Cesarean DeliveryNCT07390799
Prophylactic Tranexamic Acid in Low-Risk Repeat Cesarean Delivery: A Randomized Controlled Trial
A study testing Tranexamic Acid in people with Cesarean Delivery, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Postpartum hemorrhage remains a leading cause of maternal morbidity following cesarean delivery. Tranexamic acid (TXA) has been shown to reduce blood loss when used for the treatment of postpartum hemorrhage; however, its routine prophylactic use during cesarean delivery, particularly in low-risk women, remains… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Delivery
- 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
- 204 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years Singleton pregnancy Gestational age ≥37+0 weeks Scheduled second or third cesarean delivery Classified as low risk for postpartum hemorrhage Ability to provide written informed consent Planned cesarean delivery under regional or general anesthesia
Who cannot join
- Primary cesarean delivery More than three previous cesarean deliveries Placenta previa, placenta accreta spectrum, or suspected abnormal placentation Multiple pregnancy Known coagulation disorders or use of anticoagulant therapy History of thromboembolic disease Severe anemia (hemoglobin <10 g/dL) Hypertensive disorders of pregnancy (including preeclampsia or eclampsia) Intrauterine fetal demise Emergency cesarean delivery Known hypersensitivity to tranexamic acid
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir Bakircay University
Izmir, Menemen, 35665
Sabahattin A Arı, Associate Professor, +905547139994, s.anil.ari.md@gmail.com
About this study
Official title: Effect of Prophylactic Tranexamic Acid Administered After Fetal Delivery on Perioperative Blood Loss and Neonatal Outcomes in Low-Risk Repeat Cesarean Delivery: A Randomized Controlled Trial
Postpartum hemorrhage remains a leading cause of maternal morbidity following cesarean delivery. Tranexamic acid (TXA) has been shown to reduce blood loss when used for the treatment of postpartum hemorrhage; however, its routine prophylactic use during cesarean delivery, particularly in low-risk women, remains controversial. Large randomized trials have demonstrated limited benefit on major maternal outcomes, and data regarding clinically meaningful blood loss reduction and neonatal safety are still inconclusive.
This randomized controlled trial aims to evaluate the effect of prophylactic tranexamic acid administered after fetal delivery on perioperative blood loss in women undergoing low-risk repeat cesarean delivery. Secondary objectives include the assessment of neonatal outcomes to further evaluate the safety of routine TXA administration in this population.
The results of this study are expected to provide evidence to inform clinical decision-making regarding the routine use of tranexamic acid in low-risk repeat cesarean deliveries, balancing potential maternal benefits against neonatal safety considerations.
Read the detailed description
Postpartum hemorrhage remains one of the leading causes of maternal morbidity worldwide, and cesarean delivery is associated with a higher risk of perioperative blood loss compared with vaginal birth. Tranexamic acid (TXA), a synthetic antifibrinolytic agent, is well established for the treatment of postpartum hemorrhage. However, the role of routine prophylactic TXA administration during cesarean delivery remains controversial, particularly in women without established risk factors for excessive bleeding.
Recent large randomized trials have demonstrated that prophylactic TXA administered after fetal delivery may reduce measured blood loss but does not significantly improve major maternal outcomes such as the need for blood transfusion or maternal mortality in unselected cesarean populations. Furthermore, data regarding the clinical relevance of modest reductions in blood loss and the potential impact on neonatal outcomes remain limited.
This randomized controlled trial is designed to evaluate the effect of prophylactic tranexamic acid administered after fetal delivery on perioperative blood loss in women undergoing low-risk repeat cesarean delivery. The study focuses on women undergoing their second or third cesarean section without additional risk factors for postpartum hemorrhage, representing a clinically common yet understudied population.
Participants will be randomized in a 1:1 ratio to receive either intravenous tranexamic acid (1 g) administered immediately after fetal delivery or standard care without tranexamic acid. All participants will receive standardized surgical technique and uterotonic management according to institutional protocols. Perioperative blood loss will be measured using standardized methods. A difference of 200 mL in perioperative blood loss is considered clinically meaningful for the purposes of this study.
In addition to maternal outcomes, neonatal outcomes will be prospectively assessed to evaluate the safety of routine prophylactic TXA administration when given after fetal delivery. Neonatal assessments will include immediate postnatal adaptation, need for resuscitation, admission to the neonatal intensive care unit, and selected laboratory and clinical outcomes during the early neonatal period.
By focusing on a homogeneous low-risk repeat cesarean population and incorporating both maternal and neonatal outcomes, this study aims to clarify whether routine prophylactic tranexamic acid use provides clinically meaningful benefit without compromising neonatal safety. The findings are expected to inform evidence-based decision-making regarding the routine use of tranexamic acid in low-risk repeat cesarean delivery.
- Conditions
- Cesarean Delivery
- Being tested
- Tranexamic Acid
- Keywords
- Tranexamic Acid, Repeat Cesarean Section, Perioperative Blood Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Tranexamic acid 1 g will be administered intravenously as a single dose immediately after fetal delivery during cesarean section, in addition to standard surgical and uterotonic management.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid Group | Experimental | Participants randomized to this arm will receive a single dose of tranexamic acid (1 g) administered intravenously immediately after fetal delivery during cesarean section, in addition to standard surgical and uterotonic management. Receives: Drug: Tranexamic Acid |
| Control Group | No intervention | Participants randomized to this arm will receive standard surgical and uterotonic management during cesarean section without the administration of tranexamic acid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative blood loss (mL)
Perioperative blood loss will be quantified using standardized measurement methods during cesarean delivery. A difference of 200 mL in perioperative blood loss between groups is considered clinically meaningful.
Measured: From skin incision until completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies 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
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Anıl Arı, Ege University
- Investigators
- Sabahattin Anıl A ARI, Associate Professor, Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390799
- Sponsor's protocol ID
- 2517
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic Tranexamic Acid Administered After Fetal Delivery on Perioperative Blood Loss and Neonatal Outcomes in Low-Risk Repeat Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07390799
- Acronym / sponsor ID
- 2517
- Conditions
- Cesarean Delivery
- Keywords
- Tranexamic Acid, Repeat Cesarean Section, Perioperative Blood Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 5 Feb 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.
Postpartum hemorrhage remains a leading cause of maternal morbidity following cesarean delivery. Tranexamic acid (TXA) has been shown to reduce blood loss when used for the treatment of postpartum hemorrhage; however, its routine prophylactic use during cesarean delivery, particularly in low-risk women, remains controversial. Large randomized trials have demonstrated limited benefit on major maternal outcomes, and data regarding clinically meaningful blood loss reduction and neonatal safety are still inconclusive.
This randomized controlled trial aims to evaluate the effect of prophylactic tranexamic acid administered after fetal delivery on perioperative blood loss in women undergoing low-risk repeat cesarean delivery. Secondary objectives include the assessment of neonatal outcomes to further evaluate the safety of routine TXA administration in this population.
The results of this study are expected to provide evidence to inform clinical decision-making regarding the routine use of tranexamic acid in low-risk repeat cesarean deliveries, balancing potential maternal benefits against neonatal safety considerations.
Detailed description
Postpartum hemorrhage remains one of the leading causes of maternal morbidity worldwide, and cesarean delivery is associated with a higher risk of perioperative blood loss compared with vaginal birth. Tranexamic acid (TXA), a synthetic antifibrinolytic agent, is well established for the treatment of postpartum hemorrhage. However, the role of routine prophylactic TXA administration during cesarean delivery remains controversial, particularly in women without established risk factors for excessive bleeding.
Recent large randomized trials have demonstrated that prophylactic TXA administered after fetal delivery may reduce measured blood loss but does not significantly improve major maternal outcomes such as the need for blood transfusion or maternal mortality in unselected cesarean populations. Furthermore, data regarding the clinical relevance of modest reductions in blood loss and the potential impact on neonatal outcomes remain limited.
This randomized controlled trial is designed to evaluate the effect of prophylactic tranexamic acid administered after fetal delivery on perioperative blood loss in women undergoing low-risk repeat cesarean delivery. The study focuses on women undergoing their second or third cesarean section without additional risk factors for postpartum hemorrhage, representing a clinically common yet understudied population.
Participants will be randomized in a 1:1 ratio to receive either intravenous tranexamic acid (1 g) administered immediately after fetal delivery or standard care without tranexamic acid. All participants will receive standardized surgical technique and uterotonic management according to institutional protocols. Perioperative blood loss will be measured using standardized methods. A difference of 200 mL in perioperative blood loss is considered clinically meaningful for the purposes of this study.
In addition to maternal outcomes, neonatal outcomes will be prospectively assessed to evaluate the safety of routine prophylactic TXA administration when given after fetal delivery. Neonatal assessments will include immediate postnatal adaptation, need for resuscitation, admission to the neonatal intensive care unit, and selected laboratory and clinical outcomes during the early neonatal period.
By focusing on a homogeneous low-risk repeat cesarean population and incorporating both maternal and neonatal outcomes, this study aims to clarify whether routine prophylactic tranexamic acid use provides clinically meaningful benefit without compromising neonatal safety. The findings are expected to inform evidence-based decision-making regarding the routine use of tranexamic acid in low-risk repeat cesarean delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Group | Experimental | Drug: Tranexamic AcidParticipants randomized to this arm will receive a single dose of tranexamic acid (1 g) administered intravenously immediately after fetal delivery during cesarean section, in addition to standard surgical and uterotonic management. |
| Control Group | No intervention | –Participants randomized to this arm will receive standard surgical and uterotonic management during cesarean section without the administration of tranexamic acid. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 18 to 45 years Singleton pregnancy Gestational age ≥37+0 weeks Scheduled second or third cesarean delivery Classified as low risk for postpartum hemorrhage Ability to provide written informed consent Planned cesarean delivery under regional or general anesthesia
Key exclusion criteria (1 listed)
- Primary cesarean delivery More than three previous cesarean deliveries Placenta previa, placenta accreta spectrum, or suspected abnormal placentation Multiple pregnancy Known coagulation disorders or use of anticoagulant therapy History of thromboembolic disease Severe anemia (hemoglobin <10 g/dL) Hypertensive disorders of pregnancy (including preeclampsia or eclampsia) Intrauterine fetal demise Emergency cesarean delivery Known hypersensitivity to tranexamic acid
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 AcidTranexamic acid 1 g will be administered intravenously as a single dose immediately after fetal delivery during cesarean section, in addition to standard surgical and uterotonic management. | Drug | Tranexamic Acid Group |
Primary outcome
Perioperative blood loss (mL)
Time frame: From skin incision until completion of surgery
Perioperative blood loss will be quantified using standardized measurement methods during cesarean delivery. A difference of 200 mL in perioperative blood loss between groups is considered clinically meaningful.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sabahattin Anıl A ARI, Associate Professor principal investigator
Izmir Bakircay University
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 Cesarean Delivery, run by Ege University 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabahattin A Arı, Associate Professor (+905547139994, s.anil.ari.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood loss (mL) (time frame: From skin incision until completion of surgery). 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 5 Feb 2026.