COVID-19 PandemicsCMDA-SURVEY2NCT04491201
National Survey of the Impact of COVID-19 Pandemics
An observational study of COVID-19 Pandemics and Obstetrics and Gynecology, run by Lei Li at 1 site in China.
Trial summary
COVID-19 pandemics have changed extensively the lives around the world. Although most physicians of obstetrics and gynecology have no critical role in the frontline against COVID-19 pandemics, their work, research and education activities still underwent great changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemics, Obstetrics and Gynecology, Workload
- What is being tested?
- Customized questionnaire
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2020to 27 Sep 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 years and older
- All sexes
- Adult, Older adult
Study population: All physicians of obstetrics and gynecology from the hospitals randomly sampled
Who may be able to join
- Aged 18 years old
- Belonging to and registered at specific hospital
- Active employment in obstetrics, reproduction, or gynecology
- Signed an approved informed consents
Who cannot join
- Not meeting all the inclusion criteria
- Not completing the whole questionnaire
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 8613911988831, lileigh@163.com
About this study
Official title: National Survey of the Impact of COVID-19 Pandemics on Chinese Physicians of Obstetrics and Gynecology
COVID-19 pandemics have changed extensively the lives around the world. Although most physicians of obstetrics and gynecology have no critical role in the frontline against COVID-19 pandemics, their work, research and education activities still underwent great changes. The primary aim of this study is to analyze change of workload during the COVID-19 pandemics in physicians of obstetrics and gynecology in China. A customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously.
A random sampling will be performed in all 32 provinces, municipality or autonomous regions in the mainland of China. It is assumed that acceptable 95% confidence interval is P±4%, and the sample size under the condition of simple random sampling is 600 persons. If the homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting survey, we will achieve a design effect of 2.35 to 3.80. If we choose the design effect of 3, the sample size of every level needs is 1800. Considering 10% population refusing to be surveyed, in all mainland of China, three levels of hospitals will include at least 6000 physicians who accept survey.
- Conditions
- COVID-19 Pandemics, Obstetrics and Gynecology, Workload, Questionnaire, National Survey, China
- Being tested
- Customized questionnaire
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized questionnaireOther
A customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously.
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of workload of physicians during COVID-19 pandemics compared with 2019 year
Reduction or augment in percentage of workload including outpatient clinics, surgeries, counseling and deliveries
Measured: Six months
Secondary outcomes (2)
The changes of education activities during COVID-19 pandemics compared with 2019 year
Reduction or augment in percentage of education activities including lectures, ward rounds and exams.
Measured: Six months
The changes of research activities during COVID-19 pandemics compared with 2019 year
Reduction or augment in percentage of research activities including research protocol advancement, paper composition/submission/publication, and fund application
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start27 Jul 2020
- Primary completion27 Sep 2020 (estimated)
- Study completion27 Sep 2020 (estimated)
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-19 PandemicsStudies 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
- Cross-sectional
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491201
- Sponsor's protocol ID
- CMDA-SURVEY2
- Acronym
- CMDA-SURVEY2
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li L, Cao Y, Fan J, Li T, Lang J, Zhang H, Lv J, Zhu L; Chinese Medical Doctor Association. Impact of COVID-19 Pandemic on the Clinical Activities in Obstetrics and Gynecology: A National Survey in China. Front Med (Lausanne). 2021 Jul 30;8:633477. doi: 10.3389/fmed.2021.633477. eCollection 2021.
PubMed 34395457
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Survey of the Impact of COVID-19 Pandemics on Chinese Physicians of Obstetrics and Gynecology
- ClinicalTrials.gov ID
- NCT04491201
- Acronym / sponsor ID
- CMDA-SURVEY2 / CMDA-SURVEY2
- Conditions
- COVID-19 Pandemics, Obstetrics and Gynecology, Workload, Questionnaire, National Survey, China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 27 Sep 2020 (estimated)
- Study completion
- 27 Sep 2020 (estimated)
- First posted
- 29 Jul 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.
COVID-19 pandemics have changed extensively the lives around the world. Although most physicians of obstetrics and gynecology have no critical role in the frontline against COVID-19 pandemics, their work, research and education activities still underwent great changes. The primary aim of this study is to analyze change of workload during the COVID-19 pandemics in physicians of obstetrics and gynecology in China. A customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously.
A random sampling will be performed in all 32 provinces, municipality or autonomous regions in the mainland of China. It is assumed that acceptable 95% confidence interval is P±4%, and the sample size under the condition of simple random sampling is 600 persons. If the homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting survey, we will achieve a design effect of 2.35 to 3.80. If we choose the design effect of 3, the sample size of every level needs is 1800. Considering 10% population refusing to be surveyed, in all mainland of China, three levels of hospitals will include at least 6000 physicians who accept survey.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All physicians of obstetrics and gynecology from the hospitals randomly sampled
Key inclusion criteria (4 listed)
- Aged 18 years old
- Belonging to and registered at specific hospital
- Active employment in obstetrics, reproduction, or gynecology
- Signed an approved informed consents
Key exclusion criteria (2 listed)
- Not meeting all the inclusion criteria
- Not completing the whole questionnaire
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 |
|---|---|---|
| Customized questionnaireA customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously. | Other | – |
Primary outcome
The changes of workload of physicians during COVID-19 pandemics compared with 2019 year
Time frame: Six months
Reduction or augment in percentage of workload including outpatient clinics, surgeries, counseling and deliveries
2 secondary outcomes
The changes of education activities during COVID-19 pandemics compared with 2019 year
Time frame: Six months
The changes of research activities during COVID-19 pandemics compared with 2019 year
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 34395457Li L, Cao Y, Fan J, Li T, Lang J, Zhang H, Lv J, Zhu L; Chinese Medical Doctor Association. Impact of COVID-19 Pandemic on the Clinical Activities in Obstetrics and Gynecology: A National Survey in China. Front Med (Lausanne). 2021 Jul 30;8:633477. doi: 10.3389/fmed.2021.633477. eCollection 2021.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19 Pandemics
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
Active, not recruiting
Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use
Liver Diseases, Alcohol Use Disorder
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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
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 Pandemics and Obstetrics and Gynecology, run by Lei Li at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 29 Jul 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 China. 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 Lei Li, M.D. (86-139-1198-8831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of workload of physicians during COVID-19 pandemics compared with 2019 year (time frame: Six months). 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 NCT04491201, 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 29 Jul 2020.