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

NCT05409274 | Completed

• 1 other identifier: 13487-10
• Study Type: observational
• Target: 6,635
• Locations: 5 countries
• Sites: 5

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

Conditions

Covid19; Pregnancy Related

Outcome Measures

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.

  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.

  through study completion, an average of 1 year

Secondary Outcomes (2)

• 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

  through study completion, an average of 1 year

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

  through study completion, an average of 1 year

Study Arms (1)

Pregnant women

Pregnant women enrolled across 5 country study sites at any point during pregnancy, up to and including the day of delivery.

Other: No Intervention

Interventions

No Intervention OTHER

No Intervention

Pregnant women

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may not qualify if:

• Accepts to read or to be read to and sign or fingerprint the approved study consent form

Sponsors & Collaborators

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

Study Sites (5)

Aga Khan University

Nairobi, Kenya

Location

University of Malawi

Zomba, Malawi

Location

Fundação Manhiça

Manhiça, Mozambique

Location

MRC Unit The Gambia at LSHTM

Fajara, The Gambia

Location

MRC/UVRI

Entebbe, Uganda

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cord blood samples will be taken from participants. Some sites may be able to obtain Polymerase Chain Reaction (PCR) samples from participants.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kirsty Le Doare

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 8, 2022
• Study Start: November 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

TH (1); UG (1); MA (1); KE (1); MO (1)