Clinical trial NCT04779749: Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19
Official title: Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19 : an International Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 10925
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include all 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Preterm delivery
timeFrame: 5 minutes
measure: Preeclampsia
timeFrame: 5 minutes
measure: Eclampsia
timeFrame: 5 minutes
measure: Hemolysis Elevated Liver enzymes Low Platelets Syndrome (HELLP)
timeFrame: 5 minutes
measure: Number of participants with Cesarean delivery (CD)
timeFrame: 5 minutes
measure: Percentage of participants with Cesarean delivery (CD)
timeFrame: 5 minutes
measure: Deep venous thrombosis
timeFrame: 5 minutes
measure: Pulmonary embolism
timeFrame: 5 minutes
measure: Pregnancy loss at less than 24 weeks' gestation
timeFrame: 5 minutes
measure: Intrauterine Fetal Demise (IUFD)
timeFrame: 5 minutes
measure: Maternal death
timeFrame: 5 minutes
measure: Low birth weight
timeFrame: 5 minutes
measure: Number of participants with Neonatal intensive care unit (NICU) admission
timeFrame: 5 minutes
measure: Percentage of participants with Neonatal intensive care unit (NICU) admission
timeFrame: 5 minutes
measure: Number of participants with APGAR score (Activity, Pulse, Grimace, Appearance, Respiration score) at 5 minutes < 7:
timeFrame: 5 minutes
measure: Percentage of participants with APGAR score (Activity, Pulse, Grimace, Appearance, Respiration score) at 5 minutes < 7:
timeFrame: 5 minutes
measure: Number of participants with Respiratory distress at birth
timeFrame: 5 minutes
measure: Percentage of participants with Respiratory distress at birth
timeFrame: 5 minutes
measure: Neonatal death
timeFrame: 5 minutes
Secondary outcomes:
measure: Number of participants with Delivery < 32 weeks
timeFrame: 5 minutes
measure: Percentage of participants with Delivery < 32 weeks
timeFrame: 5 minutes
measure: Number of participants with Spontaneous delivery < 37 weeks
timeFrame: 5 minutes
measure: Percentage of participants with Spontaneous delivery < 37 weeks
timeFrame: 5 minutes
measure: Number of participants with Fetal distress
timeFrame: 5 minutes
measure: Percentage of participants with Fetal distress
timeFrame: 5 minutes
measure: Number of participants with Unscheduled cesarean delivery
timeFrame: 5 minutes
measure: Percentage of participants with Unscheduled cesarean delivery
timeFrame: 5 minutes
measure: Postpartum hemorrhage
timeFrame: 5 minutes
measure: Number of participants with Intraventricular hemorrhage
timeFrame: 5 minutes
measure: Percentage of participants with Intraventricular hemorrhage
timeFrame: 5 minutes
measure: Umbilical cord pH
timeFrame: 5 minutes
measure: Small for gestational age (SGA)
timeFrame: 5 minutes
measure: Large for gestational age (LGA)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Clamart
country: France
facility: Antoine Béclère Hospital
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
Study officials:
affiliation: CHU Brugmann
name: Jacques Jani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.