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

NCT ID: NCT05303168

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-05-31

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.

Conditions

SARS-CoV2 Infection; COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre de Recherche Médicale de Lambaréné

OTHER

Sponsor Role: collaborator

Centro de Investigação em Saúde de Manhiça

OTHER

Sponsor Role: collaborator

Universität Tübingen

OTHER

Sponsor Role: collaborator

Bernhard Nocht Institute for Tropical Medicine

OTHER_GOV

Sponsor Role: collaborator

Barcelona Institute for Global Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de Recherches Médicales de Lambaréné (CERMEL)

Lambaréné, , Gabon

Centro de Investigação em Saúde de Manhiça (CISM)

Manhiça, , Mozambique

Countries

Gabon; Mozambique

References

Figueroa-Romero A, Mendes A, Mombo-Ngoma G, Mischlinger J, Esen M, Vogler M, Mazuze M, Mombo-Nzamba L, Mbadinga B, Sanz S, Ramharter M, Saute F, Nhampossa T, Menendez C, Gonzalez R. Prevalence and impact of SARS-CoV-2 infection on maternal and infant health in African populations: protocol of a multicentre prospective cohort study (MA-CoV project). BMJ Open. 2023 May 22;13(5):e067083. doi: 10.1136/bmjopen-2022-067083.

Reference Type: BACKGROUND

PMID: 37217271 (View on PubMed)

Gonzalez R, Nhampossa T, Figueroa-Romero A, Mendes A, Mazuze M, Garcia-Otero L, Sevene E, Piqueras M, Egri N, Bedini JL, Saute F, Menendez C. SARS-CoV-2 Seropositivity and HIV Viral Load Among Mozambican Pregnant Women. J Acquir Immune Defic Syndr. 2023 Feb 1;92(2):115-121. doi: 10.1097/QAI.0000000000003120. Epub 2022 Oct 26.

Reference Type: RESULT

PMID: 36287578 (View on PubMed)

Other Identifiers

RIA2020EF-2956

Identifier Type: -

Identifier Source: org_study_id