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Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

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ClinicalTrials.gov Identifier: NCT04515108
Recruitment Status : Completed
First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Information provided by (Responsible Party):
Esin Merve Erol Koç, Ankara City Hospital Bilkent

Tracking Information
First Submitted Date August 14, 2020
First Posted Date August 17, 2020
Last Update Posted Date August 17, 2020
Actual Study Start Date March 10, 2020
Actual Primary Completion Date August 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 14, 2020)
  • APGAR score [ Time Frame: 5 minutes ]
    1st and 5th minute newborn assessment
  • maternal and newborn length [ Time Frame: 5 minutes ]
  • maternal and newborn weight [ Time Frame: 2 minutes ]
  • body temperature [ Time Frame: 2 minutes ]
    Celsius degree
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies
Official Title Comparison of Hematological Parameters and Perinatal Outcomes in COVID-19 Pregnancies and Healthy Pregnancy Cohort
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
  • Pregnancy, Infections in
  • Covid19
Intervention Other: Clinical assessment
Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.
Study Groups/Cohorts
  • Group 1 (Pregnants with COVID-19)
    Study group included pregnant women with clinically confirmed COVID-19.
    Intervention: Other: Clinical assessment
  • 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.
    Intervention: Other: Clinical assessment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 14, 2020)
Original Actual Enrollment Same as current
Actual Study Completion Date August 10, 2020
Actual Primary Completion Date August 5, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sexes Eligible for Study: Female
Ages 18 Years to 42 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
Administrative Information
NCT Number NCT04515108
Other Study ID Numbers E1-20-672
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Current Responsible Party Esin Merve Erol Koç, Ankara City Hospital Bilkent
Original Responsible Party Same as current
Current Study Sponsor Ankara City Hospital Bilkent
Original Study Sponsor Same as current
Collaborators Not Provided
Principal Investigator: Esin Merve Erol Koç, MD Ankara City Hospital Bilkent
PRS Account Ankara City Hospital Bilkent
Verification Date August 2020