Clinical trial NCT05758012: Carbetocin Compared To Oxytocin During Cesarean Delivery
Official title: Undesired Effects of Carbetocin Compared To Oxytocin Administered As Single Intravenous Dose or Infusion During Cesarean Delivery: A Prospective Randomised Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Delivery
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Kuwait
First posted: 2023-03-07
Enrollment: 260
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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 .

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Normal singleton pregnancy at gestational age of 36 weeks or more.
* Women with common comorbid diagnoses (diabetes, hypothyroidism, hypertension)
* pregnancy after in vitro fertilization

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Myocardial effects
timeFrame: immediately before drug administration
measure: Myocardial effects
timeFrame: 24 hours after drug administration
Secondary outcomes:
measure: Cardiac enzyme
timeFrame: immediately before drug administration
measure: Cardiac enzyme
timeFrame: 24 hours after drug administration
measure: Uterine contraction
timeFrame: One hour post delivery
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Munistery of Health Kuwait
Study officials:
affiliation: Ministry of Health, Kuwait
name: Fatemah Qasem
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.