NCT07380529

Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Ankara Etlik City Hospital · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

This study will be conducted to compare the effects of pabal and oxytocin administered to prevent postpartum hemorrhage in patients who were followed in the delivery room due to vaginal labor but underwent cesarean section due to emergency situations.

Detailed description

The aim of this study is to compare the effectiveness of oxytocin or the long-acting oxytocin analog carbetocin (Pabal) administered to pregnant women to prevent postpartum hemorrhage after emergency cesarean delivery. The primary aim is to evaluate the amount of postpartum bleeding after the use of these two agents and to identify potential risk factors that may change the effectiveness of these drugs. The secondary aim is to observe the changes in intraoperative and postoperative hemodynamic parameters after the administration of these two drugs. According to NICE (National Institute Health and Care) and RCOG (Royal College of Obstetricians and Gynaecologists) guidelines, patients who are in the emergency caesarean category 1 (The life of the mother or baby is in danger. The caesarean should be performed as soon as possible, usually within 30 minutes after the decision is made) group will be included. The aim of this study is to compare the effectiveness of oxytocin or the long-acting oxytocin analog carbetocin (Pabal) administered to pregnant women to prevent postpartum hemorrhage after emergency cesarean delivery. The primary aim is to evaluate the amount of postpartum bleeding after the use of these two agents and to identify potential risk factors that may change the effectiveness of these drugs. The secondary aim is to observe the changes in intraoperative and postoperative hemodynamic parameters after the administration of these two drugs. According to NICE (National Institute Health and Care) and RCOG (Royal College of Obstetricians and Gynaecologists) guidelines, patients who are in the emergency caesarean category 1 (The life of the mother or baby is in danger. The caesarean should be performed as soon as possible, usually within 30 minutes after the decision is made) group will be included. The aim of this study is to compare the effectiveness of oxytocin or the long-acting oxytocin analog carbetocin (Pabal) administered to pregnant women to prevent postpartum hemorrhage after emergency cesarean delivery. The primary aim is to evaluate the amount of postpartum bleeding after the use of these two agents and to identify potential risk factors that may change the effectiveness of these drugs. The secondary aim is to observe the changes in intraoperative and postoperative hemodynamic parameters after the administration of these two drugs. According to NICE (National Institute Health and Care) and RCOG (Royal College of Obstetricians and Gynaecologists) guidelines, patients who are in the emergency caesarean category 1 (The life of the mother or baby is in danger. The caesarean should be performed as soon as possible, usually within 30 minutes after the decision is made) group will be included. Patients are routinely informed about the vaginal delivery process when they come into labor. It was planned to inform the women about the medications planned to be given to prevent postpartum hemorrhage in case of a possible emergency caesarean section and to obtain their written consent. The patient data was designed to be accessible from the hospital information system (Keydata Information Technology Technology Systems), and it was planned to re-check the patient files in order to increase the accuracy and reliability of the data. IBM SPSS Statistics 23.0 (IBM Corp., Armonk, NY, USA) will be used for statistical analysis.

Conditions

• Postpartum Hemorrhage \(PPH\)

Interventions

Type	Name	Description
DRUG	Carbetocin	Carbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage
DRUG	Oxytocin	Oxytocin administered per institutional standard regimen immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-08-04
• Completion: 2025-08-04
• First posted: 2026-02-02
• Last updated: 2026-02-13

Locations

2 sites across 1 country: Turkey (Türkiye)