Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19
- Conditions
- Covid19
- Interventions
- Other: Data extraction from medical files
- Registration Number
- NCT04779749
- Lead Sponsor
- Brugmann University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10925
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.
All ongoing pregnancies, those with unknown outcomes, those terminated medically or voluntary, as well as patients with spontaneous abortion before the 11th gestational week.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID positive >20 weeks Data extraction from medical files 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. Control Data extraction from medical files Patients not infected by SARS-CoV2 during pregnancy during the period starting on February 1st 2020 and ending on November 30th 2020 COVID positive <20 weeks Data extraction from medical files 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.
- Primary Outcome Measures
Name Time Method Intrauterine Fetal Demise (IUFD) 5 minutes Pregnancy loss at 24 weeks or more, or the delivery of a neonate weighing more than 500 g
Number of participants with Cesarean delivery (CD) 5 minutes Number of participants with Cesarean delivery (CD)
Percentage of participants with Cesarean delivery (CD) 5 minutes Percentage of participants with Cesarean delivery (CD)
Percentage 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 APGAR score (Activity, Pulse, Grimace, Appearance, Respiration score) at 5 minutes < 7: 5 minutes The score minimum is 0 and maximum is 10. Higher score means better outcome.
Number of participants with Respiratory distress at birth 5 minutes Number of participants with Respiratory distress at birth
Percentage of participants with Respiratory distress at birth 5 minutes Percentage of participants with Respiratory distress at birth
Preeclampsia 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)Eclampsia 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.
Hemolysis Elevated Liver enzymes Low Platelets Syndrome (HELLP) 5 minutes HELLP syndrome is considered to be a serious complication or variant of preeclampsia in pregnant women.
Number of participants with Neonatal intensive care unit (NICU) admission 5 minutes Number of participants with Neonatal intensive care unit (NICU) admission
Neonatal death 5 minutes Pulmonary embolism 5 minutes diagnosed by imaging tools such as angio-CT scan of the thorax.
Pregnancy loss at less than 24 weeks' gestation 5 minutes Low birth weight 5 minutes birth weight at less than 2500g
Number of participants with APGAR score (Activity, Pulse, Grimace, Appearance, Respiration score) at 5 minutes < 7: 5 minutes The score minimum is 0 and maximum is 10. Higher score means better outcome.
Deep venous thrombosis 5 minutes diagnosed by imaging tools such as venous Doppler ultrasound of the lower limbs
Maternal death 5 minutes Maternal death
Preterm delivery 5 minutes Delivery at a gestational age \< 37 weeks
- Secondary Outcome Measures
Name Time Method Percentage of participants with Unscheduled cesarean delivery 5 minutes Percentage of participants with Intraventricular hemorrhage 5 minutes Large for gestational age (LGA) 5 minutes it refers to an estimated fetal weight of more than the 95th percentile
Percentage of participants with Delivery < 32 weeks 5 minutes Number of participants with Spontaneous delivery < 37 weeks 5 minutes Umbilical cord pH 5 minutes Number of participants with Delivery < 32 weeks 5 minutes Percentage of participants with Spontaneous delivery < 37 weeks 5 minutes Number of participants with Fetal distress 5 minutes referred to bradycardia, recurrent late or variable deceleration on antepartum or intrapartum cardiotocogram.
Number of participants with Unscheduled cesarean delivery 5 minutes Postpartum hemorrhage 5 minutes defined as the estimated blood loss of \> 500 mL
Small for gestational age (SGA) 5 minutes it refers to an estimated fetal weight of less than the 10th percentile
Percentage of participants with Fetal distress 5 minutes referred to bradycardia, recurrent late or variable deceleration on antepartum or intrapartum cardiotocogram.
Number of participants with Intraventricular hemorrhage 5 minutes
Trial Locations
- Locations (4)
Antoine Béclère Hospital
🇫🇷Clamart, France
Hôpital Louis Mourier
🇫🇷Colombes, France
CHU Brugmann
🇧🇪Brussels, Belgium
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy