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.
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women will be recruited from the pregnant women attending antenatal clinics in Sabah Maternity Hospital and planned for Delivery either vaginal or Cesarean section .
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Start is estimated for May 2023; primary completion for Nov 2024, 18 months later.
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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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