Clinical trial NCT04432779: Impact of COVID-19 Infection During Pregnancy on Newborns and Young Children
Official title: Impact of SARS-CoV-2 Infection During Pregnancy on Newborns and Young Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Covid-19
Keywords: Covid-19
Pregnancy
antibodies
congenital SARS infection
breast milk
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: Institute for Medical Immunology (IMI)
name: Laboratoire Hospitalier Universitaire de Bruxelles (LHUB)
First posted: 2020-06-16
Enrollment: 1362
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* none

Primary outcomes:
measure: Outcome of pregnancy
timeFrame: Up to the delivery
Secondary outcomes:
measure: Prevalence of positive serology to SARS-CoV-2 at delivery
timeFrame: At the delivery
measure: Transplacental transfer of antibodies to SARS-CoV-2
timeFrame: At the delivery
measure: To characterize placental alterations related to SARS-CoV-2 infection
timeFrame: At the delivery
measure: Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers
timeFrame: At 1 month post delivery
measure: To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life
timeFrame: Up to 1 month post delivery
measure: Clinical evolution of the children
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU SAINT Pierre
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Tessa Goetghebuer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.