Postpartum Hemorrhage \(PPH\)EMERGE-CSNCT07380529
Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients
A study testing Carbetocin and Oxytocin in people with Postpartum Hemorrhage \(PPH\), run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage \(PPH\)
- What is being tested?
- Carbetocin and Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 4 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Etlik City Hospital
Ankara, Yenimahalle, 06010
Etlik City Hospital
Ankara, Yenimahalle, 06170
About this study
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.
Read the 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 \(PPH\)
- Being tested
- Carbetocin, Oxytocin
- Keywords
- carbetocin, postpartum hemorrhage, oxytocin, emergency caesarean delivery
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Carbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage
OxytocinDrug
Oxytocin administered per institutional standard regimen immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Standard oxytocin regimen after delivery (uterotonic prophylaxis at emergency cesarean) Receives: Drug: Oxytocin |
| carbetocin | Experimental | Carbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative change in hemoglobin at 24 hours
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.
Measured: Baseline (preoperative) and within 24 hours after emergency cesarean delivery
Secondary outcomes (2)
Need for additional uterotonic agents
Proportion of participants requiring any additional uterotonic agent(s) within 24 hours after cesarean delivery (after administration of the assigned study drug).
Measured: Within 24 hours after cesarean delivery
Postoperative change in hematocrit at 24 hours
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.
Measured: Baseline (preoperative) and within 24 hours after emergency cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Oct 2024
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum Hemorrhage \(PPH\)Studies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tahir Eryılmaz, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- TAHİR ERYILMAZ, M.D. Dr., Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380529
- Sponsor's protocol ID
- AEŞH-EKI-2024-0025
- Acronym
- EMERGE-CS
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Razali N, Md Latar IL, Chan YK, Omar SZ, Tan PC. Carbetocin compared to oxytocin in emergency cesarean section: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2016 Mar;198:35-39. doi: 10.1016/j.ejogrb.2015.12.017. Epub 2015 Dec 30.
PubMed 26773246Eryilmaz T, Gayretli TK, Sefik SO, Kucukkayici AS, Keskin HL. Carbetocin and oxytocin use in emergency cesarean delivery: a prospective observational study of 24-hour bleeding outcomes. BMC Pregnancy Childbirth. 2026 Jul 11. doi: 10.1186/s12884-026-09626-9. Online ahead of print.
PubMed 42436390
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients
- ClinicalTrials.gov ID
- NCT07380529
- Acronym / sponsor ID
- EMERGE-CS / AEŞH-EKI-2024-0025
- Conditions
- Postpartum Hemorrhage \(PPH\)
- Keywords
- carbetocin, postpartum hemorrhage, oxytocin, emergency caesarean delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: OxytocinStandard oxytocin regimen after delivery (uterotonic prophylaxis at emergency cesarean) |
| carbetocin | Experimental | Drug: CarbetocinCarbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Term pregnancy (>37 weeks gestation)
- Singleton pregnancy
- Vertex presentation
- not having had a cesarean section before
- emergency cesarean delivery (category 1)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbetocinCarbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage | Drug | carbetocin |
| OxytocinOxytocin administered per institutional standard regimen immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage | Drug | Oxytocin |
Primary outcome
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.
2 secondary outcomes
Need for additional uterotonic agents
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Results publication: PubMed 26773246Razali N, Md Latar IL, Chan YK, Omar SZ, Tan PC. Carbetocin compared to oxytocin in emergency cesarean section: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2016 Mar;198:35-39. doi: 10.1016/j.ejogrb.2015.12.017. Epub 2015 Dec 30.
- Derived from this study: PubMed 42436390Eryilmaz T, Gayretli TK, Sefik SO, Kucukkayici AS, Keskin HL. Carbetocin and oxytocin use in emergency cesarean delivery: a prospective observational study of 24-hour bleeding outcomes. BMC Pregnancy Childbirth. 2026 Jul 11. doi: 10.1186/s12884-026-09626-9. Online ahead of print.
- Utilization of carbetocin for prevention of postpartum hemorrhage after cesarean section: a randomized clinical trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TAHİR ERYILMAZ, M.D. Dr. principal investigator
Ankara Etlik City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbetocin and Oxytocin in people with Postpartum Hemorrhage \(PPH\), run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative change in hemoglobin at 24 hours (time frame: Baseline (preoperative) and within 24 hours after emergency cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07380529, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.