Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies

Completed

• Conditions: Pregnancy, Infections in; Covid19
• Interventions: Other: Clinical assessment

• Registration Number: NCT04515108
• Lead Sponsor: Ankara City Hospital Bilkent

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 Timeline

• Study Start: 2020-03-10
• Status Verified: 2020-08
• Primary Completion: 2020-08-05
• Study Completion: 2020-08-10
• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-08-14
• Last Update Submitted: 2020-08-14
• Study First Posted: 2020-08-17
• Last Update Posted: 2020-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 (Pregnants with COVID-19)	Clinical assessment	Study group included pregnant women with clinically confirmed COVID-19.
Group 2 (Pregnants without COVID-19)	Clinical assessment	Control group consisted of healthy pregnant women in the same number and same gestational week with the Study group.

Primary Outcome Measures

Name	Time	Method
complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells).	first 1 hour of hospitalization.	cell count per mm3.

Secondary Outcome Measures

Name	Time	Method
maternal and newborn length	5 minutes	centimeters
body temperature	2 minutes	Celsius degree
APGAR score	5 minutes	1st and 5th minute newborn assessment
maternal and newborn weight	2 minutes	kilograms

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey