Carbetocin Versus Oxytocin in Caesarean Section for the Control of Postpartum Haemorrhage

Overview

Post-partum haemorrhage is one of the life threatening emergencies. It accounts for nearly one-quarter of all maternal death worldwide. Atonic uterus contributes about 80% among the causes. Uterotonic drugs are administered following the delivery of baby both in vaginal and caesarean delivery for prevention of PPH. However postpartum haemorrhage cannot always be prevented. But, the incidence and especially its magnitude can be reduced by assessing the risk factors and following the guidelines. The intelligent anticipation, skilled supervision, prompt detection and effective institution of therapy can prevent a normal case from undergoing disastrous consequences. This study will be carried out at Bangabandhu Sheikh Mujib Medical University (BSMMU) within six months after approval. This is a Randomized Control Trial which will compare efficacy of Carbetocin and Oxytocin for the control of PPH. Structured Questionnaire, Data Sheet, hospital indoor documents i.e. Patient chart, operation notes, surgeons visual estimation of blood loss etc will be used as study tool. Ethical clearance will be obtained from Institutional Review Board of BSMMU. Written informed consent will be obtained from the patient or from her legal guardian. Patient confidentiality will be strictly maintained. No name, address or contact details of the patient will be divulged.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2015

Interventions

  • Drug: Carbetocin

Arms, Groups and Cohorts

  • Experimental: Patient receiving carbetocin
    • Experimental group subjects will receive intravenous Carbetocin during third stage of labour.
  • Active Comparator: Patient receiving oxytocin
    • Comparator group subjects will receive intramascular Oxytocin during third stage of labour.

Clinical Trial Outcome Measures

Primary Measures

  • Estimated blood loss after cesarean section
    • Time Frame: 24 hours of delivery

Participating in This Clinical Trial

Inclusion Criteria

  • Patient with risk factors for primary post-partum haemorrhage such as: multiple pregnancy, one or more previous caesarean section, presence of uterine fibroids, previous myomectomy, presence of placenta previa, past history of PPH, fetal macrosomia and fetal malformations associated with polyhydramnios Exclusion Criteria:

  • Presence of hypertension, eclampsia, cardiac, renal or liver diseases, epilepsy, general anaesthesia, as well as women with history of hypersensitivity to Carbetocin according to the Br National Formulary. Patients unwilling to give consent for this study are also excluded

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Mousumi Paul, FCPS Course Student – Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Overall Contact(s)
    • Mousumi Paul, MBBS, +8801670789784, chayon.dmc@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.