Postpartum HemorrhageNCT06776926
Timing of Carbetocin Administration in Postpartum Hemorrhage
A study testing Carbetocin in people with Postpartum Hemorrhage and Carbetocin, run by Mehmet Mete Kırlangıç at 1 site in Turkey (Türkiye).
Trial summary
Postpartum haemorrhage (PPH) is one of the major contributors to maternal mortality and morbidity worldwide. Active management of the third stage of labour has been proven to be effective in the prevention of PPH. Syntometrine is more effective than oxytocin but is associated with more side effects. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Carbetocin
- What is being tested?
- Carbetocin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 28 Feb 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy
- Vaginal delivery at or beyond 38 weeks of gestation
- Primipar
Who cannot join
- Multiparity
- Contraindications to carbetocin use (e.g., pre-existing hypertension, pre-eclampsia,asthma, cardiac, renal, or liver disease)
- High-risk factors for primary postpartum hemorrhage, including grand multiparity,presence of uterine fibroids, or a need for prophylactic oxytocin infusion
- Anemia or
- body mass index (BMI) over 35
- Baby weight over 4000 grams
Show all 9Show fewer
- Comorbidities or chronic diseases
- History of curettage
- Use of propess or oxytocin during labor
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr Lutfi Kirdar City Hospital
Istanbul, Istanbul, 34880
About this study
Official title: When Should Carbetocin be Administered to Prevent Postpartum Hemorrhage After Normal Vaginal Delivery?
Postpartum haemorrhage (PPH) is one of the major contributors to maternal mortality and morbidity worldwide. Active management of the third stage of labour has been proven to be effective in the prevention of PPH. Syntometrine is more effective than oxytocin but is associated with more side effects. Carbetocin, a long-acting oxytocin agonist, appears to be a promising agent for the prevention of PPH. The use of carbetocin, being an important agent in the prevention of PPH, also increases its prevalence. It is planned to investigate the advantages and disadvantages of the timing of its use.
- Conditions
- Postpartum Hemorrhage, Carbetocin
- Being tested
- Carbetocin
- Keywords
- Postpartum hemorrhage, PPH, Carbetocin, Placental retention
- Medical subject headings
- Postpartum Hemorrhage, Placenta, Retained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinBehavioural
Use of carbetocin
| Study group | Role | What they receive |
|---|---|---|
| After placenta is delivered | Experimental | The group that received carbetocin after placenta delivery Receives: Behavioral: Carbetocin |
| Before placenta is delivered | Experimental | The group that received carbetocin before placenta delivery Receives: Behavioral: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbetosin effect
incidence of postpartum hemorrhage >500 ml (percent (%)), additional uterotonics using (yes/no), placenta retention (yes/no), adverse effects (hypotension (yes/no), tachycardia (yes/no), headache(yes/no) oliguria (yes/no)),
Measured: 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start10 Jan 2025
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Mete Kırlangıç
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mehmet Mete Kırlangıç, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776926
- Sponsor's protocol ID
- 2023/514/258/20
- Status last verified
- Sep 2025
- First submitted
- 10 Jan 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Su LL, Chong YS, Samuel M. Carbetocin for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD005457. doi: 10.1002/14651858.CD005457.pub4.
PubMed 22513931Maged AM, El-Goly NA, Turki D, Bassiouny N, El-Demiry N. A systematic review and meta-analysis of randomized trials comparing carbetocin to oxytocin in prevention of postpartum hemorrhage after cesarean delivery in low-risk women. J Obstet Gynaecol Res. 2025 Jan;51(1):e16194. doi: 10.1111/jog.16194.
PubMed 39722234Jin B, Du Y, Zhang F, Zhang K, Wang L, Cui L. Carbetocin for the prevention of postpartum hemorrhage: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2016;29(3):400-7. doi: 10.3109/14767058.2014.1002394. Epub 2015 Sep 4.
PubMed 25579116
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When Should Carbetocin be Administered to Prevent Postpartum Hemorrhage After Normal Vaginal Delivery?
- ClinicalTrials.gov ID
- NCT06776926
- Acronym / sponsor ID
- 2023/514/258/20
- Conditions
- Postpartum Hemorrhage, Carbetocin
- Keywords
- Postpartum hemorrhage, PPH, Carbetocin, Placental retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mehmet Mete KırlangıçOther government
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 15 Jan 2025 (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.
Postpartum haemorrhage (PPH) is one of the major contributors to maternal mortality and morbidity worldwide. Active management of the third stage of labour has been proven to be effective in the prevention of PPH. Syntometrine is more effective than oxytocin but is associated with more side effects. Carbetocin, a long-acting oxytocin agonist, appears to be a promising agent for the prevention of PPH. The use of carbetocin, being an important agent in the prevention of PPH, also increases its prevalence. It is planned to investigate the advantages and disadvantages of the timing of its use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| After placenta is delivered | Experimental | Behavioral: CarbetocinThe group that received carbetocin after placenta delivery |
| Before placenta is delivered | Experimental | Behavioral: CarbetocinThe group that received carbetocin before placenta delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Vaginal delivery at or beyond 38 weeks of gestation
- Primipar
Key exclusion criteria (9 listed)
- Multiparity
- Contraindications to carbetocin use (e.g., pre-existing hypertension, pre-eclampsia,asthma, cardiac, renal, or liver disease)
- High-risk factors for primary postpartum hemorrhage, including grand multiparity,presence of uterine fibroids, or a need for prophylactic oxytocin infusion
- Anemia or
- body mass index (BMI) over 35
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 |
|---|---|---|
| CarbetocinUse of carbetocin | Behavioural | After placenta is delivered, Before placenta is delivered |
Primary outcome
Carbetosin effect
Time frame: 24 hours after delivery
incidence of postpartum hemorrhage >500 ml (percent (%)), additional uterotonics using (yes/no), placenta retention (yes/no), adverse effects (hypotension (yes/no), tachycardia (yes/no), headache(yes/no) oliguria (yes/no)),
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 18 Sep 2025.
- Background: PubMed 22513931Su LL, Chong YS, Samuel M. Carbetocin for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD005457. doi: 10.1002/14651858.CD005457.pub4.
- Background: PubMed 39722234Maged AM, El-Goly NA, Turki D, Bassiouny N, El-Demiry N. A systematic review and meta-analysis of randomized trials comparing carbetocin to oxytocin in prevention of postpartum hemorrhage after cesarean delivery in low-risk women. J Obstet Gynaecol Res. 2025 Jan;51(1):e16194. doi: 10.1111/jog.16194.
- Background: PubMed 25579116Jin B, Du Y, Zhang F, Zhang K, Wang L, Cui L. Carbetocin for the prevention of postpartum hemorrhage: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2016;29(3):400-7. doi: 10.3109/14767058.2014.1002394. Epub 2015 Sep 4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbetocin in people with Postpartum Hemorrhage and Carbetocin, run by Mehmet Mete Kırlangıç at 1 site 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 3 inclusion and 9 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Carbetosin effect (time frame: 24 hours after 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 NCT06776926, which also lists 3 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 18 Sep 2025.