Retrospective Analysis of Hospital Medical Records on Med... | NCT02842216

Studies
Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women

NCT02842216

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Aug 22, 2017Actual

Enrollment

1,200Actual

Phase

Not provided

Conditions

Medication and Supplement Use During Pregnancy

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Aug 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Jul 14, 2016

First Submission Date that Met QC Criteria

Jul 21, 2016

First Posted Date

Jul 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2017

Last Update Posted Date

Aug 22, 2017Actual

Name	Class
Universitaire Ziekenhuizen KU Leuven	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Monocentric study in University Hospitals Leuven (campus Gasthuisberg).

Hospital medical records from all pregnant women who delivered between 01/07/2015 and 31/12/2015 in University Hospitals will be analyzed for the presence of medication and supplements.

Some demographic and obstetric parameters will be collected as well.

The anonymized dataset will be analyzed using descriptive statistics (Excel). There will be no intervention among the selected sample.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of registered medicines and supplements in hospital medical records of Belgian pregnant women		Hospital medical records from 11 months before delivery until 1 month postpartum

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All pregnant women who delivered in the University Hospital of Leuven between 01/07/2015 and 31/12/2015

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pregnant women who delivered in the University Hospital of Leuven

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided