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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02396303
Enrollment
100
Registered
2015-03-24
Start date
2015-06-30
Completion date
2015-11-30
Last updated
2015-03-24

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

Conditions

Postpartum Haemorrhage

Keywords

General: To compare Carbetocin and Oxytocin for the control of PPH.

Brief summary

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.

Interventions

DRUGCarbetocin

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Estimated blood loss after cesarean section24 hours of delivery

Countries

Bangladesh

Contacts

Primary ContactMousumi Paul, MBBS
chayon.dmc@gmail.com+8801670789784

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026