PregMpox

The PREGMPOX study is a 3-year prospective observational cohort with a nested case-control component designed to address critical knowledge gaps on the impact of Mpox virus (MPXV) infection during pregnancy and its consequences for maternal, fetal, and newborn health in South Kivu, Democratic Republic of Congo (DRC). Led by Professor Patrick de Marie Katoto (Université Catholique de Bukavu) and implemented through a multinational consortium involving the University of Antwerp, Universitaetsklinikum Hamburg-Eppendorf, and Makerere Lung Institute, the study represents a major regional effort to strengthen evidence on Mpox in one of the world’s most affected settings.

The primary goal is to improve understanding of how MPXV affects pregnancy outcomes, including miscarriage, stillbirth, preterm birth, and neonatal health. Specifically, the study seeks to: (1) map and monitor Mpox distribution among pregnant women through integrated surveillance and community engagement; (2) investigate the effects of infection on pregnancy outcomes, immune responses, and placental pathology; and (3) assess the safety and effectiveness of MVA-BN vaccination and MPXV therapeutics in pregnancy, including adverse effects surveillance.

PREGMPOX will recruit approximately 2,000 pregnant women across selected Mpox hotspot zones in South Kivu, including Miti-Murhesa, Nyangezi, Uvira, Kamituga, Walungu, Katana, and Bukavu. This sample size is expected to identify at least 75 MPXV-infected pregnant women and 150 matched uninfected controls, based on an estimated 5% infection prevalence. A nested placental pathology and immunology sub-study will include 50 infected and 50 control mothers. Recruitment combines active surveillance—routine antenatal screening, clinical assessments, symptom screening, and PCR confirmation—with passive surveillance through health records review and identification of previously diagnosed or vaccinated women. This dual strategy is intended to capture both symptomatic and asymptomatic infections.

Eligibility includes all pregnant women residing within participating facility catchment areas, regardless of age, with both symptomatic and asymptomatic individuals included. Exclusions include non-consent, plans to relocate, or participation in conflicting clinical trials. Ethical implementation is guided by Good Clinical Practice and the Declaration of Helsinki, with strong emphasis on informed consent and participant safety.

Methodologically, the study applies robust epidemiological and statistical approaches. Multiple logistic regression will identify infection risk factors and adverse outcomes, while Generalised Linear Mixed Models will account for clustering across health facilities. Survival analyses, including Kaplan-Meier and Cox proportional hazards models, will evaluate infection timing, delivery outcomes, and treatment effectiveness. Vaccine effectiveness will be estimated using relative risk reduction methods. These methods allow the study to evaluate both disease burden and intervention impact comprehensively.

Overall, PREGMPOX is positioned as a landmark maternal-child health and outbreak research initiative. By integrating surveillance, immunology, placental pathology, and intervention evaluation, it aims to generate urgently needed evidence to inform Mpox prevention and treatment guidelines for pregnant women in outbreak-prone, resource-limited settings. Its findings could significantly shape public health policy, vaccination strategies, and maternal care protocols for emerging infectious diseases in Africa and beyond.