Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

Ankara City Hospital

Status: Completed

Conditions: Covid19; Pregnancy, Infections in

Treatments: Other: Clinical assessment

Study type: Observational

Funder types: Other

Identifiers

NCT04515108

E1-20-672

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

108 participants in 2 patient groups

Group 1 (Pregnants with COVID-19)

Description:

Study group included pregnant women with clinically confirmed COVID-19.

Treatment:

Other: Clinical assessment

Group 2 (Pregnants without COVID-19)

Description:

Control group consisted of healthy pregnant women in the same number and same gestational week with the Study group.

Treatment:

Other: Clinical assessment