Title: Understanding the drivers of poor maternal and newborn health outcomes: leveraging the PROMISE trial platform
Abstract: Observational data suggest sexually transmitted infections (STIs) during pregnancy are associated with a range of adverse outcomes for both mothers and infants, including preterm birth, low birthweight, and stillbirth. Evidence that screening for these STIs in pregnancy can reduce these adverse outcomes is lacking especially in low- and middle-income countries (LMIC), where syndromic STI management remains the standard approach. This strategy lacks sensitivity, as >80% of infections are asymptomatic. The PROMISE trial evaluates whether routine diagnostic testing and comprehensive management of three curable STIs, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis, within standard antenatal care can reduce adverse maternal and neonatal outcomes in a high HIV/STI prevalence setting.
PROMISE is an individually randomised controlled trial recruiting 12,780 pregnant women (6,390 per arm) from 15 antenatal clinics in Harare, Zimbabwe. Women in the intervention arm receive diagnostic testing for STIs at two timepoints during pregnancy (<24 and 32-34 weeks’ gestation), with treatment provided for those who test positive. Women in the control arm receive syndromic management. All participants are followed up within 72 hours of birth, and again at 1 and 6 weeks postpartum. The primary outcome is a composite of stillbirth, low birthweight (<2500g), and preterm birth (<37 weeks’ gestation). Secondary outcomes include individual components of the composite, proportions of women who have curable STIs diagnosed and treated in pregnancy; prelabour rupture of membranes, small for gestational age, neonatal death, conjunctivitis or sepsis within the first six weeks of life. A cost-effectiveness analysis will estimate the incremental cost per disability-adjusted life year averted. A process evaluation will explore acceptability, feasibility, contextual influences, and system-level considerations for scale-up.
Beyond the main aim of the trial, its design offers a platform off which to conduct additional investigations into the drivers of poor maternal and newborn health and long term sequelae (e.g. vaginal microbiome analysis, epidemiology of neonatal conjunctivitis, etc).
Biography: Leyla is a Research Fellow in the Clinical Research Department at LSHTM, where she coordinates the PROMISE study - a trial examining how screening for sexually transmitted infections during pregnancy influences maternal and neonatal outcomes such as prematurity, low birthweight, and stillbirth. Within this trial, she also leads a sub-study exploring how climate-related drivers, such as heat exposure and food or
water insecurity, affect those same outcomes, applying innovative systems-thinking and causal analysis tools to better understand these complex interactions.
She conducted her PhD at Ludwig Maximilian University (LMU) in Munich between 2022 and 2025, working on the ERASE‑TB study - a prospective observational cohort study evaluating novel diagnostics for early tuberculosis detection in high-burden settings across Zimbabwe, Tanzania, and Mozambique. Her doctoral research focused on methods to leverage observational cohorts to unravel complex dynamics in the natural history of tuberculosis.
With her background in biomedical engineering and medical device design, Leyla is passionate about translating rigorous data-driven research and integrating novel technological solutions into practical public health solutions. She integrates systems-based causal inference approaches to uncover actionable insights, particularly in maternal and newborn health.
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Meeting ID: 337 084 297 499 5
Passcode: ZG7hx6V3