Clinical Trials Directory

Trials / Completed

CompletedNCT04515108

Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

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

Status
Completed
Phase
Study type
Observational
Enrollment
108 (actual)
Sponsor
Ankara City Hospital Bilkent · Academic / Other
Sex
Female
Age
18 Years – 42 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERClinical assessmentPerinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.

Timeline

Start date
2020-03-10
Primary completion
2020-08-05
Completion
2020-08-10
First posted
2020-08-17
Last updated
2020-08-17

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04515108. Inclusion in this directory is not an endorsement.