Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19

NCT ID: NCT04779749

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10925 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-08

Study Completion Date

2021-09-01

Brief Summary

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A new coronavirus, called severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) appeared in Wuhan, China and it arrived to Europe 2-3 months later. It infected millions of persons and led to the death of thousands until May 2020 where numbers of infections per week decreased significantly. However, starting September, number of infections started to escalate again and continued to rise until now.

Hundreds of good quality articles were published during this period to study the relationship and effects of this virus on pregnancy and vice versa, as well as to determine the adverse neonatal and obstetrical outcomes following the infection. In a case-control study using propensity score matching at the level of age, body mass index and comorbidities (diabetes, hypertension, asthma), pregnant women over 20 week's gestation had significantly higher risk for intensive care unit stay, endotracheal intubation, hospitalization for disease related symptoms and need for oxygen therapy. A new systematic review also demonstrated increased risk for ICU admission in pregnant women compared to non-pregnant women and to non-infected pregnant women.

On the other hand, many researchers have demonstrated that the rates of preterm delivery and cesarean delivery have increased as well, others reported a close relation between SARS-CoV2 infection and preeclampsia or preeclampsia like condition. Enormous effort was done in order to understand adverse outcomes related to this infection, however, most studies included patients in the third or late second trimester. Few studies stratified adverse outcomes of the patients according to the trimester of infection.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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COVID positive <20 weeks

Case groups 1 will include pregnant patients infected by SARS-CoV2 before 20 weeks' gestation during the period starting on February 1st 2020 and ending on November 30th 2020.

Data extraction from medical files

Intervention Type OTHER

Data extraction from medical files

COVID positive >20 weeks

Case groups 2 will include pregnant patients infected by SARS-CoV2 after 20 weeks' gestation during the period starting on February 1st 2020 and ending on November 30th 2020.

Data extraction from medical files

Intervention Type OTHER

Data extraction from medical files

Control

Patients not infected by SARS-CoV2 during pregnancy during the period starting on February 1st 2020 and ending on November 30th 2020

Data extraction from medical files

Intervention Type OTHER

Data extraction from medical files

Interventions

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Data extraction from medical files

Data extraction from medical files

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Pregnant women with viable fetus after 10 weeks' gestation and known pregnancy outcome during the period starting on February 1st 2020 and ending on November 30th 2020.

Exclusion Criteria

All ongoing pregnancies, those with unknown outcomes, those terminated medically or voluntary, as well as patients with spontaneous abortion before the 11th gestational week.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jani Jacques

Head of Gynecology-Obstetrics Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacques Jani, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

Antoine Béclère Hospital

Clamart, , France

Site Status

Hôpital Louis Mourier

Colombes, , France

Site Status

Fondazione Policlinico Universitario Agostino Gemelli

Roma, , Italy

Site Status

Countries

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Belgium France Italy

References

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Badr DA, Mattern J, Carlin A, Cordier AG, Maillart E, El Hachem L, El Kenz H, Andronikof M, De Bels D, Damoisel C, Preseau T, Vignes D, Cannie MM, Vauloup-Fellous C, Fils JF, Benachi A, Jani JC, Vivanti AJ. Are clinical outcomes worse for pregnant women at >/=20 weeks' gestation infected with coronavirus disease 2019? A multicenter case-control study with propensity score matching. Am J Obstet Gynecol. 2020 Nov;223(5):764-768. doi: 10.1016/j.ajog.2020.07.045. Epub 2020 Jul 27. No abstract available.

Reference Type BACKGROUND
PMID: 32730899 (View on PubMed)

Allotey J, Stallings E, Bonet M, Yap M, Chatterjee S, Kew T, Debenham L, Llavall AC, Dixit A, Zhou D, Balaji R, Lee SI, Qiu X, Yuan M, Coomar D, Sheikh J, Lawson H, Ansari K, van Wely M, van Leeuwen E, Kostova E, Kunst H, Khalil A, Tiberi S, Brizuela V, Broutet N, Kara E, Kim CR, Thorson A, Oladapo OT, Mofenson L, Zamora J, Thangaratinam S; for PregCOV-19 Living Systematic Review Consortium. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020 Sep 1;370:m3320. doi: 10.1136/bmj.m3320.

Reference Type BACKGROUND
PMID: 32873575 (View on PubMed)

Khalil A, von Dadelszen P, Draycott T, Ugwumadu A, O'Brien P, Magee L. Change in the Incidence of Stillbirth and Preterm Delivery During the COVID-19 Pandemic. JAMA. 2020 Jul 10;324(7):705-6. doi: 10.1001/jama.2020.12746. Online ahead of print.

Reference Type BACKGROUND
PMID: 32648892 (View on PubMed)

Prabhu M, Cagino K, Matthews KC, Friedlander RL, Glynn SM, Kubiak JM, Yang YJ, Zhao Z, Baergen RN, DiPace JI, Razavi AS, Skupski DW, Snyder JR, Singh HK, Kalish RB, Oxford CM, Riley LE. Pregnancy and postpartum outcomes in a universally tested population for SARS-CoV-2 in New York City: a prospective cohort study. BJOG. 2020 Nov;127(12):1548-1556. doi: 10.1111/1471-0528.16403. Epub 2020 Aug 13.

Reference Type BACKGROUND
PMID: 32633022 (View on PubMed)

Berghella V, Boelig R, Roman A, Burd J, Anderson K. Decreased incidence of preterm birth during coronavirus disease 2019 pandemic. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100258. doi: 10.1016/j.ajogmf.2020.100258. Epub 2020 Oct 15. No abstract available.

Reference Type BACKGROUND
PMID: 33083779 (View on PubMed)

Mendoza M, Garcia-Ruiz I, Maiz N, Rodo C, Garcia-Manau P, Serrano B, Lopez-Martinez RM, Balcells J, Fernandez-Hidalgo N, Carreras E, Suy A. Pre-eclampsia-like syndrome induced by severe COVID-19: a prospective observational study. BJOG. 2020 Oct;127(11):1374-1380. doi: 10.1111/1471-0528.16339. Epub 2020 Jun 21.

Reference Type BACKGROUND
PMID: 32479682 (View on PubMed)

Cosma S, Carosso AR, Cusato J, Borella F, Carosso M, Bovetti M, Filippini C, D'Avolio A, Ghisetti V, Di Perri G, Benedetto C. Coronavirus disease 2019 and first-trimester spontaneous abortion: a case-control study of 225 pregnant patients. Am J Obstet Gynecol. 2021 Apr;224(4):391.e1-391.e7. doi: 10.1016/j.ajog.2020.10.005. Epub 2020 Oct 8.

Reference Type BACKGROUND
PMID: 33039396 (View on PubMed)

Other Identifiers

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PregOutCOV

Identifier Type: -

Identifier Source: org_study_id

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