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COMPLETED
NCT06970483
PHASE4

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

Sponsor: Ankara Etlik City Hospital

View on ClinicalTrials.gov

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.

Official title: Comparison of the Efficacy of Sublingual Misoprostol and Intravenous Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2023-12-01

Completion Date

2024-12-01

Last Updated

2026-08-05

Healthy Volunteers

Yes

Interventions

DRUG

Tranexamic acid

Transamine1 gram was administered intravenously during the lower segment incision.

DRUG

Misoprostol 200mcg Tab

Cytotec 400 micrograms were administered sublingually immediately after delivery of the baby and clamping of the umbilical cord.

Locations (1)

Etlik City Hospital

Ankara, Turkey (Türkiye)