Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Group 1 (Pregnants with COVID-19) Study group included pregnant women with clinically confirmed COVID-19. |
Other: Clinical assessment
Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.
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Group 2 (Pregnants without COVID-19) Control group consisted of healthy pregnant women in the same number and same gestational week with the Study group. |
Other: Clinical assessment
Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.
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Outcome Measures
Primary Outcome Measures
- complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells). [first 1 hour of hospitalization.]
cell count per mm3.
Secondary Outcome Measures
- APGAR score [5 minutes]
1st and 5th minute newborn assessment
- maternal and newborn length [5 minutes]
centimeters
- maternal and newborn weight [2 minutes]
kilograms
- body temperature [2 minutes]
Celsius degree
Eligibility Criteria
Criteria
Inclusion Criteria:
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Spontaneous pregnancy,
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Singleton pregnancy,
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Clinically diagnosed COVID-19 (SARS-CoV-2 positivity in real time-polymerase chain reaction)
Exclusion Criteria:
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Chronic maternal diseases (rheumatological diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, hypo-hyperthyroidism, congenital hematological disorders),
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Acute inflammatory conditions (acute pancreatitis, acute appendicitis),
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Pregnancy complications (gestational diabetes, PPROM, preeclampsia),
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Multiple pregnancies,
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Anticoagulant medication.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ankara City Hospital | Ankara | Turkey | 06100 |
Sponsors and Collaborators
- Ankara City Hospital Bilkent
Investigators
- Principal Investigator: Esin Merve Erol Koç, MD, Ankara City Hospital Bilkent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E1-20-672