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Completed

NCT Number: NCT05409274

Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)

Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda

Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries

Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood

Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Pregnancy Related RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

14 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Aga Khan University, Nairobi, Kenya

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About this study

This study has been set up as part of the response to the international outbreak of the novel Severe acute respiratory syndrome coronavirus 2 (SARS CoV-2). The aim of the study is to answer important questions about the impact of the novel coronavirus on pregnant women and their infants. The investigators aim to describe the sero-epidemiology and burden of COVID-19 disease among pregnant women, as well as the impact on maternal and neonatal health, by collecting epidemiological data and by collecting samples during pregnancy, labour and delivery and in the neonatal period.

Data from this study will be pooled from 5 countries; Malawi, Uganda, Mozambique, the Gambia, and Kenya to provide robust and generalisable evidence from the different regions in sub-Saharan Africa. the investigators hope that with this information, they can contribute to the evidence base for recommendations, guidance and policy decisions for the clinical management and public health response to protect pregnant women and their infants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any pregnant woman or emancipated minor at any gestation, up to and including day of delivery. Individual study sites may have their own specific inclusion/exclusion criteria which is not listed here.
  • Accepts to read or to be read to and sign or fingerprint the approved study consent form

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. To describe the seroepidemiology of SARS-CoV-2 infection among African pregnant women from 5 African countries across several waves of the COVID-19 pandemic in those countries.

    Time frame: through study completion, an average of 1 year

    The proportion of individuals who show seropositivity for SARS-CoV-2 virus. If data is collected, sero-prevalence by different groups (e.g. geography, profession, residence) will be an important sub-analysis.

Secondary outcomes

  1. To define the impact of SARS-CoV-2 infection in pregnancy adjusted for key pregnancy and neonatal outcomes as defined by the Global Alignment of Immunization safety Assessment in pregnancy (GAIA) criteria

    Time frame: through study completion, an average of 1 year

    SARS-CoV-2 positive status (by serology or by clinical signs or symptoms of COVID-19 illness which meets the World Health Organisation (WHO) case definition for probable or confirmed SARS-CoV-2 illness).

  2. Estimate the fraction of asymptomatic or pre-symptomatic/ subclinical infections in the population of pregnant women sampled.

    Time frame: through study completion, an average of 1 year

    Asymptomatic fraction (proportion of cases that are asymptomatic). The proportion of individuals who reported no symptoms of COVID-19 infection out of individuals seropositive for SARS-CoV-2.

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • Aga Khan University
  • Fundação Manhiça
  • King's College London
  • London School of Hygiene and Tropical Medicine
  • MU-JHU CARE
  • Makerere University
  • University of Bergen
  • University of Liverpool
  • University of Malawi

Registry information

Official study title

Understanding COVID-19 Infections in Pregnant Women and Their Babies in Uganda, Kenya, Malawi, the Gambia and Mozambique

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 8, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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