Clinical trial NCT05409274: Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)
Official title: Understanding COVID-19 Infections in Pregnant Women and Their Babies in Uganda, Kenya, Malawi, the Gambia and Mozambique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Pregnancy Related
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Fundação Manhiça
name: Aga Khan University
name: MU-JHU CARE
name: University of Liverpool
name: King's College London
name: Makerere University
name: University of Bergen
name: University of Malawi
First posted: 2022-06-08
Enrollment: 6635
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women are recruited into the study either during antenatal visits, or during labour (convenience sampling). All participant women will have a cord blood sample taken at the time of delivery. In addition, some of the study sites, as part of their individual cohorts , include blood sampling from the same individual at different time points during pregnancy as well . If serial sampling is being performed, intervals between each round of collecting specimens should be of a period of greater than 21 days (the half-life of IgG is approximately 42days).

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: 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
timeFrame: through study completion, an average of 1 year
measure: Estimate the fraction of asymptomatic or pre-symptomatic/ subclinical infections in the population of pregnant women sampled.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Fajara
country: Gambia
facility: MRC Unit The Gambia at LSHTM
city: Nairobi
country: Kenya
facility: Aga Khan University
city: Zomba
country: Malawi
facility: University of Malawi
city: Manhiça
country: Mozambique
facility: Fundação Manhiça
city: Entebbe
country: Uganda
facility: MRC/UVRI
Study officials:
affiliation: St George's, University of London
name: Kirsty Le Doare
role: PRINCIPAL_INVESTIGATOR
References: