Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Comparison of Hematological Parameters and Perinatal Outcomes in COVID-19 Pregnancies and Healthy Pregnancy Cohort

Conditions
-----------------
Pregnancy, Infections in, Covid19

Intervention / Treatment
-----------------
* Other: Clinical assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spontaneous pregnancy, Singleton pregnancy, Clinically diagnosed COVID-19 (SARS-CoV-2 positivity in real time-polymerase chain reaction) Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 (Pregnants with COVID-19)<br>Study group included pregnant women with clinically confirmed COVID-19. | Other: Clinical assessment<br>* Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.<br>|
| Group 2 (Pregnants without COVID-19)<br>Control group consisted of healthy pregnant women in the same number and same gestational week with the Study group. | Other: Clinical assessment<br>* Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells). | cell count per mm3. | first 1 hour of hospitalization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APGAR score | 1st and 5th minute newborn assessment | 5 minutes | 
| maternal and newborn length | centimeters | 5 minutes | 
| maternal and newborn weight | kilograms | 2 minutes | 
| body temperature | Celsius degree | 2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Pregnancy, Complete blood count, Perinatal outcome, Monocyte/lymphocyte ratio (MLR)