranexamic Acid, Spinal Anesthesia + Tranexamic Acid |
Primary outcome
Estimated Blood Loss
Time frame: Up to 4 hours after cesarean delivery
Estimated blood loss (mL) was calculated using perioperative hematocrit values according to the formula: estimated blood volume × (preoperative hematocrit - postoperative hematocrit) / preoperative hematocrit. Estimated blood volume was calculated as body weight (kg) × 85 mL/kg. Postoperative hematocrit was measured at the fourth postoperative hour.
7 secondary outcomes
Incidence of Blood Loss >500 mL
Time frame: Up to 4 hours after cesarean delivery
Incidence of Blood Loss >1000 mL
Time frame: Up to 4 hours after cesarean delivery
Blood Transfusion Requirement
Time frame: During the perioperative hospitalization period
Change in Hemoglobin
Time frame: Baseline to 4 hours after cesarean delivery
Additional Uterotonic Requirement
Time frame: During cesarean delivery and immediate postoperative period
Recorded Adverse Events
Time frame: During the perioperative and postoperative study period.
Thromboembolic Events
Time frame: Up to 3 months after cesarean delivery
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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study may be shared, including baseline characteristics, treatment allocation, estimated blood loss, hemoglobin and hematocrit values, transfusion requirements, additional uterotonic use, adverse events, and thromboembolic outcomes. Data will be made available upon reasonable request to the corresponding author and subject to applicable ethical and institutional requirements.
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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 Tranexamic Acid in people with Tranexamic Acid Administration and Postpartum Hemorrhage, run by Mert Yetgin 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 13 inclusion and 9 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 16 Oct 2026. 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?
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?
Estimated Blood Loss (time frame: Up to 4 hours after cesarean delivery). 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 16 Oct 2026.