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Completed

NCT Number: NCT07380529

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

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.

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Key information

Conditions

Postpartum Hemorrhage (PPH) Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Etlik City Hospital, Ankara, Yenimahalle, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Term pregnancy (>37 weeks gestation)
  • Singleton pregnancy
  • Vertex presentation
  • not having had a cesarean section before
  • emergency cesarean delivery (category 1)
  • low risk for postpartum hemorrhage
  • Vaginal labor has started (> 4 cm cervical dilatation) or a decision has been made (rupture of membranes, Abnormal findings on NST or other signs of fetal compromise.) Exclusion Criteria
  • Non-term pregnancy (< 37 weeks gestation)
  • Non- vertex presentation
  • antenatal high risk pregnancy for postpartum hemorrhage (preeclampsia/eclampsia, previous uterine surgery, placental anomalies)
  • Twin pregnancy
  • Elective cesarean section planned

Treatment and study plan

Carbetocin

Drug

Carbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage

Oxytocin

Drug

Oxytocin administered per institutional standard regimen immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage

Primary outcomes

  1. Postoperative change in hemoglobin at 24 hours

    Time frame: Baseline (preoperative) and within 24 hours after emergency cesarean delivery

    Change in hemoglobin (g/dL) from preoperative baseline to the lowest hemoglobin value within 24 hours after emergency cesarean delivery, compared between the carbetocin and oxytocin groups.

Secondary outcomes

  1. Need for additional uterotonic agents

    Time frame: Within 24 hours after cesarean delivery

    Proportion of participants requiring any additional uterotonic agent(s) within 24 hours after cesarean delivery (after administration of the assigned study drug).

  2. Postoperative change in hematocrit at 24 hours

    Time frame: Baseline (preoperative) and within 24 hours after emergency cesarean delivery

    Change in hematocrit (%) from preoperative baseline to the lowest hematocrit value within 24 hours after emergency cesarean delivery, compared between the carbetocin and oxytocin groups.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Acronym: EMERGE-CS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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