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

Study Overview
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Other: Data extraction from medical files


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID positive <20 weeks<br>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<br>* Data extraction from medical files<br>|
| COVID positive >20 weeks<br>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<br>* Data extraction from medical files<br>|
| Control<br>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<br>* Data extraction from medical files<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | referred to bradycardia, recurrent late or variable deceleration on antepartum or intrapartum cardiotocogram. | 5 minutes | 
| Percentage of participants with Fetal distress | referred to bradycardia, recurrent late or variable deceleration on antepartum or intrapartum cardiotocogram. | 5 minutes | 
| Number of participants with Unscheduled cesarean delivery |  | 5 minutes | 
| Percentage of participants with Unscheduled cesarean delivery |  | 5 minutes | 
| Postpartum hemorrhage | defined as the estimated blood loss of > 500 mL | 5 minutes | 
| Number of participants with Intraventricular hemorrhage |  | 5 minutes | 
| Percentage of participants with Intraventricular hemorrhage |  | 5 minutes | 
| Umbilical cord pH |  | 5 minutes | 
| Small for gestational age (SGA) | it refers to an estimated fetal weight of less than the 10th percentile | 5 minutes | 
| Large for gestational age (LGA) | it refers to an estimated fetal weight of more than the 95th percentile | 5 minutes |