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Completed

NCT Number: NCT04779749

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Brugmann, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data extraction from medical files

Other

Data extraction from medical files

Primary outcomes

  1. Preterm delivery

    Time frame: 5 minutes

    Delivery at a gestational age < 37 weeks

  2. Preeclampsia

    Time frame: 5 minutes

    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)

  3. Eclampsia

    Time frame: 5 minutes

    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.

  4. Hemolysis Elevated Liver enzymes Low Platelets Syndrome (HELLP)

    Time frame: 5 minutes

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

  5. Number of participants with Cesarean delivery (CD)

    Time frame: 5 minutes

    Number of participants with Cesarean delivery (CD)

  6. Percentage of participants with Cesarean delivery (CD)

    Time frame: 5 minutes

    Percentage of participants with Cesarean delivery (CD)

  7. Deep venous thrombosis

    Time frame: 5 minutes

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

  8. Pulmonary embolism

    Time frame: 5 minutes

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

  9. Pregnancy loss at less than 24 weeks' gestation

    Time frame: 5 minutes

  10. Intrauterine Fetal Demise (IUFD)

    Time frame: 5 minutes

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

  11. Maternal death

    Time frame: 5 minutes

    Maternal death

  12. Low birth weight

    Time frame: 5 minutes

    birth weight at less than 2500g

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

    Time frame: 5 minutes

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

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

    Time frame: 5 minutes

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

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

    Time frame: 5 minutes

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

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

    Time frame: 5 minutes

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

  17. Number of participants with Respiratory distress at birth

    Time frame: 5 minutes

    Number of participants with Respiratory distress at birth

  18. Percentage of participants with Respiratory distress at birth

    Time frame: 5 minutes

    Percentage of participants with Respiratory distress at birth

  19. Neonatal death

    Time frame: 5 minutes

Secondary outcomes

  1. Number of participants with Delivery < 32 weeks

    Time frame: 5 minutes

  2. Percentage of participants with Delivery < 32 weeks

    Time frame: 5 minutes

  3. Number of participants with Spontaneous delivery < 37 weeks

    Time frame: 5 minutes

  4. Percentage of participants with Spontaneous delivery < 37 weeks

    Time frame: 5 minutes

  5. Number of participants with Fetal distress

    Time frame: 5 minutes

    referred to bradycardia, recurrent late or variable deceleration on antepartum or intrapartum cardiotocogram.

  6. Percentage of participants with Fetal distress

    Time frame: 5 minutes

    referred to bradycardia, recurrent late or variable deceleration on antepartum or intrapartum cardiotocogram.

  7. Number of participants with Unscheduled cesarean delivery

    Time frame: 5 minutes

  8. Percentage of participants with Unscheduled cesarean delivery

    Time frame: 5 minutes

  9. Postpartum hemorrhage

    Time frame: 5 minutes

    defined as the estimated blood loss of > 500 mL

  10. Number of participants with Intraventricular hemorrhage

    Time frame: 5 minutes

  11. Percentage of participants with Intraventricular hemorrhage

    Time frame: 5 minutes

  12. Umbilical cord pH

    Time frame: 5 minutes

  13. Small for gestational age (SGA)

    Time frame: 5 minutes

    it refers to an estimated fetal weight of less than the 10th percentile

  14. Large for gestational age (LGA)

    Time frame: 5 minutes

    it refers to an estimated fetal weight of more than the 95th percentile

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19 : an International Case-control Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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