Cesarean Delivery
Conditions
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.
Interventions
DRUGoxytocin
Participants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders
DRUGCarbetocin
Participants will be randomized to receive Cabetocin after delivery of the baby's head and shoulders
Sponsors
Ministry of Health, Kuwait
Assiut University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial effects | immediately before drug administration | Electrocardiograph (QT interval) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac enzyme | immediately before drug administration | Troponin |
| Uterine contraction | One hour post delivery | Palpate the fundus throughout a contraction to determine intensity |
Countries
Kuwait
Contacts
Primary ContactFatemah Qasem
Backup ContactMohamed Farghaly
Outcome results
None listed