For the first time in a developing country, the study evaluated the combination of two tools (a biomarker test and the World Health Organization’s fullPIERS protocol, which were combined and transformed into an algorithm) to identify risks of complications associated with preeclampsia. The objective was to provide doctors with reliable indicators to help them decide whether to prolong pregnancy, avoiding unnecessary cesarean sections and reducing premature births associated with the disease. The researchers also created a biobank with blood and urine samples from 4,000 pregnant women, collected during three stages of pregnancy: at the beginning of the pregnancy, between 28 and 32 weeks and at delivery.
How was the experiment
The study tested whether the protocol effectively prolonged pregnancy and reduced premature births in eight hospitals in Rio de Janeiro, São Paulo and Porto Alegre. The objective was to recruit 1200 women in these centers, which were randomly selected. As they were chosen, they offered the protocol to all pregnant women with confirmed or suspected pre-eclampsia admitted to maternity wards with less than 37 weeks of gestation. The team created a biobank with blood and urine samples from 4000 women during prenatal care. They were collected at three moments during pregnancy: at the beginning, between 28 and 32 weeks and at the delivery time. The team also included these repository samples of pregnant women with pre-eclampsia who joined the the clinical test.
The team is still tabulating the data for the following outcomes:
- reduction of prematurity, which leads to numerous consequences for the health of the newborn, with long-term impacts on their quality of life;
- reduction of maternal mortality rates related to pre-eclampsia due to the promotion of not only preventive actions but also better care for pregnant women affected by the disease;
- reduction in birth and neomortality rates [VW1] as a result of reducing the prevalence of pre-eclampsia and improving care related to its complications.
Why is it innovative
It is the first time that a combination of the test showing the relationship of sFlT-1 (soluble tyrosine kinase) and PlGF (placental growth factor) and the full PIERS protocol (Pre-eclampsia integrated estimate of risk) has been implemented and evaluated in a developing country. The objective is to provide health professionals with a way to make safe decisions based on best practices in the face of pre-eclampsia.
Problem that solves
The tool helps doctors make decision on the best course of action in the face of pre-eclampsia: performing an emergency cesarean section to guarantee the life of the mother and baby or prolonging the pregnancy for a longer period of time to avoid premature birth.
Implications for the brazilian health system
If the protocol proves to be effective in assisting physicians in making decisions and reducing prematurity, it could be implemented more broadly in health services. The group is conducting cost-effectiveness studies, but it is expected that the decrease in premature births will lead to a lower admission rate of newborns in neonatal ICUs, with a resulting reduction in costs.
Implications for global health
Pre-eclampsia is among the top three causes of maternal mortality in the world and is especially devastating on the African continent, as the risk of hypertension is greater among black women. If the study demonstrates that the protocol is effective, it will be necessary to cheapen and simplify the test of biomarkers – perhaps using one of the two indicators – to make it viable at scale.
The team intends to assess the economic impacts of actions to prevent pre-eclampsia and reduce prematurity by delaying the termination of pregnancy. They are also completing a satisfaction survey with professionals, to evaluate the use of the new algorithm, and of pregnant women who received care.
- PREPARE: protocol for a stepped wedge trial to evaluate whether a risk stratification model can reduce preterm deliveries among women with suspected or confirmed preterm pre-eclampsia - 10/2019
- Creating biobanks in low and middle-income countries to improve knowledge – The PREPARE initiative - 07/2018