PRECEE2 Perinatal Research | NCT06933719

Studies
PRECEE2 Perinatal Research

NCT06933719

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Not yet recruiting

Last Update Posted

Apr 18, 2025Actual

Enrollment

30,000Estimated

Phase

Not provided

Conditions

Pregnancy Complications

Interventions

Study on existing health data

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2025Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Jan 31, 2026Estimated

First Submitted Date

Mar 27, 2025

First Submission Date that Met QC Criteria

Apr 10, 2025

First Posted Date

Apr 18, 2025Actual

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

Apr 10, 2025

Last Update Posted Date

Apr 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The aim of this study is to analyze the relationship between complications and adverse pregnancy outcomes and exposure to environmental factors in women living in Franche-Comté who gave birth between 2011 and 2025 at Besancon University Hospital.

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

30,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Study on existing health data	Other	Study on existing health data

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pregnancy complications	Description of Pregnancy Complications	at birth

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women who gave birth at the CHUB between 01/01/2011 and 12/31/2025
who have not expressed any objection to the processing of their data.

Exclusion Criteria:

Legal incapacity or limited legal capacity
Subject is within the exclusion period of another study or is excluded from the "national volunteer file".
Subject refusing the collection of his/her medical data.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women who gave birth at the CHUB between 01/01/2011 and 12/31/2025

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011248	Pregnancy Complications

Ancestor Terms

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided