Cesarean DeliveryNCT05758012
Carbetocin Compared To Oxytocin During Cesarean Delivery
An observational study of Cesarean Delivery, run by Assiut University at 1 site in Kuwait.
Trial summary
As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the… Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- oxytocin and Carbetocin
- Type of treatment
- Injection or infusion
- How many people
- 260 participants
- Where
- 1 siteKuwait
- Study dates
- 1 May 2023to 1 Dec 2024
- 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 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women will be recruited from the pregnant women attending antenatal clinics in Sabah Maternity Hospital and planned for Delivery either vaginal or Cesarean section .
Who may be able to join
- Normal singleton pregnancy at gestational age of 36 weeks or more.
- Women with common comorbid diagnoses (diabetes, hypothyroidism, hypertension)
- pregnancy after in vitro fertilization
Who cannot join
- placenta praevia or invasive placenta.
- pre-eclampsia.
- Bleeding disorder, such as von Willebrand disease type I.
- Current treatment with low-molecular-weight heparin or other anticoagulation medication (not including aspirin).
- Any known intolerance to either of the study drugs.
- Prolonged QT-time.
- Other serious cardiac disease.
- Liver or kidney failure.
Trial locations and contacts
1 site in 1 country.
Kuwait1 site
Munistery of Health Kuwait
Kuwait City
Fatemah Qasem, +96599511550, fatemahq82@gmail.com
Mohamed Farghaly, +96551199166, mohamedfarghali@hotmail.com
About this study
Official title: Undesired Effects of Carbetocin Compared To Oxytocin Administered As Single Intravenous Dose or Infusion During Cesarean Delivery: A Prospective Randomised Controlled Study
As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.
Read the detailed description
Although the difference between carbetocin and oxytocin in terms of hemodynamic changes, postpartum blood loss and incidence of side effects is not statistically significant. serious cardiovascular adverse events, including ST segment depression, hypotension and tachycardia have been reported after IV oxytocin. Oxytocin dose reduction and/or increased infusion duration may reduce risk of some cardiac-related adverse effects and increase patient safety. As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.
- Conditions
- Cesarean Delivery
- Being tested
- oxytocin, Carbetocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
Also called Syntocinon
Participants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders
CarbetocinDrug
Also called Pabal
Participants will be randomized to receive Cabetocin after delivery of the baby's head and shoulders
| Study group | Role | What they receive |
|---|---|---|
| oxytocin group | Oxytocin 5 IU will be administered by a trained anaesthetist as a one-minute IV injection. Receives: Drug: oxytocin | |
| Carbetocin group | Carbetocin 100 μg will be administered by a trained anaesthetist as a one-minute IV injection. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial effects
Electrocardiograph (QT interval)
Measured: immediately before drug administration
Myocardial effects
Electrocardiograph (QT interval)
Measured: 24 hours after drug administration
Secondary outcomes (3)
Cardiac enzyme
Troponin
Measured: immediately before drug administration
Cardiac enzyme
Troponin
Measured: 24 hours after drug administration
Uterine contraction
Palpate the fundus throughout a contraction to determine intensity
Measured: One hour post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Kuwait
- Responsible party
- Principal investigator, Abdelrady S Ibrahim, MD, Assiut University
- Investigators
- Fatemah Qasem, Principal investigator, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758012
- Sponsor's protocol ID
- IRB0000871251
- Status last verified
- Mar 2023
- First submitted
- 4 Nov 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the results of the study will be shared with other researchers.
Publications
Masuzawa Y, Kataoka Y, Fujii K, Inoue S. Prophylactic management of postpartum haemorrhage in the third stage of labour: an overview of systematic reviews. Syst Rev. 2018 Oct 11;7(1):156. doi: 10.1186/s13643-018-0817-3.
PubMed 30305154
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undesired Effects of Carbetocin Compared To Oxytocin Administered As Single Intravenous Dose or Infusion During Cesarean Delivery: A Prospective Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05758012
- Acronym / sponsor ID
- IRB0000871251
- Conditions
- Cesarean Delivery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Kuwait
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 7 Mar 2023 (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.
As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.
Detailed description
Although the difference between carbetocin and oxytocin in terms of hemodynamic changes, postpartum blood loss and incidence of side effects is not statistically significant. serious cardiovascular adverse events, including ST segment depression, hypotension and tachycardia have been reported after IV oxytocin. Oxytocin dose reduction and/or increased infusion duration may reduce risk of some cardiac-related adverse effects and increase patient safety. As both oxytocin and carbetocin are used daily in obstetric units all over the world, the investigators find it compelling to investigate whether the hemodynamic and myocardial effects of oxytocin and carbetocin are comparable in healthy women during delivery and determine any potential harmful effects following the use of oxytocin or Carbetocin as uterotonic. Other endpoints relating to uterus tone, blood loss, blood pressure, heart rate, post-operative pain and side effects will also be assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin group | – | Drug: oxytocinOxytocin 5 IU will be administered by a trained anaesthetist as a one-minute IV injection. |
| Carbetocin group | – | Drug: CarbetocinCarbetocin 100 μg will be administered by a trained anaesthetist as a one-minute IV injection. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women will be recruited from the pregnant women attending antenatal clinics in Sabah Maternity Hospital and planned for Delivery either vaginal or Cesarean section .
Key inclusion criteria (3 listed)
- Normal singleton pregnancy at gestational age of 36 weeks or more.
- Women with common comorbid diagnoses (diabetes, hypothyroidism, hypertension)
- pregnancy after in vitro fertilization
Key exclusion criteria (8 listed)
- placenta praevia or invasive placenta.
- pre-eclampsia.
- Bleeding disorder, such as von Willebrand disease type I.
- Current treatment with low-molecular-weight heparin or other anticoagulation medication (not including aspirin).
- Any known intolerance to either of the study drugs.
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: SyntocinonParticipants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders | Drug | oxytocin group |
| CarbetocinAlso: PabalParticipants will be randomized to receive Cabetocin after delivery of the baby's head and shoulders | Drug | Carbetocin group |
Primary outcome
Myocardial effects
Time frame: immediately before drug administration
Electrocardiograph (QT interval)
Myocardial effects
Time frame: 24 hours after drug administration
Electrocardiograph (QT interval)
3 secondary outcomes
Cardiac enzyme
Time frame: immediately before drug administration
Cardiac enzyme
Time frame: 24 hours after drug administration
Uterine contraction
Time frame: One hour post delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 30305154Masuzawa Y, Kataoka Y, Fujii K, Inoue S. Prophylactic management of postpartum haemorrhage in the third stage of labour: an overview of systematic reviews. Syst Rev. 2018 Oct 11;7(1):156. doi: 10.1186/s13643-018-0817-3.
- Individual participant dataSharing planned: Undecided. the results of the study will be shared with other researchers.
Related trials for Cesarean Delivery
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
Fatemah Qasem principal investigator
Ministry of Health, Kuwait
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 Cesarean Delivery, run by Assiut University at 1 site in Kuwait.
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 8 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. 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 Kuwait. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatemah Qasem (+98599511550, fatemahq82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial effects (time frame: immediately before drug administration). The study lists 2 primary outcomes in all. 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 NCT05758012, which also lists 1 linked publication.
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 7 Mar 2023.