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Effect of Carbetocin in pregnant women undergoing elective caesarean section

Evaluation of haemodynamic effects of Carbetocin in parturients undergoing elective caesarean section- A randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046376
Enrollment
60
Registered
2022-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: CARBETOCIN: 100 mcg intravenous single bolus dose Control Intervention1: OXYTOCIN: 5 IU intravenous bolus dose followed by 20 IU maintenance dose added to 1L 0.9% NS and to be infused a

Sponsors

SIR GANGA RAM HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pregnancy � 34 weeks gestation 2.Age >18 years 3.Singleton pregnancy

Exclusion criteria

Exclusion criteria: 1.Refusal to consent 2.Pre-existing hypertension, gestational hypertension, pre-eclampsia or eclampsia 3.Cardiovascular diseases (arrhythmia, ischaemic or valvular heart disease, cardiomyopathy) 4.Liver disease 5.Renal impairment (S. Creatinine > 1.2mg/dL) 6.Uncontrolled thyroid disorder 7.Uncontrolled diabetes 8.History of hypersensitivity to carbetocin or oxytocin 9.General anaesthesia 10.Multiple gestation 11.Previous history of placenta previa, placental abruption Coagulopathy

Design outcomes

Primary

MeasureTime frame
To compare the change in maternal heart rate following administration of carbetocin or oxytocin in parturients undergoing elective caesarean section under subarachnoid blockTimepoint: 1 min, 2 min, 3 min, 4 min, 5 min after study drug administration, at the time of uterine repair, skin closure and 30 min, 60 min, 120 min after completion of surgery—

Secondary

MeasureTime frame
Need for rescue uterotonic agentsTimepoint: 2 min, 4 min after study drug administration, at uterine repair, skin closure and 30 min, 60 min, 120 min after completion of surgery.;To compare adverse effects such as nausea, vomiting, facial flushing or headache after administration of carbetocin or oxytocin in parturients undergoing elective caesarean section under subarachnoid blockTimepoint: 1 min, 2 min, 3 min, 4 min, 5 min after study drug administration, at the time of uterine repair, skin closure and 30 min, 60 min, 120 min after completion of surgery;To compare changes in the mean arterial pressure after administration of carbetocin or oxytocin in parturients undergoing elective caesarean section under subarachnoid blockTimepoint: 1 min, 2 min, 3 min, 4 min, 5 min after study drug administration, at the time of uterine repair, skin closure and 30 min, 60 min, 120 min after completion of surgery—

Countries

India

Contacts

Public ContactDR PALLABI CHATTERJEE

Institute of Anaesthesiology Pain and Perioperative Medicine, Sir Ganga Ram Hospital

anjeleenasgrh@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026