An observational study in SARS-CoV2 Infection and COVID-19, sponsored by Barcelona Institute for Global Health. Completed at 2 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Barcelona Institute for Global Health · Observational
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.
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.
Exclusion Criteria:
Prevalence of antibodies (Ig G and/or Ig M positive) against SARS-CoV-2 among pregnant women at delivery
Time frame: 7 months
Incidence of SARS-CoV-2 infection during pregnancy
Time frame: 7 months
Maternal and neonatal morbidity due to SARS-CoV-2 infection during pregnancy
Time frame: 7 months
Maternal and neonatal mortality due to SARS-CoV-2 infection during pregnancy
Time frame: 7 months
Prevalence of pregnancy and perinatal adverse outcomes
Time frame: 7 months
Rate of vertical transmission of SARS-CoV-2 from infected mothers to their offspring, during the prenatal and perinatal period
Time frame: 7 months
CD4 cell counts
Time frame: 7 months
HIV viral load
Time frame: 7 months
Frequency of malaria parasitaemia at delivery (from maternal sample collected at delivery)
Time frame: 7 months
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Barcelona Institute for Global Health