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PregnancyELIKYA COVIDNCT04432779

Impact of COVID-19 Infection During Pregnancy on Newborns and Young Children

An observational study of Pregnancy and Covid-19, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life. Read more about this study

Who is it for?
Any age
Conditions the study is for
Pregnancy, Covid-19
How many people
1,362 participants
Where
1 siteBelgium
Study dates
25 May 2020to 1 Mar 2022
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
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All women who deliver in the CHU St Pierre and children born to positive mothers and controls matched on gestational age and ethnicity

Who may be able to join

  • For pregnant women, all women who deliver in the CHU St Pierre, with oral consent.
  • For children follow up: children born to positive mothers and matched controls after written consent

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • CHU SAINT Pierre

    Brussels, 1000

Other trials in Belgium

About this study

Official title: Impact of SARS-CoV-2 Infection During Pregnancy on Newborns and Young Children

This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life.

Read the detailed description

All pregnant women will be tested for serology during each trimester of pregnancy and at delivery, together with a nasal swab. Children born to women with positive sawb or serology will be followed up for 3 years together with a control child born to negative mother.

In positive mothers, maternal antibodies at delivery will be characterized, placental transfer will be assessed. Persistence of antibodies in children at the age of 1 month and presence of antibodies in breast milk will be measured.

Occurence of premature birth, low birth weight, miscarriage, congenital malformations will be compared in positive and negative mothers. Follow up of children over the first 3 years of life will assess difference in susceptibility to infections and neurological developement in both groups.

Conditions
Pregnancy, Covid-19
Being tested
no intervention
Keywords
Covid-19, Pregnancy, antibodies, congenital SARS infection, breast milk
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    no intervention

Study groups in NCT04432779
Study groupRoleWhat they receive
Women tested positive to SARS-CoV-2 during pregnancyAll women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included. Follow up end at 1 month post delivery.
Receives: Other: no intervention
Women tested negative to SARS-CoV-2 during pregnancyAll women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included. No follow up after delivery.
Receives: Other: no intervention
Newborns from women tested positiveNewborns born to mothers who had a positive nasal swab or a positive serology during pregnancy or at delivery and who consented the follow up study. Follow up end at 3 years of age.
Receives: Other: no intervention
Newborns from women tested negativeNewborns born to mothers who had no COVID-19 infection during pregnancy or at delivery and who consented the follow up study. These control children will be matched with children from the other group for gestational age and ethnicity. Follow up end at 3 years of age.
Receives: Other: no intervention

What is being measured

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

  1. Outcome of pregnancy

    Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis

    Measured: Up to the delivery

Secondary outcomes (6)

  1. Prevalence of positive serology to SARS-CoV-2 at delivery

    Measure of antibodies in maternal serum at delivery

    Measured: At the delivery

  2. Transplacental transfer of antibodies to SARS-CoV-2

    Measure the ratio of cord blood antibodies on maternal antibodies titers

    Measured: At the delivery

  3. To characterize placental alterations related to SARS-CoV-2 infection

    Placental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy

    Measured: At the delivery

  4. Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers

    Measured: At 1 month post delivery

  5. To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life

    Measure of antibodies in cord blood and at the age of 1 month

    Measured: Up to 1 month post delivery

  6. Clinical evolution of the children

    Occurence of infectious disease, neurological development, growth

    Measured: Up to 3 years

Timeline

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

  1. First posted16 Jun 2020
  2. Study start25 May 2020
  3. Primary completion6 Oct 2020
  4. Study completion1 Mar 2022

Why it stopped: Not enough financial and human resources

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
1,362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04432779
Sponsor's protocol ID
Elikya Covid
Acronym
ELIKYA COVID
Status last verified
Aug 2024
First submitted
15 Jun 2020
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dashraath P, Wong JLJ, Lim MXK, Lim LM, Li S, Biswas A, Choolani M, Mattar C, Su LL. Coronavirus disease 2019 (COVID-19) pandemic and pregnancy. Am J Obstet Gynecol. 2020 Jun;222(6):521-531. doi: 10.1016/j.ajog.2020.03.021. Epub 2020 Mar 23.

    PubMed 32217113

  • Di Mascio D, Khalil A, Saccone G, Rizzo G, Buca D, Liberati M, Vecchiet J, Nappi L, Scambia G, Berghella V, D'Antonio F. Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020 May;2(2):100107. doi: 10.1016/j.ajogmf.2020.100107. Epub 2020 Mar 25.

    PubMed 32292902

  • Alzamora MC, Paredes T, Caceres D, Webb CM, Valdez LM, La Rosa M. Severe COVID-19 during Pregnancy and Possible Vertical Transmission. Am J Perinatol. 2020 Jun;37(8):861-865. doi: 10.1055/s-0040-1710050. Epub 2020 Apr 18.

    PubMed 32305046

  • Muldoon KM, Fowler KB, Pesch MH, Schleiss MR. SARS-CoV-2: Is it the newest spark in the TORCH? J Clin Virol. 2020 Jun;127:104372. doi: 10.1016/j.jcv.2020.104372. Epub 2020 Apr 14.

    PubMed 32335336

  • Dauby N, Goetghebuer T, Kollmann TR, Levy J, Marchant A. Uninfected but not unaffected: chronic maternal infections during pregnancy, fetal immunity, and susceptibility to postnatal infections. Lancet Infect Dis. 2012 Apr;12(4):330-40. doi: 10.1016/S1473-3099(11)70341-3. Epub 2012 Feb 24.

    PubMed 22364680

  • Goetghebuer T, Smolen KK, Adler C, Das J, McBride T, Smits G, Lecomte S, Haelterman E, Barlow P, Piedra PA, van der Klis F, Kollmann TR, Lauffenburger DA, Alter G, Levy J, Marchant A. Initiation of Antiretroviral Therapy Before Pregnancy Reduces the Risk of Infection-related Hospitalization in Human Immunodeficiency Virus-exposed Uninfected Infants Born in a High-income Country. Clin Infect Dis. 2019 Mar 19;68(7):1193-1203. doi: 10.1093/cid/ciy673.

    PubMed 30215689

  • McHenry MS, McAteer CI, Oyungu E, McDonald BC, Bosma CB, Mpofu PB, Deathe AR, Vreeman RC. Neurodevelopment in Young Children Born to HIV-Infected Mothers: A Meta-analysis. Pediatrics. 2018 Feb;141(2):e20172888. doi: 10.1542/peds.2017-2888.

    PubMed 29374109

  • Vohr BR, Poggi Davis E, Wanke CA, Krebs NF. Neurodevelopment: The Impact of Nutrition and Inflammation During Preconception and Pregnancy in Low-Resource Settings. Pediatrics. 2017 Apr;139(Suppl 1):S38-S49. doi: 10.1542/peds.2016-2828F.

    PubMed 28562247

  • Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available.

    PubMed 32283004

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Covid-19, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

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: stopped early, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 was stopped early (reason given: Not enough financial and human resources). Results are not available in the source record.

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?

Outcome of pregnancy (time frame: Up to the delivery). 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 NCT04432779, which also lists 9 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 26 Aug 2024.

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