An interventional study of Tranexamic Acid in Tranexamic Acid Administration, Postpartum Hemorrhage and Blood Transfusion, sponsored by Mert Yetgin. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Mert Yetgin · Not applicable, Interventional, and Prevention
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.
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.
456 studies on the registry are indexed under Postpartum Hemorrhage; 77 are open to participants now.
This study's enrollment of 84 is below the median of 148 across 348 interventional studies indexed under Postpartum Hemorrhage.
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Exclusion Criteria:
Participants underwent spinal anesthesia and received 1 g intravenous tranexamic acid slowly after umbilical cord clamping, concomitantly with the standardized oxytocin regimen.
Drug: Tranexamic Acid
Participants underwent spinal anesthesia and received the standardized oxytocin regimen after umbilical cord clamping without tranexamic acid.
Participants underwent general anesthesia and received 1 g intravenous tranexamic acid slowly after umbilical cord clamping, concomitantly with the standardized oxytocin regimen.
Drug: Tranexamic Acid
Participants underwent general anesthesia and received the standardized oxytocin regimen after umbilical cord clamping without tranexamic acid.
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.
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.
Time frame: Up to 4 hours after cesarean delivery
Incidence of Blood Loss >500 mL
Proportion of participants with estimated blood loss greater than 500 mL.
Time frame: Up to 4 hours after cesarean delivery
Incidence of Blood Loss >1000 mL
Proportion of participants with estimated blood loss greater than 1000 mL.
Time frame: Up to 4 hours after cesarean delivery
Blood Transfusion Requirement
Number and proportion of participants requiring perioperative blood transfusion.
Time frame: During the perioperative hospitalization period
Change in Hemoglobin
Change in hemoglobin concentration from the preoperative value to the postoperative measurement.
Time frame: Baseline to 4 hours after cesarean delivery
Additional Uterotonic Requirement
Number and proportion of participants requiring additional uterotonic medication beyond the standardized oxytocin regimen.
Time frame: During cesarean delivery and immediate postoperative period
Recorded Adverse Events
Occurrence of headache, fatigue, abdominal pain, nausea, and seizures.
Time frame: During the perioperative and postoperative study period.
Thromboembolic Events
Occurrence of thromboembolic events identified during follow-up.
Time frame: Up to 3 months after cesarean delivery
Plan to share: 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.
Time frame: De-identified individual participant data will be available after publication of the study results and will remain available for 5 years following publication.
Access criteria: De-identified individual participant data may be provided to qualified researchers who submit a scientifically reasonable request to the corresponding author. Requests should include the purpose of the proposed analysis and the data required. Access will be subject to appropriate ethical and institutional considerations and approval by the study investigators.
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Ran from Jan 2022 to primary completion in Nov 2022, 10 months.
Of 102 non-industry interventional studies with no phase under Postpartum Hemorrhage, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 26. This study's 10 months is below that.
Counting every sponsor, half of 109 studies reached it within 12 months; a quarter within 6 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid