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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05303168
Acronym
MA-CoV
Enrollment
1000
Registered
2022-03-31
Start date
2021-07-01
Completion date
2024-05-31
Last updated
2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-CoV2 Infection

Keywords

SARS-CoV-2, COVID-19, Pregnancy, Perinatal, Sub-Saharan Africa

Brief summary

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.

Interventions

None listed

Sponsors

Centre de Recherche Médicale de Lambaréné
CollaboratorOTHER
Centro de Investigação em Saúde de Manhiça
CollaboratorOTHER
Universität Tübingen
CollaboratorOTHER
Bernhard Nocht Institute for Tropical Medicine
CollaboratorOTHER_GOV
Barcelona Institute for Global Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE

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

Design outcomes

Primary

MeasureTime frame
Prevalence of antibodies (Ig G and/or Ig M positive) against SARS-CoV-2 among pregnant women at delivery7 months

Secondary

MeasureTime frame
Prevalence of pregnancy and perinatal adverse outcomes7 months
Incidence of SARS-CoV-2 infection during pregnancy7 months
Maternal and neonatal morbidity due to SARS-CoV-2 infection during pregnancy7 months
Maternal and neonatal mortality due to SARS-CoV-2 infection during pregnancy7 months
Rate of vertical transmission of SARS-CoV-2 from infected mothers to their offspring, during the prenatal and perinatal period7 months
CD4 cell counts7 months
HIV viral load7 months
Frequency of malaria parasitaemia at delivery (from maternal sample collected at delivery)7 months

Countries

Gabon, Mozambique

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026