PREG1NCT06692621
Effects of Carbetocin and Oxytocin Used in Cesarean Sections on Postoperative Pain
An observational study of PREG1, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to compare postoperative analgesic consumption in patients who received peroperative carbetocin or oxytocin. The main question it aims to answer is: . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PREG1
- What is being tested?
- Oxytocin and Carbetocin
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2024to 10 Jan 2025
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between the ages of 18-45
Who may be able to join
- Pregnant women in the American Society of Anesthesiologists (ASA) II class,
- who have had a previous uncomplicated cesarean delivery,
- who are 18-45 years old and are planned to undergo elective cesarean section with spinal anesthesia technique
Who cannot join
- Patients who cannot use the patient controlled analgesia (PCA) device postoperatively,
- have limited intellectual function
- have contraindications for spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this observational study is to compare postoperative analgesic consumption in patients who received peroperative carbetocin or oxytocin. The main question it aims to answer is:
. Does peroperative carbetocin use reduce postoperative analgesic consumption compared to oxytocin?
Patients who receive routine uterotonic agents in caesarean section surgeries will be divided into two groups and their postoperative 24-hour analgesic consumption will be compared.
Read the detailed description
Postpartum hemorrhage (PPH) is one of the most important causes of perioperative maternal deaths. Oxytocin and carbetocin are the most important uterotonic agents used for PPH. Oxytocin has a half-life of 4-10 minutes (min) and can provide continuous uterotonic properties through infusion. Carbetocin, which has been used increasingly in recent years, is a synthetic analogue of oxytocin and has a strong uterotonic effect on oxytocin receptors. Oxytocin, which is used in PPH prophylaxis and management in cesarean delivery, has some maternal side effects depending on the rate of administration. These are cardiovascular effects, nausea, vomiting, headache and allergic reactions. Since it is structurally similar to vasopressin, water retention in the body and hyponatremia, convulsions and coma can be seen, although rarely. The most common cardiac effects after oxytocin administration are dose-dependent hypotension and tachycardia. Smooth muscle relaxation caused by stimulation of calcium-dependent nitrite oxide is held responsible for hypotension.[3] Carbetocin, a long-acting oxytocin analog, has similar side effects and further research is needed on its effectiveness.
There are potential studies supporting that the oxytocinergic system affects pain perception. Oxytocin released into the central nervous system plays an important role in the transmission and modulation of pain signals. Glutamatergic activation of oxytocin in the dorsal root ganglia results in GABAergic inhibition of Aδ and C fibers that play a role in nociception. Carbetocin is also thought to have similar effects in analgesia. Although there are studies showing that carbetocin reduces postoperative analgesic use compared to oxytocin , there is no clear consensus in the literature on this subject. The studies conducted by De Bonis et al. and Gawecka et al. were guiding in designing this study. While De Bonis et al. found that carbetocin reduces analgesic consumption, Gawecka et al. could not show a significant difference between the two agents.
In this study, the investigators aim to contribute to the literature by comparing the analgesic activities of oxytocin and carbetocin to observe the differences in hemodynamic and other side effects of these two agents.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Deva İlaç Sanayi, Turkey
Medicines were administered in appropriate doses
CarbetocinDrug
Also called Ferring GmbH, Germany
Medicines were administered in appropriate doses
| Study group | Role | What they receive |
|---|---|---|
| O:oxytocin | In the oxytocin group, oxytocin ('Synpitan forte 5 IU/ml im/iv ampoule, Deva İlaç Sanayi, Turkey)' was administered 20 IU intravenously (5 IU intravenous bolus followed by 15 IU/hour infusion) in accordance with the recommendations of the Ministry of Health of the Republic of Turkey. Receives: Drug: Oxytocin | |
| C:carbetocin | In the carbetocin group, carbetocin 'Pabal 100 microgram/ml iv solution for injection ampoule, Ferring GmbH, Germany) was diluted with 20 ml of 0.9% NaCl solution and administered over 30-60 seconds. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 24-hour analgesic consumption (Total tramadol mg / 24 hours )
analgesic consumption
Measured: 04/10/2024-04/01/2025
Secondary outcomes (4)
amount of intraoperative bleeding (Preoperative / postoperative hemoglobin g/dl )
intraoperative bleeding
Measured: 04/10/2024-04/01/2025
Postoperative 24-hour Heart rate variables (/minute)
Postoperative 24-hour hemodynamic variables
Measured: 04/10/2024-04/01/2025
Postoperative 24-hour arterial blood pressure variables (mmHg)
Postoperative 24-hour hemodynamic variables
Measured: 04/10/2024-04/01/2025
Postoperative 24-hour oxygen saturation variables (%)
Postoperative 24-hour hemodynamic variables
Measured: 04/10/2024-04/01/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start4 Oct 2024
- Primary completion7 Jan 2025
- Study completion10 Jan 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 PREG1Studies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Havva Esra Türkyılmaz Uyar, Study director, esrauyarturkyilmaz@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692621
- Sponsor's protocol ID
- E2-234595
- Status last verified
- Mar 2025
- First submitted
- 21 Oct 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Bonis M, Torricelli M, Leoni L, Berti P, Ciani V, Puzzutiello R, Severi FM, Petraglia F. Carbetocin versus oxytocin after caesarean section: similar efficacy but reduced pain perception in women with high risk of postpartum haemorrhage. J Matern Fetal Neonatal Med. 2012 Jun;25(6):732-5. doi: 10.3109/14767058.2011.587920. Epub 2011 Jul 15.
PubMed 21761999Gawecka E, Rosseland LA. A secondary analysis of a randomized placebo-controlled trial comparing the analgesic effects of oxytocin with carbetocin: postcesarean delivery morphine equivalents. Anesth Analg. 2014 Oct;119(4):1004. doi: 10.1213/ANE.0000000000000372. No abstract available.
PubMed 25232698
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carbetocin and Oxytocin Used in Cesarean Sections on Postoperative Pain
- ClinicalTrials.gov ID
- NCT06692621
- Acronym / sponsor ID
- E2-234595
- Conditions
- PREG1
- Keywords
- carbetocin, oxytocin, cesarean analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 18 Nov 2024 (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.
The aim of this observational study is to compare postoperative analgesic consumption in patients who received peroperative carbetocin or oxytocin. The main question it aims to answer is:
. Does peroperative carbetocin use reduce postoperative analgesic consumption compared to oxytocin?
Patients who receive routine uterotonic agents in caesarean section surgeries will be divided into two groups and their postoperative 24-hour analgesic consumption will be compared.
Detailed description
Postpartum hemorrhage (PPH) is one of the most important causes of perioperative maternal deaths. Oxytocin and carbetocin are the most important uterotonic agents used for PPH. Oxytocin has a half-life of 4-10 minutes (min) and can provide continuous uterotonic properties through infusion. Carbetocin, which has been used increasingly in recent years, is a synthetic analogue of oxytocin and has a strong uterotonic effect on oxytocin receptors. Oxytocin, which is used in PPH prophylaxis and management in cesarean delivery, has some maternal side effects depending on the rate of administration. These are cardiovascular effects, nausea, vomiting, headache and allergic reactions. Since it is structurally similar to vasopressin, water retention in the body and hyponatremia, convulsions and coma can be seen, although rarely. The most common cardiac effects after oxytocin administration are dose-dependent hypotension and tachycardia. Smooth muscle relaxation caused by stimulation of calcium-dependent nitrite oxide is held responsible for hypotension.[3] Carbetocin, a long-acting oxytocin analog, has similar side effects and further research is needed on its effectiveness.
There are potential studies supporting that the oxytocinergic system affects pain perception. Oxytocin released into the central nervous system plays an important role in the transmission and modulation of pain signals. Glutamatergic activation of oxytocin in the dorsal root ganglia results in GABAergic inhibition of Aδ and C fibers that play a role in nociception. Carbetocin is also thought to have similar effects in analgesia. Although there are studies showing that carbetocin reduces postoperative analgesic use compared to oxytocin , there is no clear consensus in the literature on this subject. The studies conducted by De Bonis et al. and Gawecka et al. were guiding in designing this study. While De Bonis et al. found that carbetocin reduces analgesic consumption, Gawecka et al. could not show a significant difference between the two agents.
In this study, the investigators aim to contribute to the literature by comparing the analgesic activities of oxytocin and carbetocin to observe the differences in hemodynamic and other side effects of these two agents.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O:oxytocin | – | Drug: OxytocinIn the oxytocin group, oxytocin ('Synpitan forte 5 IU/ml im/iv ampoule, Deva İlaç Sanayi, Turkey)' was administered 20 IU intravenously (5 IU intravenous bolus followed by 15 IU/hour infusion) in accordance with the recommendations of the Ministry of Health of the Republic of Turkey. |
| C:carbetocin | – | Drug: CarbetocinIn the carbetocin group, carbetocin 'Pabal 100 microgram/ml iv solution for injection ampoule, Ferring GmbH, Germany) was diluted with 20 ml of 0.9% NaCl solution and administered over 30-60 seconds. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between the ages of 18-45
Key inclusion criteria (3 listed)
- Pregnant women in the American Society of Anesthesiologists (ASA) II class,
- who have had a previous uncomplicated cesarean delivery,
- who are 18-45 years old and are planned to undergo elective cesarean section with spinal anesthesia technique
Key exclusion criteria (3 listed)
- Patients who cannot use the patient controlled analgesia (PCA) device postoperatively,
- have limited intellectual function
- have contraindications for spinal anesthesia
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 |
|---|---|---|
| OxytocinAlso: Deva İlaç Sanayi, TurkeyMedicines were administered in appropriate doses | Drug | O:oxytocin |
| CarbetocinAlso: Ferring GmbH, GermanyMedicines were administered in appropriate doses | Drug | C:carbetocin |
Primary outcome
Postoperative 24-hour analgesic consumption (Total tramadol mg / 24 hours )
Time frame: 04/10/2024-04/01/2025
analgesic consumption
4 secondary outcomes
amount of intraoperative bleeding (Preoperative / postoperative hemoglobin g/dl )
Time frame: 04/10/2024-04/01/2025
Postoperative 24-hour Heart rate variables (/minute)
Time frame: 04/10/2024-04/01/2025
Postoperative 24-hour arterial blood pressure variables (mmHg)
Time frame: 04/10/2024-04/01/2025
Postoperative 24-hour oxygen saturation variables (%)
Time frame: 04/10/2024-04/01/2025
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 24 Mar 2025.
- Background: PubMed 21761999De Bonis M, Torricelli M, Leoni L, Berti P, Ciani V, Puzzutiello R, Severi FM, Petraglia F. Carbetocin versus oxytocin after caesarean section: similar efficacy but reduced pain perception in women with high risk of postpartum haemorrhage. J Matern Fetal Neonatal Med. 2012 Jun;25(6):732-5. doi: 10.3109/14767058.2011.587920. Epub 2011 Jul 15.
- Background: PubMed 25232698Gawecka E, Rosseland LA. A secondary analysis of a randomized placebo-controlled trial comparing the analgesic effects of oxytocin with carbetocin: postcesarean delivery morphine equivalents. Anesth Analg. 2014 Oct;119(4):1004. doi: 10.1213/ANE.0000000000000372. No abstract available.
- main sourceLink provided by the sponsor.
- main sourceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Havva Esra Türkyılmaz Uyar study director
esrauyarturkyilmaz@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PREG1, run by Ankara City Hospital Bilkent 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 3 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 24 Mar 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?
Postoperative 24-hour analgesic consumption (Total tramadol mg / 24 hours ) (time frame: 04/10/2024-04/01/2025). 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 NCT06692621, 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 24 Mar 2025.