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

NCT02396303 | Unknown Early Phase 1 DMC

• 1 other identifier: 67365
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Haemorrhage

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Estimated blood loss after cesarean section

  24 hours of delivery

Study Arms (2)

Patient receiving carbetocin

EXPERIMENTAL

Experimental group subjects will receive intravenous Carbetocin during third stage of labour.

Drug: Carbetocin

Patient receiving oxytocin

ACTIVE COMPARATOR

Comparator group subjects will receive intramascular Oxytocin during third stage of labour.

Drug: Carbetocin

Interventions

Carbetocin DRUG

Patient receiving carbetocin; Patient receiving oxytocin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mousumi Paul, MBBS

CONTACT

+8801670789784; chayon.dmc@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Course Student

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

BA (1)