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Completed NCT06970483

Comparison of the Efficacy of Misoprostol and Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery

Conditions: Postpartum Hemorrhage, Cesarean Section Complications, Delivery Complication

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 192
Sponsor: Ankara Etlik City Hospital

Location: Etlik City Hospital Ankara

Summary

Postpartum hemorrhage (PPH) is an obstetric emergency, with an estimated incidence ranging from 2.8% to 7.9%. Recent studies indicate an increasing trend in the frequency of PPH.Although it is more commonly seen in developing countries, it remains a significant cause of maternal morbidity and mortality worldwide. Therefore, early diagnosis and prompt, accurate intervention are critically important. Despite the rising incidence of PPH, maternal mortality rates have declined. This improvement is largely attributed to better identification of risk factors, timely diagnosis, and effective intervention. To prevent PPH globally, active management of the third stage of labor has been widely implemented. This approach includes the use of pharmacologic agents, uterine massage, and controlled traction for placental delivery.Among pharmacological agents, the most commonly used include oxytocin, ergot alkaloids (e.g., ergometrine), tranexamic acid, prostaglandin E1 (misoprostol), prostaglandin F2α, and oxytocin analogues (e.g., carbetocin).Oxytocin is the most widely used agent for PPH prophylaxis. The aim of this study is to compare the efficacy of tranexamic acid and misoprostol in the prophylaxis of postpartum hemorrhage.

Eligibility Criteria

Inclusion Criteria: Patients aged 18-45 years Gestational age between 37 and 41 weeks Prior cesarean delivery (repeat elective cesarean section) Performed cesarean section for delivery Exclusion Criteria: * did not provide informed consent, * with comorbidities (such as heart, liver, or lung diseases), * high-risk pregnancy (e.g., intrauterine growth restriction, cholestasis, preeclampsia, eclampsia, multiple pregnancies) * known allergies to tranexamic acid or misoprostol * known coagulation disorders

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06970483). StuddyBuddy aggregates publicly available trial information.