Clinical Trials/NCT04779749

NCT04779749

Completed

Not Applicable

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

Brugmann University Hospital4 sites in 3 countries10,925 target enrollmentDecember 8, 2020

ConditionsCovid19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Covid19
Sponsor: Brugmann University Hospital
Enrollment: 10925
Locations: 4
Primary Endpoint: Intrauterine Fetal Demise (IUFD)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 8, 2020

End Date

September 1, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Brugmann University Hospital

Responsible Party

Principal Investigator

Jani Jacques

Head of Gynecology-Obstetrics Department

Brugmann University Hospital

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.

Outcomes

Primary Outcomes

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

Number of participants with Cesarean delivery (CD)

Time Frame: 5 minutes

Number of participants with Cesarean delivery (CD)

Percentage of participants with Cesarean delivery (CD)

Time Frame: 5 minutes

Percentage of participants with Cesarean delivery (CD)

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

Time Frame: 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:

Time Frame: 5 minutes

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

Number of participants with Respiratory distress at birth

Time Frame: 5 minutes

Number of participants with Respiratory distress at birth

Percentage of participants with Respiratory distress at birth

Time Frame: 5 minutes

Percentage of participants with Respiratory distress at birth

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)

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.

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.

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

Time Frame: 5 minutes

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

Neonatal death

Time Frame: 5 minutes

Preterm delivery

Time Frame: 5 minutes

Delivery at a gestational age \< 37 weeks

Pulmonary embolism