COVID-19NCT04410939
COVID-19 PCR Test Results in Asymptomatic Pregnants
An observational study of COVID-19 and Asymptomatic Pregnant, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
In order to prevent contamination from the pregnant women hospitalized in this clinic, the RT-PCR test is performed from the oropharyngeal and nasal swab sample taken before hospitalization. In addition, the same test is done before each operation and before the operation. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Asymptomatic Pregnant
- What is being tested?
- Reverse transcription polymerase chain reaction
- How many people
- 179 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2020to 21 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant patients who apply to Istanbul Medipol University Hospital
Who may be able to join
- Asymptomatic pregnant women who will give birth in this clinic, dilatation and curettage due to missed abortion, cerclage due to cervical insufficiency, medical evacuation due to fetal anomaly, and routine PCR test taken for service for some treatments.
Who cannot join
- Having any COVID-19 infection symptoms (fever, cough, weakness, shortness of breath, sore throat, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 PCR Test Results in Asymptomatic Pregnants Admitted for Birth and Other Interventions in Our Clinic
In order to prevent contamination from the pregnant women hospitalized in this clinic, the RT-PCR test is performed from the oropharyngeal and nasal swab sample taken before hospitalization. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant women who undergo intervention.
- Conditions
- COVID-19, Asymptomatic Pregnant
- Being tested
- Reverse transcription polymerase chain reaction
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse transcription polymerase chain reactionDiagnostic test
PCR test is performed from the oropharyngeal and nasal swab samples taken before admission to each pregnant to prevent contamination from the pregnant women hospitalized in this clinic. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant and undergoing pregnant women.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of positive COVID-19 cases in asymptomatic pregnant women
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start10 Apr 2020
- Primary completion20 May 2020
- Study completion21 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410939
- Sponsor's protocol ID
- Gpolat1
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available.
PubMed 32283004
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 PCR Test Results in Asymptomatic Pregnants Admitted for Birth and Other Interventions in Our Clinic
- ClinicalTrials.gov ID
- NCT04410939
- Acronym / sponsor ID
- Gpolat1
- Conditions
- COVID-19, Asymptomatic Pregnant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 1 Jun 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.
In order to prevent contamination from the pregnant women hospitalized in this clinic, the RT-PCR test is performed from the oropharyngeal and nasal swab sample taken before hospitalization. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant women who undergo intervention.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant patients who apply to Istanbul Medipol University Hospital
Key inclusion criteria (1 listed)
- Asymptomatic pregnant women who will give birth in this clinic, dilatation and curettage due to missed abortion, cerclage due to cervical insufficiency, medical evacuation due to fetal anomaly, and routine PCR test taken for service for some treatments.
Key exclusion criteria (1 listed)
- Having any COVID-19 infection symptoms (fever, cough, weakness, shortness of breath, sore throat, etc.)
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 |
|---|---|---|
| Reverse transcription polymerase chain reactionPCR test is performed from the oropharyngeal and nasal swab samples taken before admission to each pregnant to prevent contamination from the pregnant women hospitalized in this clinic. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant and undergoing pregnant women. | Diagnostic test | – |
Primary outcome
Rate of positive COVID-19 cases in asymptomatic pregnant women
Time frame: 1 day
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 1 Jun 2020.
- Background: PubMed 32283004Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available.
- Individual participant dataSharing planned: Yes
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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 COVID-19 and Asymptomatic Pregnant, run by Istanbul Medipol University 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 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 1 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?
Rate of positive COVID-19 cases in asymptomatic pregnant women (time frame: 1 day). 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 NCT04410939, which also lists 1 linked publication.
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 1 Jun 2020.