The Zambian Preterm Birth Prevention Study (ZAPPS): Cohort characteristics at enrollment.

Marcela C Castillo,Courtney Baruch-Gravett,James A Litch,Nurain M Fuseini,Margaret P Kasaro,Bellington Vwalika,Ntazana Sindano,Bethany L Freeman,Jeffrey S A Stringer,Jennifer Winston,Benjamin H Chi,Humphrey Mwape,Joan T Price,Katelyn Rittenhouse

doi:10.12688/gatesopenres.12820.3

Abstract

Background:Sub-Saharan Africa bears a disproportionate burden of preterm birth and other adverse outcomes. A better understanding of the demographic, clinical, and biologic underpinnings of these adverse outcomes is urgently needed to plan interventions and inform new discovery. Methods:The Zambian Preterm Birth Prevention Study (ZAPPS) is a prospective observational cohort established at the Women and Newborn Hospital (WNH) in Lusaka, Zambia. We recruit pregnant women from district health centers and the WNH and offer ultrasound examination to determine eligibility. Participants receive routine obstetrical care, lab testing, midtrimester cervical length measurement, and serial fetal growth monitoring. At delivery, we assess gestational age, birthweight, vital status, and sex and assign a delivery phenotype. We collect blood, urine, and vaginal swab specimens at scheduled visits and store them in an on-site biorepository.In September 2017, enrollment of the ZAPPS Phase 1-the subject of this report-was completed. Phase 2, which is limited to HIV-uninfected women, reopened in January 2018. Results:Between August 2015 and September 2017, we screened 1784 women, of whom 1450 (81.2%) met inclusion criteria and were enrolled. The median age at enrollment was 27 years (IQR 23-32) and median gestational age was 16 weeks (IQR 13-18). Among women with a previous pregnancy (n=1042), 19% (n=194) reported a prior miscarriage. Among parous women (n=992), 41% (n=411) reported a prior preterm birth and 14% (n=126) reported a prior stillbirth. The HIV seroprevalence was 24%. Discussion:We have established a large cohort of pregnant women and newborns at the WNH to characterize the determinants of adverse birth outcomes in Lusaka, Zambia. Our overarching goal is to elucidate biological mechanisms in an effort to identify new strategies for early detection and prevention of adverse outcomes. We hope that findings from this cohort will help guide future studies, clinical care, and policy.

Highlights

Preterm birth is a global challenge impacting both developed and developing countries[1,2]
We have established a large cohort of pregnant women and Discussion: We have established a large cohort of pregnant women and newborns at the Women and Newborn Hospital (WNH) to characterize the determinants of adverse birth outcomes in Lusaka, Zambia
We hope that findings from this cohort will help guide future studies, clinical care, and policy

Summary

Introduction

Preterm birth is a global challenge impacting both developed and developing countries[1,2]. It contributes to approximately 35% of neonatal and 75% of perinatal mortality each year[3,4]. Preterm infants who survive are at an elevated risk of long-term respiratory, cardiovascular, gastrointestinal, and neurodevelopmental morbidities. These complications may affect subsequent health, growth, psychosocial functioning, and even economic capacity of these individuals[5,6,7]. The greatest burden of mortality and morbidity from preterm births occurs in low- and middle-income countries (LMICs)[8].

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