Clinical trial NCT05303168: Prevalence and Impact of COVID-19 on Maternal and Infant Health in African Populations
Official title: Prevalence and Impact of SARS-CoV-2 Infection on Maternal and Infant Health in African Populations (MA-CoV)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
COVID-19
Keywords: SARS-CoV-2
COVID-19
Pregnancy
Perinatal
Sub-Saharan Africa
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
Collaborators: name: Centre de Recherche Médicale de Lambaréné
name: Centro de Investigação em Saúde de Manhiça
name: Universität Tübingen
name: Bernhard Nocht Institute for Tropical Medicine
First posted: 2022-03-31
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be pregnant women of all gravidities attending the antenatal care (ANC) clinics of the study sites in Gabon and Mozambique.

Inclusion of legal minors will follow local national guidelines from Gabon and Mozambique. If the woman is under the legal age of maturity, she will sign the assent form and a legal guardian of the woman will sign the informed consent form.

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.


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

Primary outcomes:
measure: Prevalence of antibodies (Ig G and/or Ig M positive) against SARS-CoV-2 among pregnant women at delivery
timeFrame: 7 months
Secondary outcomes:
measure: Incidence of SARS-CoV-2 infection during pregnancy
timeFrame: 7 months
measure: Maternal and neonatal morbidity due to SARS-CoV-2 infection during pregnancy
timeFrame: 7 months
measure: Maternal and neonatal mortality due to SARS-CoV-2 infection during pregnancy
timeFrame: 7 months
measure: Prevalence of pregnancy and perinatal adverse outcomes
timeFrame: 7 months
measure: Rate of vertical transmission of SARS-CoV-2 from infected mothers to their offspring, during the prenatal and perinatal period
timeFrame: 7 months
measure: CD4 cell counts
timeFrame: 7 months
measure: HIV viral load
timeFrame: 7 months
measure: Frequency of malaria parasitaemia at delivery (from maternal sample collected at delivery)
timeFrame: 7 months
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Centre de Recherches Médicales de Lambaréné (CERMEL)
city: Manhiça
country: Mozambique
facility: Centro de Investigação em Saúde de Manhiça (CISM)
Study officials:
References:
citation: 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.
citation: 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.