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

NCT04779749 | Completed

• 1 other identifier: PregOutCOV
• Study Type: observational
• Target: 10,925
• Locations: 3 countries
• Sites: 4

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (19)

• Preterm delivery

  Delivery at a gestational age \< 37 weeks

  5 minutes

• Preeclampsia

  Preeclampsia is defined as elevated blood pressure (Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg on at least 2 occasions at least 4 hours apart after 20 weeks of gestation in a previously normotensive patient) and the new onset of 1 or more of the following: * Proteinuria ≥0.3 g in a 24-hour urine specimen or protein/creatinine ratio ≥0.3 (mg/mg) (30 mg/mmol) in a random urine specimen or dipstick ≥2+ if a quantitative measurement is unavailable * Platelet count \<100,000/microL * Serum creatinine \>1.1 mg/dL (97.2 micromol/L) or doubling of the creatinine concentration in the absence of other renal disease * Liver transaminases at least twice the upper limit of the normal concentrations for the local laboratory * Pulmonary edema * New-onset and persistent headache not accounted for by alternative diagnoses and not responding to usual doses of analgesics * Visual symptoms (eg, blurred vision, flashing lights or sparks, scotomata)

  5 minutes

• Eclampsia

  Eclampsia is defined by the occurrence of a grand mal seizure in a woman with preeclampsia in the absence of other neurologic conditions that could cause seizure.

  5 minutes

• Hemolysis Elevated Liver enzymes Low Platelets Syndrome (HELLP)

  HELLP syndrome is considered to be a serious complication or variant of preeclampsia in pregnant women.

  5 minutes

• Number of participants with Cesarean delivery (CD)

  Number of participants with Cesarean delivery (CD)

  5 minutes

• Percentage of participants with Cesarean delivery (CD)

  Percentage of participants with Cesarean delivery (CD)

  5 minutes

• Deep venous thrombosis

  diagnosed by imaging tools such as venous Doppler ultrasound of the lower limbs

  5 minutes

• Pulmonary embolism

  diagnosed by imaging tools such as angio-CT scan of the thorax.

  5 minutes

• Pregnancy loss at less than 24 weeks' gestation

  5 minutes

• Intrauterine Fetal Demise (IUFD)

  Pregnancy loss at 24 weeks or more, or the delivery of a neonate weighing more than 500 g

  5 minutes

• Maternal death

  Maternal death

  5 minutes

• Low birth weight

  birth weight at less than 2500g

  5 minutes

• Number of participants with Neonatal intensive care unit (NICU) admission

  Number of participants with Neonatal intensive care unit (NICU) admission

  5 minutes

• Percentage of participants with Neonatal intensive care unit (NICU) admission

  Percentage of participants with Neonatal intensive care unit (NICU) admission

  5 minutes

• Number of participants with APGAR score (Activity, Pulse, Grimace, Appearance, Respiration score) at 5 minutes < 7:

  The score minimum is 0 and maximum is 10. Higher score means better outcome.

  5 minutes

• Percentage of participants with APGAR score (Activity, Pulse, Grimace, Appearance, Respiration score) at 5 minutes < 7:

  The score minimum is 0 and maximum is 10. Higher score means better outcome.

  5 minutes

• Number of participants with Respiratory distress at birth

  Number of participants with Respiratory distress at birth

  5 minutes

• Percentage of participants with Respiratory distress at birth

  Percentage of participants with Respiratory distress at birth

  5 minutes

• Neonatal death

  5 minutes

Secondary Outcomes (14)

• Number of participants with Delivery < 32 weeks

  5 minutes

• Percentage of participants with Delivery < 32 weeks

  5 minutes

• Number of participants with Spontaneous delivery < 37 weeks

  5 minutes

• Percentage of participants with Spontaneous delivery < 37 weeks

  5 minutes

• Number of participants with Fetal distress

  5 minutes

Study Arms (3)

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.

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.

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

Other: Data extraction from medical files

Interventions

Data extraction from medical files OTHER

Data extraction from medical files

COVID positive <20 weeks; COVID positive >20 weeks; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (4)

CHU Brugmann

Brussels, 1020, Belgium

Location

Antoine Béclère Hospital

Clamart, 92140, France

Location

Hôpital Louis Mourier

Colombes, 92700, France

Location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Related Publications (7)

• 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.

  PMID: 32730899 BACKGROUND

• 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.

  PMID: 32873575 BACKGROUND

• 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.

  PMID: 32648892 BACKGROUND

• 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.

  PMID: 32633022 BACKGROUND

• 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.

  PMID: 33083779 BACKGROUND

• 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.

  PMID: 32479682 BACKGROUND

• 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.

  PMID: 33039396 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jacques Jani, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gynecology-Obstetrics Department

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: December 8, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

IT (1); FR (2); BE (1)