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FRIMEDBIO-Fri prosj.st. med.,helse,biol

Randomized clinical trial assessing balloon occlusion of the aorta for controlling life-threatening postpartum bleeding in Africa

Alternative title: Bruk av aortaballong for å kontrollere livstruende blødning etter fødsel i Afrika: en randomisert kontrollert studie

Awarded: NOK 12.5 mill.

The leading direct cause of maternal mortality worldwide is heavy bleeding after birth or postpartum haemorrhage (PPH). Every day, over 150 women are dying in the world because of PPH, equivalent to one plane crash per day. Many of these deaths happens in low- and middle-income countries. Many times, even if the mother is giving birth in a hospital, the bleeding may be so profuse, the doctors will witness the woman dying in the operation theatre, simply because there was not enough time to stop the bleeding, or not enough blood available. In such a high-urgency situation with severe PPH, the current bottleneck is to promptly stop the bleeding. In Norway, a new procedure has been added and refined to be part of the standard management to handle heavy bleeding after birth. It is a thin catheter inserted into the artery in the groin up to the aorta. The tip of the catheter has a balloon of a fixed diameter that is inflated by injecting liquid into the catheter. The inflated balloon stops the blood flow in the lower part of the body, and this can safely be done for 30 minutes, enough time to stop the bleeding. It is called Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). Norway pioneers the use of the aorta balloon, an approach suitable for emergency PPH situations. In this project, we are proposing a trial to assess if a device can prevent birthing mothers in Africa from bleeding to death after birth. Our hypothesis is that the use of REBOA in hospitals outside of Norway will save women’s lives due to severe PPH, specifically in low- and middle-income countries, where most of the deaths occur, which could subsequently contribute to the decrease of global maternal mortality rate. The randomised controlled trial will include women with severe PPH and will be conducted in Uganda, in collaboration with Makerere University, the Universities of Padua and Liverpool and the University Hospitals of Stavanger and Trondheim.

The leading direct cause of maternal mortality worldwide is heavy bleeding after birth or postpartum haemorrhage (PPH). Every day, over 150 women are dying in the world because of PPH, equivalent to one plane crash per day. Many of these deaths happens in low- and middle-income countries. Many times, even if the mother is giving birth in a hospital, the bleeding may be so profuse, the doctors will witness the woman dying in the operation theatre, simply because there was not enough time to stop the bleeding, or not enough blood available. In such a high-urgency situation with severe PPH, the current bottleneck is to promptly stop the bleeding. In Norway, a new procedure has been added and refined to be part of the standard management to handle heavy bleeding after birth. It is a thin catheter inserted into the artery in the groin up to the aorta. The tip of the catheter has a balloon of a fixed diameter that is inflated by injecting liquid into the catheter. The inflated balloon stops the blood flow in the lower part of the body, and this can safely be done for 30 minutes, enough time to stop the bleeding. It is called Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). Norway pioneers the use of the aorta balloon, an approach suitable for emergency PPH situations. In this project, we are proposing a trial to assess if a device can prevent birthing mothers in Africa from bleeding to death after birth. Our hypothesis is that the use of REBOA in hospitals outside of Norway will save women’s lives due to severe PPH, specifically in low- and middle-income countries, where most of the deaths occur, which could subsequently contribute to the decrease of global maternal mortality rate. The randomised controlled trial will include women with severe PPH and will be conducted in Uganda, in collaboration with Makerere University, the Universities of Padua and Liverpool and the University Hospitals of Stavanger and Trondheim.

Funding scheme:

FRIMEDBIO-Fri prosj.st. med.,helse,biol

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