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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04491201
Other study ID # CMDA-SURVEY2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 27, 2020
Est. completion date September 27, 2020

Study information

Verified date July 2020
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 86-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6000
Est. completion date September 27, 2020
Est. primary completion date September 27, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Aged 18 years old

- Belonging to and registered at specific hospital

- Active employment in obstetrics, reproduction, or gynecology

- Signed an approved informed consents

Exclusion Criteria:

- Not meeting all the inclusion criteria

- Not completing the whole questionnaire

Study Design


Intervention

Other:
Customized questionnaire
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.

Locations

Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Six months
Secondary 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. Six months
Secondary 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 Six months
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