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

February 12, 2026 updated by: Tahir Eryılmaz, Ankara Etlik City Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06170
        • Etlik City Hospital
      • Ankara, Yenimahalle, Turkey (Türkiye), 06010
        • Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin
Standard oxytocin regimen after delivery (uterotonic prophylaxis at emergency cesarean)
Drug: Oxytocin
Oxytocin administered per institutional standard regimen immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage
Experimental: carbetocin
Carbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage
Drug: Carbetocin
Carbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (preoperative) and within 24 hours after emergency cesarean delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 24 hours after cesarean delivery
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.
Baseline (preoperative) and within 24 hours after emergency cesarean delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Investigators

  • Principal Investigator: TAHİR ERYILMAZ, M.D. Dr., Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

August 4, 2025

Study Completion (Actual)

August 4, 2025

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EKI-2024-0025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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