Covid-19AMPCOVID-19NCT04415359
Evaluation of the Evolution of Pregnancies in the First Trimester Following MAR Management During a COVD-19 Pandemic Period
An observational study of Covid-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Because of the physiological changes inherent in pregnancy, pregnant women with lower respiratory tract infections often have more worrisome outcomes compared to non-pregnant individuals, including a higher rate of hospital and intensive care unit admissions. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Covid-19
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 31 Dec 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 43 years
- Women only
- Adult
Study population: Patient included in MAR protocol aged between 18 and 43 years of age who has already signed a consent to management
Who may be able to join
- Patient included in a Medically Assisted Procreation (MAR) protocol aged between 18 and 43 years of age
- Patient who has already signed a consent to management
Who cannot join
- Patient who expressed opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Service Clinico biologique d'Assistance Médicale à La Procréation
Strasbourg, 67091
About this study
Official title: Evaluation of the Evolution of Pregnancies in the First Trimester Following a Medically Assisted Procreation (MAR) Management During a COVD-19 Pandemic Period
Because of the physiological changes inherent in pregnancy, pregnant women with lower respiratory tract infections often have more worrisome outcomes compared to non-pregnant individuals, including a higher rate of hospital and intensive care unit admissions.
- Conditions
- Covid-19
- Keywords
- COVID-19, SARS-CoV-2, ARDS, ICU, Pregnant women, Pregnancy, Fetus, Middle East Respiratory Syndrome, MERS, Maternal respiratory impairment, Medical Assisted Procreation, MAR, Frozen embryos
- Medical subject headings
- COVID-19, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the evolution of pregnancies in the first trimester following MAR management during a COVD-19 pandemic period
Measured: 12th week of Amenorrhea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Aug 2020
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
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.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415359
- Sponsor's protocol ID
- 7789
- Acronym
- AMPCOVID-19
- Status last verified
- May 2020
- First submitted
- 29 May 2020
- Last updated
- 1 Apr 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Evolution of Pregnancies in the First Trimester Following a Medically Assisted Procreation (MAR) Management During a COVD-19 Pandemic Period
- ClinicalTrials.gov ID
- NCT04415359
- Acronym / sponsor ID
- AMPCOVID-19 / 7789
- Conditions
- Covid-19
- Keywords
- COVID-19, SARS-CoV-2, ARDS, ICU, Pregnant women, Pregnancy, Fetus, Middle East Respiratory Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 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.
Because of the physiological changes inherent in pregnancy, pregnant women with lower respiratory tract infections often have more worrisome outcomes compared to non-pregnant individuals, including a higher rate of hospital and intensive care unit admissions.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patient included in MAR protocol aged between 18 and 43 years of age who has already signed a consent to management
Key inclusion criteria (2 listed)
- Patient included in a Medically Assisted Procreation (MAR) protocol aged between 18 and 43 years of age
- Patient who has already signed a consent to management
Key exclusion criteria (1 listed)
- Patient who expressed opposition to participating in the study
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
Study of the evolution of pregnancies in the first trimester following MAR management during a COVD-19 pandemic period
Time frame: 12th week of Amenorrhea
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 Apr 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.
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, 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 2 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 Apr 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?
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?
Study of the evolution of pregnancies in the first trimester following MAR management during a COVD-19 pandemic period (time frame: 12th week of Amenorrhea). 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 1 Apr 2021.