Covid19NCT04883801
Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19
An observational study of Covid19 and Vertical Transmission of Infectious Disease, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
A case-control trial was conducted to test the early postpartum period clinical outcomes of newborns born to pregnant women with and without COVID-19. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Vertical Transmission of Infectious Disease, Neonatal Infection
- What is being tested?
- Reviewed clinical records and laboratory results
- How many people
- 202 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2020to 5 May 2021
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Newborns born to pregnant women with and without COVID-19 at Denizli State Hospital between March 11, 2020 - March 11, 2021.
Who may be able to join
- Pregnant women on labor or preterm labor. Pregnant women who underwent programmed or emergence cesarean
Who cannot join
- Those who were transferred to another hospital without or within a short period of delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Early Postnatal Clinical Outcomes of Newborns Born to Pregnant Women With COVID-19: A Case-control Study
A case-control trial was conducted to test the early postpartum period clinical outcomes of newborns born to pregnant women with and without COVID-19.
- Conditions
- Covid19, Vertical Transmission of Infectious Disease, Neonatal Infection, Pregnancy Related
- Being tested
- Reviewed clinical records and laboratory results
- Keywords
- Childbirth, COVID-19, Neonatal outcomes, Newborn, Pregnant women, Vertical transmission
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reviewed clinical records and laboratory resultsDiagnostic test
Retrospectively reviewed clinical records and laboratory results
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 case group | Newborns born to pregnant women diagnosed with COVID-19 during hospitalization for delivery Receives: Diagnostic Test: Reviewed clinical records and laboratory results | |
| Control group | Newborns born to pregnant women who were not diagnosed with COVID-19 in their medical history and hospitalization for delivery Receives: Diagnostic Test: Reviewed clinical records and laboratory results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical transmission
Determine the prevalence of COVID-19 in newborns born to pregnant women with COVID-19 with PCR from a nasopharyngeal swab.
Measured: 48 hours after birth
Neonatal birth outcomes
Determine the neonatal outcomes of the newborn specifying the birth week of the newborn, delivery type (vaginal or cesarean), birth weight (g), APGAR scores in the first and fifth minutes after birth.
Measured: At birth
Neonatal postnatal outcomes
Determine the prevalence of neonatal postnatal outcomes of the newborn specifying the respiratory system illness, intensive care need, oxygen need, neonatal mortality, general health status, and breastfeeding status.
Measured: Within 48 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start11 Mar 2020
- Primary completion11 Mar 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Akyıldız, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883801
- Sponsor's protocol ID
- Newborns outcomes
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Postnatal Clinical Outcomes of Newborns Born to Pregnant Women With COVID-19: A Case-control Study
- ClinicalTrials.gov ID
- NCT04883801
- Acronym / sponsor ID
- Newborns outcomes
- Conditions
- Covid19, Vertical Transmission of Infectious Disease, Neonatal Infection, Pregnancy Related
- Keywords
- Childbirth, COVID-19, Neonatal outcomes, Newborn, Pregnant women, Vertical transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 12 May 2021 (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.
A case-control trial was conducted to test the early postpartum period clinical outcomes of newborns born to pregnant women with and without COVID-19.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 case group | – | Diagnostic Test: Reviewed clinical records and laboratory resultsNewborns born to pregnant women diagnosed with COVID-19 during hospitalization for delivery |
| Control group | – | Diagnostic Test: Reviewed clinical records and laboratory resultsNewborns born to pregnant women who were not diagnosed with COVID-19 in their medical history and hospitalization for delivery |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Newborns born to pregnant women with and without COVID-19 at Denizli State Hospital between March 11, 2020 - March 11, 2021.
Key inclusion criteria (1 listed)
- Pregnant women on labor or preterm labor. Pregnant women who underwent programmed or emergence cesarean
Key exclusion criteria (1 listed)
- Those who were transferred to another hospital without or within a short period of delivery
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 |
|---|---|---|
| Reviewed clinical records and laboratory resultsRetrospectively reviewed clinical records and laboratory results | Diagnostic test | COVID-19 case group, Control group |
Primary outcome
Vertical transmission
Time frame: 48 hours after birth
Determine the prevalence of COVID-19 in newborns born to pregnant women with COVID-19 with PCR from a nasopharyngeal swab.
Neonatal birth outcomes
Time frame: At birth
Determine the neonatal outcomes of the newborn specifying the birth week of the newborn, delivery type (vaginal or cesarean), birth weight (g), APGAR scores in the first and fifth minutes after birth.
Neonatal postnatal outcomes
Time frame: Within 48 hours after birth
Determine the prevalence of neonatal postnatal outcomes of the newborn specifying the respiratory system illness, intensive care need, oxygen need, neonatal mortality, general health status, and breastfeeding status.
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 12 May 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and Vertical Transmission of Infectious Disease, run by Kahramanmaras Sutcu Imam University 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 1 inclusion and 1 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 12 May 2021. 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?
Vertical transmission (time frame: 48 hours after birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2021.