Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)
Understanding COVID-19 Infections in Pregnant Women and Their Babies in Uganda, Kenya, Malawi, the Gambia and Mozambique
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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Pregnant women
Pregnant women enrolled across 5 country study sites at any point during pregnancy, up to and including the day of delivery.
|
간섭 없음
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.
기간: 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.
|
through study completion, an average of 1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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).
|
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.
기간: 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.
|
through study completion, an average of 1 year
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Kirsty Le Doare, St George's, University of London
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 13487-10
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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