NCT03227302

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

5.4 years

First QC Date

June 30, 2017

Last Update Submit

January 7, 2020

Conditions

Standardized Training System for ResidentsNeonatal Outcomes

Outcome Measures

Primary Outcomes (2)

  • neonatal asphyxia

    neonatal asphyxia was defined according to manual of neonatal care

    within 28 days

  • death

    neonatal death

    within 28 days

Secondary Outcomes (1)

  • Bayley Scales of Infant Development

    at 2 months and 2 years old

Study Arms (3)

attending obstetrician

the low grade doctor who can do caesarean operation with no pregnant complications.

Procedure: attending obstetrician

associate chief obstetrician

The middle grade doctor who can do caesarean operation with no or mild or middle pregnant complications.

Procedure: associate obstetrician

chief obstetrician

the high doctor who can do all caesarean operation without limitations

Procedure: chief obstetrician

Interventions

attending obstetricianPROCEDURE

Attending obstetrician can do the caesarean operation without pregnant complications.

attending obstetrician
associate obstetricianPROCEDURE

Associate chief Obstetrician can do the caesarean operation without or mild or middle pregnant complications.

associate chief obstetrician
chief obstetricianPROCEDURE

Chief obstetrician can do all caesarean operation without limitations.

chief obstetrician

Eligibility Criteria

Age1 Minute - 100 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All neonates with gestational age are from 26 weeks to 42 weeks

You may qualify if:

  • Gestational age (GA) is from 26 to 42 weeks

You may not qualify if:

  • major congenital malformations or complex congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Study Officials

  • Shi Yuan, PhD,MD

    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    STUDY DIRECTOR

Central Study Contacts

Ma Juan, MD

CONTACT

13883559467476679422@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 24, 2017

Study Start

August 1, 2017

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations

CN(1)