NCT04432779

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,362

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

June 15, 2020

Last Update Submit

August 22, 2024

Conditions

PregnancyCovid-19

Keywords

Covid-19Pregnancyantibodiescongenital SARS infectionbreast milk

Outcome Measures

Primary Outcomes (1)

  • Outcome of pregnancy

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

    Up to the delivery

Secondary Outcomes (6)

  • Prevalence of positive serology to SARS-CoV-2 at delivery

    At the delivery

  • Transplacental transfer of antibodies to SARS-CoV-2

    At the delivery

  • To characterize placental alterations related to SARS-CoV-2 infection

    At the delivery

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

    At 1 month post delivery

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

    Up to 1 month post delivery

  • +1 more secondary outcomes

Study Arms (4)

Women tested positive to SARS-CoV-2 during pregnancy

All 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.

Other: no intervention

Women tested negative to SARS-CoV-2 during pregnancy

All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included. No follow up after delivery.

Other: no intervention

Newborns from women tested positive

Newborns 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.

Other: no intervention

Newborns from women tested negative

Newborns 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.

Other: no intervention

Interventions

no interventionOTHER

no intervention

Newborns from women tested negativeNewborns from women tested positiveWomen tested negative to SARS-CoV-2 during pregnancyWomen tested positive to SARS-CoV-2 during pregnancy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU SAINT Pierre

Brussels, 1000, Belgium

Location

Related Publications (9)

  • 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.

    PMID: 32217113BACKGROUND

  • 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.

    PMID: 32292902BACKGROUND

  • 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.

    PMID: 32305046BACKGROUND

  • 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.

    PMID: 32335336BACKGROUND

  • 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.

    PMID: 22364680BACKGROUND

  • 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.

    PMID: 30215689BACKGROUND

  • 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.

    PMID: 29374109BACKGROUND

  • 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.

    PMID: 28562247BACKGROUND

  • 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.

    PMID: 32283004BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal specimens (placental tissue, serum, breast milk), Newborn specimens (umbilical cord blood)and infant specimens (serum)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Tessa Goetghebuer, MD PhD

    Centre Hospitalier Universitaire Saint Pierre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 16, 2020

Study Start

May 25, 2020

Primary Completion

October 6, 2020

Study Completion

March 1, 2022

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)