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

Completed

• Conditions: Pregnancy Related; Covid19
• Interventions: Other: No Intervention

• Registration Number: NCT05409274
• Lead Sponsor: St George's, University of London

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.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-08
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6635

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women	No Intervention	Pregnant women enrolled across 5 country study sites at any point during pregnancy, up to and including the day of delivery.

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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	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).
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	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.

Trial Locations

Locations (5)

MRC Unit The Gambia at LSHTM; 🇬🇲 Fajara, Gambia

Aga Khan University; 🇰🇪 Nairobi, Kenya

MRC/UVRI; 🇺🇬 Entebbe, Uganda

University of Malawi; 🇲🇼 Zomba, Malawi

Fundação Manhiça; 🇲🇿 Manhiça, Mozambique