Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19 : an International Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,925
- 试验地点
- 4
- 主要终点
- Intrauterine Fetal Demise (IUFD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •All ongoing pregnancies, those with unknown outcomes, those terminated medically or voluntary, as well as patients with spontaneous abortion before the 11th gestational week.
结局指标
主要结局
Intrauterine Fetal Demise (IUFD)
时间窗: 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)
时间窗: 5 minutes
Number of participants with Cesarean delivery (CD)
Percentage of participants with Cesarean delivery (CD)
时间窗: 5 minutes
Percentage of participants with Cesarean delivery (CD)
Percentage of participants with Neonatal intensive care unit (NICU) admission
时间窗: 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:
时间窗: 5 minutes
The score minimum is 0 and maximum is 10. Higher score means better outcome.
Number of participants with Respiratory distress at birth
时间窗: 5 minutes
Number of participants with Respiratory distress at birth
Percentage of participants with Respiratory distress at birth
时间窗: 5 minutes
Percentage of participants with Respiratory distress at birth
Preeclampsia
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 5 minutes
Number of participants with Neonatal intensive care unit (NICU) admission
Neonatal death
时间窗: 5 minutes
Preterm delivery
时间窗: 5 minutes
Delivery at a gestational age \< 37 weeks
Pulmonary embolism
时间窗: 5 minutes
diagnosed by imaging tools such as angio-CT scan of the thorax.
Pregnancy loss at less than 24 weeks' gestation
时间窗: 5 minutes
Low birth weight
时间窗: 5 minutes
birth weight at less than 2500g
Number of participants with APGAR score (Activity, Pulse, Grimace, Appearance, Respiration score) at 5 minutes < 7:
时间窗: 5 minutes
The score minimum is 0 and maximum is 10. Higher score means better outcome.
Deep venous thrombosis
时间窗: 5 minutes
diagnosed by imaging tools such as venous Doppler ultrasound of the lower limbs
Maternal death
时间窗: 5 minutes
Maternal death
次要结局
- Percentage of participants with Spontaneous delivery < 37 weeks(5 minutes)
- Large for gestational age (LGA)(5 minutes)
- Percentage of participants with Unscheduled cesarean delivery(5 minutes)
- Percentage of participants with Intraventricular hemorrhage(5 minutes)
- 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)
- Number of participants with Fetal distress(5 minutes)
- Number of participants with Unscheduled cesarean delivery(5 minutes)
- Postpartum hemorrhage(5 minutes)
- Small for gestational age (SGA)(5 minutes)
- Percentage of participants with Fetal distress(5 minutes)
- Number of participants with Intraventricular hemorrhage(5 minutes)
研究者
Jani Jacques
Head of Gynecology-Obstetrics Department
Brugmann University Hospital