Carbetocin Versus Oxytocin for the Prevention of Postpartum Hemorrhage in Emergency Caesarean Delivery

Summary

Postpartum haemorrhage keeps to be the leading cause of maternal mortality in middle and low-income countries, including Iraq. Much advancement had been made in the field of treatment for postpartum haemorrhage but no much progress had been made in the field of prevention, where one of its main component is the administration of uterotonic, preferably oxytocin, immediately after birth of the baby.

In many low- and middle income countries, the efficacy of oxytocin cannot be assured since access to sustained cold-chain is unavailable. Regarding the other uterotonics; ergometrine degrades when exposed to heat or light. Misoprostol degrades rapidly when exposed to Moisture.

Innovation in the manufacture of carbetocin had meet the stability requirements for hot and humid climates.

This study had been accomplished to evaluate the uterotonic effect of carbetocin compared with oxytocin for the prevention of postpartum haemorrhage in emergency caesarean delivery. Looking if carbetocin is superior to oxytocin in term of reduction in the need for additional uterotonic agents or the occurrence of PPH.

Conditions

• Postpartum Hemorrhage (Primary)

Interventions

DRUG

Carbetocin

Heat stable Carbetocin, a clear colourless solution. Oxytocic activity: approximately 50 IU of oxytocin/vial. One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection, slowly over 1 minute after labor of the baby at once. It was used once and no further doses were given. Drug was kept in cold storage (2 to 8°C).

DRUG

Oxytocin

Oxytocin, a clear colourless solution. One ml of oxytocin (10 IU), was given as a bolus intravenous injection over 1 minute, after labor of the baby at once. Further doses can be given accordingly. Drug was kept in cold storage (2 to 8°C).

Sponsors & Collaborators

• Elweyia Maternity Teaching Hospital

  collaborator OTHER

• Al-Kindy College of Medicine

  lead OTHER

Principal Investigators

• Taghreed K Alhaidari, CABOG · Al Kindy College of Medicine, University of Baghdad

• Shayma S Al-Zubaidy, FICOG, MD · Al- Elweyia Maternity Teaching Hospital

• Alaa A Hussein, FICOG, MD · Al- Elweyia Maternity Teaching Hospital

• Ulfat M Alnakkash, CABOG · Al- Elweyia Maternity Teaching Hospital

• Ahmed S Alnuaimi, PhD · Baghdad College of Medicine/ University of Baghdad

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

43 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-04

Primary Completion

2018-06-10

Completion

2018-08-01

Countries

• Iraq

Study Locations