The PRECISE (PREgnancy Care Integrating translational Science, Everywhere) Network’s first protocol: deep phenotyping in three sub-Saharan African countries

Abstract

Background The PRECISE (PREgnancy Care Integrating translational Science, Everywhere) Network is a new and broadly-based group of research scientists and health advocates based in the UK, Africa and North America. Methods This paper describes the protocol that underpins the clinical research activity of the Network, so that the investigators, and broader global health community, can have access to ‘deep phenotyping’ (social determinants of health, demographic and clinical parameters, placental biology and agnostic discovery biology) of women as they advance through pregnancy to the end of the puerperium, whether those pregnancies have normal outcomes or are complicated by one/more of the placental disorders of pregnancy (pregnancy hypertension, fetal growth restriction and stillbirth). Our clinical sites are in The Gambia (Farafenni), Kenya (Kilifi County), and Mozambique (Maputo Province). In each country, 50 non-pregnant women of reproductive age will be recruited each month for 1 year, to provide a final national sample size of 600; these women will provide culturally-, ethnically-, seasonally- and spatially-relevant control data with which to compare women with normal and complicated pregnancies. Between the three countries we will recruit ≈10,000 unselected pregnant women over 2 years. An estimated 1500 women will experience one/more placental complications over the same epoch. Importantly, as we will have accurate gestational age dating using the TraCer device, we will be able to discriminate between fetal growth restriction and preterm birth. Recruitment and follow-up will be primarily facility-based and will include women booking for antenatal care, subsequent visits in the third trimester, at time-of-disease, when relevant, during/immediately after birth and 6 weeks after birth. Conclusions To accelerate progress towards the women’s and children’s health-relevant Sustainable Development Goals, we need to understand how a variety of social, chronic disease, biomarker and pregnancy-specific determinants health interact to result in either a resilient or a compromised pregnancy for either mother or fetus/newborn, or both. This protocol has been designed to create such a depth of understanding. We are seeking funding to maintain the cohort to better understand the implications of pregnancy complications for both maternal and child health.

Pregnancy cohorts and biobanking in sub-Saharan Africa: a systematic review

“…In total, 14 cohorts were identified that met the inclusion criteria. 9 10 15–27 Eight of these were identified from the search terms and strategy outlined above, two from hand searching references of identified articles and two via expert input. For one of the four studies identified through expert input, 17 the protocol is pending publication.…”

“…Further, the above-mentioned biobanks 9 10 17 21 27 are harmonised in terms of informed consent (using a tiered informed consent model), and collection, processing and storage SOPs, which will enable future pooling of samples (currently being funded through the Missed Opportunities in Maternal and Infant Health consortium). 9 This harmonisation across operations can provide more ample opportunity for future collaboration, increases the likelihood that banked samples will be used-as well as increases the comparability of findings across studies. The most commonly collected samples in the included studies were maternal venous blood, cord blood and urine.…”

“… 5–8 However, there are challenges in applying the results from these and other high-income country studies, to low and middle-income countries, where the biological mechanisms, risk factors, environmental exposures and clinical outcomes may differ. 9 10 …”

“…Sub-Saharan Africa (SSA) has the highest burden of maternal, perinatal and child deaths globally, 11 12 yet little is known about the complex interactions between context-specific exposures and the biological mechanisms that inevitably underlie this excess in deaths. 9 10 Better understanding of these processes would guide prevention, screening and treatment measures, and has the potential to inform resource allocation and distribution, as well as health policy at regional and country levels.…”

Harmonisation of maternal health biorepositories in sub-Saharan Africa

“…Over the past decade I have had the privilege of helping establish incountry biorepositories focused on supporting research to improve maternal and newborn health. The study networks, located in five countries across SSA, 2–5 made the strategic decision to harmonise their standard operating procedures (SOPs) and informed consents despite starting years apart and having different funding sources. This enables these networks to potentially pool their samples for large-scale collaborations and to participate in research consortia, such as the Missed Opportunities in Maternal and Infant Health consortium, funded by the Bill & Melinda Gates Foundation to inform prevention of preterm birth, pre-eclampsia and stillbirth.…”