Prevalence and Impact of COVID-19 on Maternal and Infant Health in African Populations

Study Overview
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Brief Summary
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There is growing evidence that COVID-19 threatens maternal and perinatal health. Pregnant women are at higher risk of severe complications (severe pneumonia, hospitalizations, intensive care unit admission, invasive mechanical ventilation, extracorporeal membrane oxygenation) and death compared to age-matched non-pregnant women. On the other hand, the number of confirmed COVID-19 cases reported in sub-Saharan Africa (SSA) continues to increase, where the highest maternal mortality rates in the world are registered. The World Health Organization (WHO) estimates that this region alone accounted for roughly two-thirds (196 000) of all maternal deaths in 2017, which among other reasons is explained by the inequalities in access to quality antenatal care (ANC) services and the low numbers of skilled health workers in the region. The spread of SARS-CoV-2 in SSA is threatening the already fragile health services, affecting mainly the most vulnerable populations such as pregnant women. This project aims to describe the burden and effects of SARS-CoV-2 infection during pregnancy in women living in malaria endemic areas and high prevalence of HIV infection. Pregnant women attending ANC clinics in selected sites from Libreville and Lambaréné (Gabon) and Manhiça (Mozambique) will be enrolled in a cohort study to determine the frequency of SARS-CoV-2 infection and COVID-19 during pregnancy and its effects on maternal and neonatal health. Participants will be tested for SARS-CoV-2 infection whenever reporting respiratory symptoms suggestive of COVID-19 during routine ANC follow-up and six weeks after the end of pregnancy. The presence of antibodies (IgG/IgM) against SARS CoV-2 in blood samples will be determined. The clinical presentation of COVID-19 in pregnancy will be also characterised, and the incidence of infection during pregnancy and the risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection and the frequency of mother- to- child transmission of SARS-CoV-2 will be assessed. The findings of this project will contribute to the understanding of the impact of SARS-CoV-2 and COVID-19 among pregnant women living in SSA countries where malaria and HIV infections are highly prevalent.

Official Title
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Prevalence and Impact of SARS-CoV-2 Infection on Maternal and Infant Health in African Populations (MA-CoV)

Conditions
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SARS-CoV2 Infection, COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Permanent resident in the study area Agreement to deliver in the study site's maternity(ies) wards Exclusion Criteria: Planning to move out the study area in the following 7 months from enrolment
Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of antibodies (Ig G and/or Ig M positive) against SARS-CoV-2 among pregnant women at delivery |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SARS-CoV-2 infection during pregnancy |  | 7 months | 
| Maternal and neonatal morbidity due to SARS-CoV-2 infection during pregnancy |  | 7 months | 
| Maternal and neonatal mortality due to SARS-CoV-2 infection during pregnancy |  | 7 months | 
| Prevalence of pregnancy and perinatal adverse outcomes |  | 7 months | 
| Rate of vertical transmission of SARS-CoV-2 from infected mothers to their offspring, during the prenatal and perinatal period |  | 7 months | 
| CD4 cell counts |  | 7 months | 
| HIV viral load |  | 7 months | 
| Frequency of malaria parasitaemia at delivery (from maternal sample collected at delivery) |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, Pregnancy, Perinatal, Sub-Saharan Africa