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

NCT ID: NCT05409274

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6635 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Covid19 Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women

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

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* Accepts to read or to be read to and sign or fingerprint the approved study consent form
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Fundação Manhiça

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role collaborator

MU-JHU CARE

OTHER

Sponsor Role collaborator

University of Liverpool

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role collaborator

University of Malawi

OTHER

Sponsor Role collaborator

St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirsty Le Doare

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

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Aga Khan University

Nairobi, , Kenya

Site Status

University of Malawi

Zomba, , Malawi

Site Status

Fundação Manhiça

Manhiça, , Mozambique

Site Status

MRC Unit The Gambia at LSHTM

Fajara, , The Gambia

Site Status

MRC/UVRI

Entebbe, , Uganda

Site Status

Countries

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Kenya Malawi Mozambique The Gambia Uganda

Other Identifiers

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13487-10

Identifier Type: -

Identifier Source: org_study_id

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