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NCT Number: NCT04515108

Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Assessment

Other

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

Primary outcomes

  1. complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells).

    Time frame: first 1 hour of hospitalization.

    cell count per mm3.

Secondary outcomes

  1. APGAR score

    Time frame: 5 minutes

    1st and 5th minute newborn assessment

  2. maternal and newborn length

    Time frame: 5 minutes

    centimeters

  3. maternal and newborn weight

    Time frame: 2 minutes

    kilograms

  4. body temperature

    Time frame: 2 minutes

    Celsius degree

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2020
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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