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CompletedNCT05303168MA-CoVUpdated Sep 20, 2024

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

An observational study in SARS-CoV2 Infection and COVID-19, sponsored by Barcelona Institute for Global Health. Completed at 2 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by Barcelona Institute for Global Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
Female
01

Study 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 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.

02

Conditions studied

  • SARS-CoV2 Infection
  • COVID-19

Keywords

  • SARS-CoV-2
  • COVID-19
  • Pregnancy
  • Perinatal
  • Sub-Saharan Africa
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Sampling method
Probability sample

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Planning to move out the study area in the following 7 months from enrolment
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Target follow-up
7 Months
Patient registry
Yes
05

What researchers measure

Primary outcomes

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

    Time frame: 7 months

Secondary outcomes

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

    Time frame: 7 months

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

    Time frame: 7 months

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

    Time frame: 7 months

  4. Prevalence of pregnancy and perinatal adverse outcomes

    Time frame: 7 months

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

    Time frame: 7 months

  6. CD4 cell counts

    Time frame: 7 months

  7. HIV viral load

    Time frame: 7 months

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

    Time frame: 7 months

06

Study locations

2 sites
  • Centre de Recherches Médicales de Lambaréné (CERMEL)
    Lambaréné, Gabon
  • Centro de Investigação em Saúde de Manhiça (CISM)
    Manhiça, Mozambique
07

References and documents

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 ↗
08

Registry details

Key details

Study ID
NCT05303168
Lead sponsor
Barcelona Institute for Global Health
Collaborators
Centre de Recherche Médicale de Lambaréné, Centro de Investigação em Saúde de Manhiça, Universität Tübingen, Bernhard Nocht Institute for Tropical Medicine
Responsible party
Sponsor
First posted
Mar 31, 2022
Start date
Jul 1, 2021
Primary completion
Jul 5, 2023
Completion
May 31, 2024
Last update
Sep 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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