- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03227302
Associations of the Grades of Doctor and Neonatal Outcomes
January 7, 2020 updated by: Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Associations of the Grades of Doctor and Neonatal Outcomes: An Observational Prospective Study
In China, the standardized training system for residents was built last year, and the associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
In China, the grades of doctors and accoucheurs are divided into four levels, and different levels may induce differences of neonatal asphyxia and death.
The standardized training system for residents was built last year,the associations of the grades of doctors and accoucheurs and neonatal asphyxia,neonatal death before and after the training systems need to be assess.
Study Type
Observational
Enrollment (Anticipated)
20000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400042
- Recruiting
- Department of Pediatrics, Daping Hospital, Third Military Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 minute to 3 months (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All neonates with gestational age are from 26 weeks to 42 weeks
Description
Inclusion Criteria:
- Gestational age (GA) is from 26 to 42 weeks
Exclusion Criteria:
- major congenital malformations or complex congenital heart disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
attending obstetrician
the low grade doctor who can do caesarean operation with no pregnant complications.
|
Attending obstetrician can do the caesarean operation without pregnant complications.
|
|
associate chief obstetrician
The middle grade doctor who can do caesarean operation with no or mild or middle pregnant complications.
|
Associate chief Obstetrician can do the caesarean operation without or mild or middle pregnant complications.
|
|
chief obstetrician
the high doctor who can do all caesarean operation without limitations
|
Chief obstetrician can do all caesarean operation without limitations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neonatal asphyxia
Time Frame: within 28 days
|
neonatal asphyxia was defined according to manual of neonatal care
|
within 28 days
|
|
death
Time Frame: within 28 days
|
neonatal death
|
within 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bayley Scales of Infant Development
Time Frame: at 2 months and 2 years old
|
to assess the development using Bayley Scales of Infant Development
|
at 2 months and 2 years old
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Anticipated)
December 30, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
June 30, 2017
First Submitted That Met QC Criteria
July 21, 2017
First Posted (Actual)
July 24, 2017
Study Record Updates
Last Update Posted (Actual)
January 9, 2020
Last Update Submitted That Met QC Criteria
January 7, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- grades of doctor and neonaltal
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.