Covid19NCT04337320
Maternal And Neonatal Outcome of Pregnant Patients With COVID-19 in Istanbul, Turkey: A Single-Center, Retrospective, Descriptive Study
An observational study of Covid19 and Maternal-Fetal Relations, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers Read more about this study
- Who is it for?
- Ages 1 minute to 15 minutesHealthy volunteers can take part
- Conditions the study is for
- Covid19, Maternal-Fetal Relations
- What is being tested?
- newborns from covid 19 positive mothers
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 30 May 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 1 minute to 15 minutes
- All sexes
- Healthy volunteers accepted
- Child
Study population: Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers
Who may be able to join
- from covid 19 positive mothers
- newborn mothers had not other condition or illness
Who cannot join
- from covid 19 negative mothers
- childs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal And Neonatal Outcome of Pregnant Patients With COVID-19
Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers
- Conditions
- Covid19, Maternal-Fetal Relations
- Being tested
- newborns from covid 19 positive mothers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
newborns from covid 19 positive mothersOther
Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of apgar status of newborns from covid 19 positive mothers
The Apgar score is looked after at 1 and 5 minutes after birth, if the baby's Apgar score is lower than 7, it is repeated every 5 minutes until 20 minutes. Parameters examined in Apgar score Muscle tone, Heart rate, Reflexes, Skin color, Respiration.
In the Apgar score, the baby is evaluated and scores are collected.
7 - 10: The baby is normal.
4 - 6: They usually recover with respiratory support.
0 - 3: Urgent intervention and resuscitation is needed.
The low Apgar score in the 1st minute usually returns to normal in the 5th minute with support. Despite the intervention, the Apgar scores of 5 and less at 5 and 10 minutes are associated with an increased risk of mortality and cerebral palsy.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start15 Mar 2020
- Primary completion25 May 2020
- Study completion30 May 2020
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seda Yilmaz Semerci
- Responsible party
- Principal investigator, Merve Aldikactioglu Talmac, MD, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337320
- Sponsor's protocol ID
- covid19pregnancynewborn
- Status last verified
- Jun 2020
- First submitted
- 5 Apr 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal And Neonatal Outcome of Pregnant Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04337320
- Acronym / sponsor ID
- covid19pregnancynewborn
- Conditions
- Covid19, Maternal-Fetal Relations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Seda Yilmaz Semerci
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 7 Apr 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.
Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 minute to 15 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers
Key inclusion criteria (2 listed)
- from covid 19 positive mothers
- newborn mothers had not other condition or illness
Key exclusion criteria (2 listed)
- from covid 19 negative mothers
- childs
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 |
|---|---|---|
| newborns from covid 19 positive mothersEvaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers | Other | – |
Primary outcome
Evaluation of apgar status of newborns from covid 19 positive mothers
Time frame: 2 months
The Apgar score is looked after at 1 and 5 minutes after birth, if the baby's Apgar score is lower than 7, it is repeated every 5 minutes until 20 minutes. Parameters examined in Apgar score Muscle tone, Heart rate, Reflexes, Skin color, Respiration. In the Apgar score, the baby is evaluated and scores are collected. 7 - 10: The baby is normal. 4 - 6: They usually recover with respiratory support. 0 - 3: Urgent intervention and resuscitation is needed. The low Apgar score in the 1st minute usually returns to normal in the 5th minute with support. Despite the intervention, the Apgar scores of 5 and less at 5 and 10 minutes are associated with an increased risk of mortality and cerebral palsy.
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 11 Jun 2020.
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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 Maternal-Fetal Relations, run by Kanuni Sultan Suleyman Training and Research Hospital 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 2 inclusion and 2 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 11 Jun 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?
Evaluation of apgar status of newborns from covid 19 positive mothers (time frame: 2 months). 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 11 Jun 2020.