Covid-19PregWom-CovidNCT04701944
Clinical Study of Pregnant Women With COVID-19
An observational study of Covid-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
A new pandemic, COVID-19, has spread rapidly around the world. She does not spare pregnant women. Little is known about the clinical course of pregnant women infected with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Covid-19
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2020to 21 Apr 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 18 years and older
- Women only
- Adult, Older adult
Study population: Pregnant woman suffering from a confirmed or suspected COVID-19 infection
Who may be able to join
- Adult woman (≥18 years old)
- Pregnant woman
- Suffering from a confirmed or suspected COVID-19 infection
- Patient who has been medically treated at Strasbourg University Hospitals as well as for his newborn baby, between 03/01/2020 and April 30, 2020
- Woman having given, after information, her agreement for the reuse of her data for the purposes of this research
Who cannot join
- Patient who expressed her opposition to participating in the study
- Patient under guardianship or under guardianship
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Gynecology-Obstetrics and Fertility - Strasbourg University Hospitals
Strasbourg, 67091
Philippe DERUELLE, MD, PhD, 33 3 88 12 84 55, philippe.deruelle@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Clinical Study of Pregnant Women With COVID-19: A Retrospective Review of Medical Records at Strasbourg University Hospitals
A new pandemic, COVID-19, has spread rapidly around the world. She does not spare pregnant women. Little is known about the clinical course of pregnant women infected with COVID-19. As of April 1, 2020, six case series and one case report for a total of 61 pregnancies affected by COVID-19, all from the pandemic epicenter in China, except for one state case report -Unis, have been published. These preliminary reports suggest that pregnant women are not more seriously affected than the general population and show a certain gap with what we have observed in the care of pregnant women at HUS. For these reasons, additional information, especially from parts of the world other than China, as the severity of the disease can vary from country to country, is urgently needed to determine whether pregnant women with the disease of COVID-19 will not present with severe pneumonia to COVID-19.
- Conditions
- Covid-19
- Keywords
- COVID-19, COVID-19 Pandemic, Sars-cov-2, Pregnant women
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
A retrospective review of the medical records of pregnant women with COVID-19 at the University Hospitals of Strasbourg
Measured: Files analysed retrospectively from March 01, 2020 to April 30, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start21 Apr 2020
- Primary completion21 Apr 2021 (estimated)
- Study completion21 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe DERUELLE, MD, PhD, Study director, Department of Gynecology-Obstetrics and Fertility - Strasbourg University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701944
- Sponsor's protocol ID
- 7794
- Acronym
- PregWom-Covid
- Status last verified
- Jan 2021
- First submitted
- 7 Jan 2021
- Last updated
- 8 Jan 2021
- 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 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Pregnant Women With COVID-19: A Retrospective Review of Medical Records at Strasbourg University Hospitals
- ClinicalTrials.gov ID
- NCT04701944
- Acronym / sponsor ID
- PregWom-Covid / 7794
- Conditions
- Covid-19
- Keywords
- COVID-19, COVID-19 Pandemic, Sars-cov-2, Pregnant women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 21 Apr 2021 (estimated)
- Study completion
- 21 Apr 2021 (estimated)
- First posted
- 8 Jan 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 new pandemic, COVID-19, has spread rapidly around the world. She does not spare pregnant women. Little is known about the clinical course of pregnant women infected with COVID-19. As of April 1, 2020, six case series and one case report for a total of 61 pregnancies affected by COVID-19, all from the pandemic epicenter in China, except for one state case report -Unis, have been published. These preliminary reports suggest that pregnant women are not more seriously affected than the general population and show a certain gap with what we have observed in the care of pregnant women at HUS. For these reasons, additional information, especially from parts of the world other than China, as the severity of the disease can vary from country to country, is urgently needed to determine whether pregnant women with the disease of COVID-19 will not present with severe pneumonia to COVID-19.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant woman suffering from a confirmed or suspected COVID-19 infection
Key inclusion criteria (5 listed)
- Adult woman (≥18 years old)
- Pregnant woman
- Suffering from a confirmed or suspected COVID-19 infection
- Patient who has been medically treated at Strasbourg University Hospitals as well as for his newborn baby, between 03/01/2020 and April 30, 2020
- Woman having given, after information, her agreement for the reuse of her data for the purposes of this research
Key exclusion criteria (3 listed)
- Patient who expressed her opposition to participating in the study
- Patient under guardianship or under guardianship
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A retrospective review of the medical records of pregnant women with COVID-19 at the University Hospitals of Strasbourg
Time frame: Files analysed retrospectively from March 01, 2020 to April 30, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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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.
Philippe DERUELLE, MD, PhD study director
Department of Gynecology-Obstetrics and Fertility - Strasbourg University Hospitals
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, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Jan 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe DERUELLE, MD, PhD (33 3 88 12 84 55, philippe.deruelle@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A retrospective review of the medical records of pregnant women with COVID-19 at the University Hospitals of Strasbourg (time frame: Files analysed retrospectively from March 01, 2020 to April 30, 2020 will be examined]). 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 8 Jan 2021.