A randomized controlled, open labelled clinical trial comparing the efficacy of carbetocin versus oxytocin in prevention of post partum hemorrhage.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Primary outcome is to compare the efficacy of carbetocin and oxytocin in preventing intraoperative blood loss
Study Overview
Brief Summary
To summarise this study, postpartum haemorrhage is a major concern nowadays in high-risk patients for PPH undergoing cesarean section. although oxytocin is a gold standard drug in preventing PPH and carbetocin a novel drug came to the market with flying colours is used to prevent PPH, comparing these two drugs by administering to high risk PPH patients who are all undergoing c section.
in this study we can measure the hemodynamic variability in both intra operative as well post operative period.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Women aged 18 yrs to 50 years.
- •2.Multiple pregnancy.
- •3.Scheduled for Elective cesarean section under spinal anaesthesia.
- •4.Prolonged third stage labour.
- •5.Fetal macrosomia.
- •6.History of post partum hemorrhage.
- •7.Grand multiparity.
- •8.Placenta previa.
- •9.Placental abruption.
- •10.Pregnancy induced hypertension.
- •11.ASA I and II.
Exclusion Criteria
- •1.Patient refusal.
- •2.History of thromboembolic disorder.
- •3.Patients suffering from other chronic illness like COPD or any active LRTI.
- •4.Preexisting neuropathy.
- •5.Eclampsia and HELLP syndrome.
- •6.Contraindication to Spinal anesthesia.
- •7.Any known allergy to local anaesthetia or general anaesthesia.
Outcomes
Primary Outcomes
Primary outcome is to compare the efficacy of carbetocin and oxytocin in preventing intraoperative blood loss
Time Frame: 1.(T0) at carbetocin /oxytocin injection. | 2.(T1) end of operation procedure. | 3. (T3) 2 hr post operative period. | 4. (T4) 12 hr post operative period.
Secondary Outcomes
- haemodynamic variable(after administering two drugs take taken in T1 min)
Investigators
DR V Bhuvaneshwaran
Department of anaesthesiology