Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515108
• Other study ID #: E1-20-672
• Status: Completed
• Start date: March 10, 2020
• Est. completion date: August 10, 2020

Study information

• Verified date: August 2020
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 10, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Pregnancy Complications, Infectious
• Pregnancy, Infections in

Intervention

Other:
• Clinical assessment
Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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/ofa — View Citation

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. Review. — View Citation

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 Jul 17:e23475. doi: 10.1002/jcla.23475. [Epub ahea — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells).	cell count per mm3.	first 1 hour of hospitalization.
Secondary	APGAR score	1st and 5th minute newborn assessment	5 minutes
Secondary	maternal and newborn length	centimeters	5 minutes
Secondary	maternal and newborn weight	kilograms	2 minutes
Secondary	body temperature	Celsius degree	2 minutes