An observational study in Cesarean Delivery, sponsored by Assiut University. Not yet recruiting at 1 site in Kuwait. Open to female participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by Assiut University · Observational
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.
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.
Women will be recruited from the pregnant women attending antenatal clinics in Sabah Maternity Hospital and planned for Delivery either vaginal or Cesarean section .
Exclusion Criteria:
Oxytocin 5 IU will be administered by a trained anaesthetist as a one-minute IV injection.
Drug: oxytocin
Carbetocin 100 μg will be administered by a trained anaesthetist as a one-minute IV injection.
Drug: Carbetocin
Participants will be randomized to receive Oxytocin after delivery of the baby's head and shoulders
Also known as: Syntocinon
Participants will be randomized to receive Cabetocin after delivery of the baby's head and shoulders
Also known as: Pabal
Myocardial effects
Electrocardiograph (QT interval)
Time frame: immediately before drug administration
Myocardial effects
Electrocardiograph (QT interval)
Time frame: 24 hours after drug administration
Cardiac enzyme
Troponin
Time frame: immediately before drug administration
Cardiac enzyme
Troponin
Time frame: 24 hours after drug administration
Uterine contraction
Palpate the fundus throughout a contraction to determine intensity
Time frame: One hour post delivery
Plan to share: Undecided — the results of the study will be shared with other researchers.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Assiut University