Randomized clinical trial assessing balloon occlusion of the aorta for controlling life-threatening postpartum bleeding in Africa (REBOA)
The leading direct cause of maternal mortality worldwide is heavy bleeding after birth or postpartum haemorrhage. In this randomized trial we want to assess the efficacy of resuscitative endovascular balloon occlusion of the aorta (REBOA) for postpartum haemorrhage (bleeding after birth) in a low-income country with high maternal mortality. In women with severe postpartum haemorrhage, can the application of REBOA before necessary actions to stop the bleeding, compared to standard of care, reduce mortality?
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The leading direct cause of maternal mortality worldwide is heavy bleeding after birth or postpartum haemorrhage. 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, 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 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 REBOA team from left: Uganda PI Prof Josaphat Byamugisha, Dr Clare Lubulwa, the research assistants (purple scrubs), project manager Hadija Nalubwama. Sitting: Data manager Damien Wasswa. Behind: Prof Thorkild Tylleskär, University of Bergen