Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2020-08-10

Brief Summary

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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.

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Detailed Description

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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

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Pregnancy, Infections in Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1 (Pregnants with COVID-19)

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

Clinical assessment

Intervention Type OTHER

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

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.

Clinical assessment

Intervention Type OTHER

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

Interventions

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Clinical assessment

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes