Comparison of Hematological Parameters and Perinatal Outcomes in COVID-19 Pregnancies and Healthy Pregnancy Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells).
研究概览
简要总结
Complete blood count parameters are routinely evaluated cost-effective markers in diagnosis and clinical follow-up of infectious diseases.There is increasing number of studies to report the course of COVID-19 in pregnancy. The current study aimed to elucidate the changes in hematologic parameters in response to SARS-CoV-2 infection and whether there was an increase in adverse perinatal outcomes such as increased neonatal intensive care unit admission and lower APGAR scores in pregnancies with COVID-19.
详细描述
The objective of this study is to evaluate the relationship between Coronavirus Disease 2019 (COVID-19) in pregnancy and adverse perinatal outcomes. The secondary aim is to analyze the diagnostic value of hematologic parameters in COVID-19 complicated pregnancies.The current study is conducted in a high volume tertiary obstetrics center burdened by COVID-19 pandemics, in Turkey, between March 20 and July 25, 2020. The study included a pregnant women cohort who had been regularly followed up and delivered in our clinics. The cohort was divided into two groups to reveal the impact of COVID-19 on the complete blood count cell indices and unfavorable obstetric and early neonatal outcomes in pregnant women. The clinically confirmed diagnosis of COVID-19 cases were included in Study Group (n=39) the healthy pregnant women without COVID-19 were included in Control Group (n=69). The study achieved a power of 0.89 and 0.98 with a 5% level of significance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Spontaneous pregnancy,
- •Singleton pregnancy,
- •Clinically diagnosed COVID-19 (SARS-CoV-2 positivity in real time-polymerase chain reaction)
排除标准
- •Chronic maternal diseases (rheumatological diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, hypo-hyperthyroidism, congenital hematological disorders),
- •Acute inflammatory conditions (acute pancreatitis, acute appendicitis),
- •Pregnancy complications (gestational diabetes, PPROM, preeclampsia),
- •Multiple pregnancies,
- •Anticoagulant medication.
结局指标
主要结局
complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells).
时间窗: first 1 hour of hospitalization.
cell count per mm3.
次要结局
- maternal and newborn length(5 minutes)
- body temperature(2 minutes)
- APGAR score(5 minutes)
- maternal and newborn weight(2 minutes)
研究者
Esin Merve Erol Koç
Medical Doctor
Ankara City Hospital Bilkent