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SARS-CoV2 InfectionMA-CoVNCT05303168

Prevalence and Impact of COVID-19 on Maternal and Infant Health in African Populations

An observational study of SARS-CoV2 Infection and COVID-19, run by Barcelona Institute for Global Health at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is growing evidence that COVID-19 threatens maternal and perinatal health. Pregnant women are at higher risk of severe complications (severe pneumonia, hospitalizations, intensive care unit admission, invasive mechanical ventilation, extracorporeal membrane oxygenation) and death compared to age-matched… Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
SARS-CoV2 Infection, COVID-19
How many people
1,000 participants
Where
2 sitesin 2 countries
Study dates
1 Jul 2021to 31 May 2024
How long will I take part?
7 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Child, Adult, Older adult

Study population: The study population will be pregnant women of all gravidities attending the antenatal care (ANC) clinics of the study sites in Gabon and Mozambique. Inclusion of legal minors will follow local national guidelines from Gabon and Mozambique. If the woman is under the legal age of maturity, she will sign the assent form and a legal guardian of the woman will sign the informed consent form.

Who may be able to join

  • Permanent resident in the study area
  • Agreement to deliver in the study site's maternity(ies) wards

Who cannot join

  • Planning to move out the study area in the following 7 months from enrolment

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Gabon1 site

  • Centre de Recherches Médicales de Lambaréné (CERMEL)

    Lambaréné

Other trials in Gabon

Mozambique1 site

  • Centro de Investigação em Saúde de Manhiça (CISM)

    Manhiça

Other trials in Mozambique

About this study

Official title: Prevalence and Impact of SARS-CoV-2 Infection on Maternal and Infant Health in African Populations (MA-CoV)

There is growing evidence that COVID-19 threatens maternal and perinatal health. Pregnant women are at higher risk of severe complications (severe pneumonia, hospitalizations, intensive care unit admission, invasive mechanical ventilation, extracorporeal membrane oxygenation) and death compared to age-matched non-pregnant women. On the other hand, the number of confirmed COVID-19 cases reported in sub-Saharan Africa (SSA) continues to increase, where the highest maternal mortality rates in the world are registered. The World Health Organization (WHO) estimates that this region alone accounted for roughly two-thirds (196 000) of all maternal deaths in 2017, which among other reasons is explained by the inequalities in access to quality antenatal care (ANC) services and the low numbers of skilled health workers in the region. The spread of SARS-CoV-2 in SSA is threatening the already fragile health services, affecting mainly the most vulnerable populations such as pregnant women.

This project aims to describe the burden and effects of SARS-CoV-2 infection during pregnancy in women living in malaria endemic areas and high prevalence of HIV infection. Pregnant women attending ANC clinics in selected sites from Libreville and Lambaréné (Gabon) and Manhiça (Mozambique) will be enrolled in a cohort study to determine the frequency of SARS-CoV-2 infection and COVID-19 during pregnancy and its effects on maternal and neonatal health. Participants will be tested for SARS-CoV-2 infection whenever reporting respiratory symptoms suggestive of COVID-19 during routine ANC follow-up and six weeks after the end of pregnancy. The presence of antibodies (IgG/IgM) against SARS CoV-2 in blood samples will be determined. The clinical presentation of COVID-19 in pregnancy will be also characterised, and the incidence of infection during pregnancy and the risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection and the frequency of mother- to- child transmission of SARS-CoV-2 will be assessed.

The findings of this project will contribute to the understanding of the impact of SARS-CoV-2 and COVID-19 among pregnant women living in SSA countries where malaria and HIV infections are highly prevalent.

Keywords
SARS-CoV-2, COVID-19, Pregnancy, Perinatal, Sub-Saharan Africa
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of antibodies (Ig G and/or Ig M positive) against SARS-CoV-2 among pregnant women at delivery

    Measured: 7 months

Secondary outcomes (8)

  1. Incidence of SARS-CoV-2 infection during pregnancy

    Measured: 7 months

  2. Maternal and neonatal morbidity due to SARS-CoV-2 infection during pregnancy

    Measured: 7 months

  3. Maternal and neonatal mortality due to SARS-CoV-2 infection during pregnancy

    Measured: 7 months

  4. Prevalence of pregnancy and perinatal adverse outcomes

    Measured: 7 months

  5. Rate of vertical transmission of SARS-CoV-2 from infected mothers to their offspring, during the prenatal and perinatal period

    Measured: 7 months

  6. CD4 cell counts

    Measured: 7 months

  7. HIV viral load

    Measured: 7 months

  8. Frequency of malaria parasitaemia at delivery (from maternal sample collected at delivery)

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start1 Jul 2021
  3. Primary completion5 Jul 2023
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (actual)
Target duration
7 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05303168
Sponsor's protocol ID
RIA2020EF-2956
Acronym
MA-CoV
Status last verified
Sep 2024
First submitted
10 Mar 2022
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Figueroa-Romero A, Mendes A, Mombo-Ngoma G, Mischlinger J, Esen M, Vogler M, Mazuze M, Mombo-Nzamba L, Mbadinga B, Sanz S, Ramharter M, Saute F, Nhampossa T, Menendez C, Gonzalez R. Prevalence and impact of SARS-CoV-2 infection on maternal and infant health in African populations: protocol of a multicentre prospective cohort study (MA-CoV project). BMJ Open. 2023 May 22;13(5):e067083. doi: 10.1136/bmjopen-2022-067083.

    PubMed 37217271

  • Gonzalez R, Nhampossa T, Figueroa-Romero A, Mendes A, Mazuze M, Garcia-Otero L, Sevene E, Piqueras M, Egri N, Bedini JL, Saute F, Menendez C. SARS-CoV-2 Seropositivity and HIV Viral Load Among Mozambican Pregnant Women. J Acquir Immune Defic Syndr. 2023 Feb 1;92(2):115-121. doi: 10.1097/QAI.0000000000003120. Epub 2022 Oct 26.

    PubMed 36287578

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV2 Infection and COVID-19, run by Barcelona Institute for Global Health at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Gabon, Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of antibodies (Ig G and/or Ig M positive) against SARS-CoV-2 among pregnant women at delivery (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05303168, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.

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