NCT03391648

Brief Summary

Recruit the parturients who underwent cesarean delivery at Far Eastern MemorialHospital during 2012-2016. After reviewing medical record related to the pregnancy, demographic data, prenatal exam, laboratory data, indication for cesarean section, perioperative events, etc. will be recorded. Analysis will be focused on incidence, temporal trend, and risk factors of anesthesia-related adverse events and obstetric complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

December 30, 2017

Last Update Submit

February 12, 2019

Conditions

Anesthesia; Adverse Effect, in Labor and Delivery

Outcome Measures

Primary Outcomes (1)

  • Incidence of anesthesia-related adverse events

    Within 42 days after delivery

Study Arms (1)

Cesarean

Other: Observation

Interventions

ObservationOTHER

Observation only

Cesarean

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parturients who undergo cesarean section

You may qualify if:

  • all parturients underwent cesarean section at Far Eastern Memorial Hospital during 2012-2016

You may not qualify if:

  • missing data can't be collect during medical chart review

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

December 30, 2017

First Posted

January 5, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)