Pregnancy, Infections inNCT04515108
Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies
An observational study of Pregnancy, Infections in and Covid19, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Infections in, Covid19
- What is being tested?
- Clinical assessment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2020to 10 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Spontaneous pregnancy,
- Singleton pregnancy,
- Clinically diagnosed COVID-19 (SARS-CoV-2 positivity in real time-polymerase chain reaction)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy, Infections in, Covid19
- Being tested
- Clinical assessment
- Keywords
- COVID-19, Pregnancy, Complete blood count, Perinatal outcome, Monocyte/lymphocyte ratio (MLR)
- Medical subject headings
- Pregnancy Complications, Infectious, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentOther
Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Pregnants with COVID-19) | Study group included pregnant women with clinically confirmed COVID-19. Receives: 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. Receives: Other: Clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells).
cell count per mm3.
Measured: first 1 hour of hospitalization.
Secondary outcomes (4)
APGAR score
1st and 5th minute newborn assessment
Measured: 5 minutes
maternal and newborn length
centimeters
Measured: 5 minutes
maternal and newborn weight
kilograms
Measured: 2 minutes
body temperature
Celsius degree
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start10 Mar 2020
- Primary completion5 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, Infections inStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Merve Erol Koç, Ankara City Hospital Bilkent
- Investigators
- Esin Merve Erol Koç, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515108
- Sponsor's protocol ID
- E1-20-672
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data belonging to participant only will be available to any researcher or editorial review board if needed
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.
PubMed 32760752Peng 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.
PubMed 32681559Sun 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.
PubMed 32339487Dashraath 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.
PubMed 32217113
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hematological Parameters and Perinatal Outcomes in COVID-19 Pregnancies and Healthy Pregnancy Cohort
- ClinicalTrials.gov ID
- NCT04515108
- Acronym / sponsor ID
- E1-20-672
- Conditions
- Pregnancy, Infections in, Covid19
- Keywords
- COVID-19, Pregnancy, Complete blood count, Perinatal outcome, Monocyte/lymphocyte ratio (MLR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Pregnants with COVID-19) | – | Other: Clinical assessmentStudy group included pregnant women with clinically confirmed COVID-19. |
| Group 2 (Pregnants without COVID-19) | – | Other: Clinical assessmentControl group consisted of healthy pregnant women in the same number and same gestational week with the Study group. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Spontaneous pregnancy,
- Singleton pregnancy,
- Clinically diagnosed COVID-19 (SARS-CoV-2 positivity in real time-polymerase chain reaction)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessmentPerinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19. | Other | Group 1 (Pregnants with COVID-19), Group 2 (Pregnants without COVID-19) |
Primary outcome
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.
4 secondary outcomes
APGAR score
Time frame: 5 minutes
maternal and newborn length
Time frame: 5 minutes
maternal and newborn weight
Time frame: 2 minutes
body temperature
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Results publication: PubMed 32760752Cheng 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.
- Results publication: PubMed 32681559Peng 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.
- Results publication: PubMed 32339487Sun 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.
- Results publication: PubMed 32217113Dashraath 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.
- Individual participant dataSharing planned: No. Data belonging to participant only will be available to any researcher or editorial review board if needed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esin Merve Erol Koç, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Infections in and Covid19, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete blood count parameters (including the number of lymphocytes, Leukocytes, monocytes, platelets and red blood cells). (time frame: first 1 hour of hospitalization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04515108, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.