Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

• ClinicalTrials.gov Identifier: NCT04515108
• Recruitment Status: Completed
• First Posted: August 17, 2020
• Last Update Posted: August 17, 2020
• Sponsor: Ankara City Hospital Bilkent
• 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 ]
  centimeters
• maternal and newborn weight [ Time Frame: 2 minutes ]
  kilograms
• 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.

Condition

• 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 *

• Cheng B, Jiang T, Zhang L, Hu R, Tian J, Jiang Y, Huang B, Li J, Wei M, Yang J, Ren S, Wang G. Clinical Characteristics of Pregnant Women With Coronavirus Disease 2019 in Wuhan, China. Open Forum Infect Dis. 2020 Jul 11;7(8):ofaa294. doi: 10.1093/ofid/ofaa294. eCollection 2020 Aug.
• Peng J, Qi D, Yuan G, Deng X, Mei Y, Feng L, Wang D. Diagnostic value of peripheral hematologic markers for coronavirus disease 2019 (COVID-19): A multicenter, cross-sectional study. J Clin Lab Anal. 2020 Oct;34(10):e23475. doi: 10.1002/jcla.23475. Epub 2020 Jul 17.
• Sun S, Cai X, Wang H, He G, Lin Y, Lu B, Chen C, Pan Y, Hu X. Abnormalities of peripheral blood system in patients with COVID-19 in Wenzhou, China. Clin Chim Acta. 2020 Aug;507:174-180. doi: 10.1016/j.cca.2020.04.024. Epub 2020 Apr 24.
• Dashraath P, Wong JLJ, Lim MXK, Lim LM, Li S, Biswas A, Choolani M, Mattar C, Su LL. Coronavirus disease 2019 (COVID-19) pandemic and pregnancy. Am J Obstet Gynecol. 2020 Jun;222(6):521-531. doi: 10.1016/j.ajog.2020.03.021. Epub 2020 Mar 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2020): 108
• 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.

Sex/Gender

• 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

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

Investigators

• Principal Investigator: Esin Merve Erol Koç, MD; Ankara City Hospital Bilkent

• PRS Account: Ankara City Hospital Bilkent
• Verification Date: August 2020