Current partner codePEPTIDESDE
NCT07380529·Not applicable·INTERVENTIONAL

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

Not applicable

Enrollment

300

Locations

2

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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

From registration to results.

  1. First posted

    Feb 2, 2026

  2. Study start

    Oct 1, 2024

  3. Primary completion

    Aug 4, 2025

  4. Study completion

    Aug 4, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Feb 13, 2026

Outcomes

What the study measures.

Primary outcomes

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

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).

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.

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
Yes

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 locations

2 registered sites.

Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.

Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

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