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

COVID-19 Clinical Trial

— MA-CoV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05303168
• Other study ID #: RIA2020EF-2956
• Status: Active, not recruiting
• Start date: July 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: Barcelona Institute for Global Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: May 31, 2024
• Est. primary completion date: July 5, 2023
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV2 Infection

Locations

Country	Name	City	State
Gabon	Centre de Recherches Médicales de Lambaréné (CERMEL)	Lambaréné
Mozambique	Centro de Investigação em Saúde de Manhiça (CISM)	Manhiça

Sponsors (5)

Lead Sponsor	Collaborator
Barcelona Institute for Global Health	Bernhard Nocht Institute for Tropical Medicine, Centre de Recherche Médicale de Lambaréné, Centro de Investigação em Saúde de Manhiça, Universität Tübingen

Countries where clinical trial is conducted

Gabon,  Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of antibodies (Ig G and/or Ig M positive) against SARS-CoV-2 among pregnant women at delivery		7 months
Secondary	Incidence of SARS-CoV-2 infection during pregnancy		7 months
Secondary	Maternal and neonatal morbidity due to SARS-CoV-2 infection during pregnancy		7 months
Secondary	Maternal and neonatal mortality due to SARS-CoV-2 infection during pregnancy		7 months
Secondary	Prevalence of pregnancy and perinatal adverse outcomes		7 months
Secondary	Rate of vertical transmission of SARS-CoV-2 from infected mothers to their offspring, during the prenatal and perinatal period		7 months
Secondary	CD4 cell counts		7 months
Secondary	HIV viral load		7 months
Secondary	Frequency of malaria parasitaemia at delivery (from maternal sample collected at delivery)		7 months