- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515108
Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies
August 14, 2020 updated by: Esin Merve Erol Koç, Ankara City Hospital Bilkent
Comparison of Hematological Parameters and Perinatal Outcomes in COVID-19 Pregnancies and Healthy Pregnancy Cohort
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
108
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06100
- Ankara City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1 (Pregnants with COVID-19)
Study group included pregnant women with clinically confirmed COVID-19.
|
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.
|
Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
first 1 hour of hospitalization.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
APGAR score
Time Frame: 5 minutes
|
1st and 5th minute newborn assessment
|
5 minutes
|
maternal and newborn length
Time Frame: 5 minutes
|
centimeters
|
5 minutes
|
maternal and newborn weight
Time Frame: 2 minutes
|
kilograms
|
2 minutes
|
body temperature
Time Frame: 2 minutes
|
Celsius degree
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Esin Merve Erol Koç, MD, Ankara City Hospital Bilkent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2020
Primary Completion (Actual)
August 5, 2020
Study Completion (Actual)
August 10, 2020
Study Registration Dates
First Submitted
August 14, 2020
First Submitted That Met QC Criteria
August 14, 2020
First Posted (Actual)
August 17, 2020
Study Record Updates
Last Update Posted (Actual)
August 17, 2020
Last Update Submitted That Met QC Criteria
August 14, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E1-20-672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data belonging to participant only will be available to any researcher or editorial review board if needed
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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