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Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04515108
Recruitment Status : Completed
First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Esin Merve Erol Koç, Ankara City Hospital Bilkent

Study Description
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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.

Condition or disease Intervention/treatment
Pregnancy, Infections in Covid19 Other: Clinical assessment

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.
Study Design
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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Hematological Parameters and Perinatal Outcomes in COVID-19 Pregnancies and Healthy Pregnancy Cohort
Actual Study Start Date : March 10, 2020
Actual Primary Completion Date : August 5, 2020
Actual Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1 (Pregnants with COVID-19)
Study group included pregnant women with clinically confirmed COVID-19.
 Other: Clinical assessment
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.
 Other: Clinical assessment
Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The current study included 39 pregnant women with clinical diagnosis of COVID-19 on the obstetric isolation unite and 69 pregnant women without COVID-19.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515108


Locations
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Turkey
Ankara City Hospital
Ankara, Turkey, 06100
Sponsors and Collaborators
Ankara City Hospital Bilkent
Investigators
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Principal Investigator: Esin Merve Erol Koç, MD Ankara City Hospital Bilkent
More Information
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Publications of Results:

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Responsible Party: Esin Merve Erol Koç, Medical Doctor, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier: NCT04515108    
Other Study ID Numbers: E1-20-672
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data belonging to participant only will be available to any researcher or editorial review board if needed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Esin Merve Erol Koç, Ankara City Hospital Bilkent:
COVID-19
Pregnancy
Complete blood count
Perinatal outcome
Monocyte/lymphocyte ratio (MLR)
Additional relevant MeSH terms:
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COVID-19
Pregnancy Complications, Infectious
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pregnancy Complications