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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04515108
Enrollment
108
Registered
2020-08-17
Start date
2020-03-10
Completion date
2020-08-10
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Pregnancy, Infections in

Keywords

COVID-19, Pregnancy, Complete blood count, Perinatal outcome, Monocyte/lymphocyte ratio (MLR)

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.

Interventions

OTHERClinical assessment

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

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
APGAR score5 minutes1st and 5th minute newborn assessment
maternal and newborn length5 minutescentimeters
maternal and newborn weight2 minuteskilograms
body temperature2 minutesCelsius degree

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026