Association Between Pococyturia and Pre-eclampsia Severity | NCT03316391

Studies
Association Between Pococyturia and Pre-eclampsia Severity

NCT03316391

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Jul 24, 2025Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Pre-Eclampsia

Interventions

Dosage of urinary podocyturia

Countries

France

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

Jul 2025

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

May 22, 2019Actual

Primary Completion Date

Mar 2, 2021Actual

Completion Date

Mar 2, 2021Actual

First Submitted Date

Oct 17, 2017

First Submission Date that Met QC Criteria

Oct 17, 2017

First Posted Date

Oct 20, 2017Actual

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

Jul 21, 2025

Last Update Posted Date

Jul 24, 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. A simple and rapid indicator for severe preeclampsia would help clinicians to make appropriate decision in patient management. We hypothesized that urinary podocyturia is correlated to preeclampsia severity. This is a prospective, non-interventional, monocentric study.

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pre-eclampsia		Patients in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant	Other: Dosage of urinary podocyturia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dosage of urinary podocyturia	Other	Dosage of urinary podocyturia at admission, delivery and post-partum visit	Pre-eclampsia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of pre-eclampsia	Severe preeclampsia is defined by preeclampsia with at least one of the following criteria : severe hypertension (PAS ≥ 160 mmHg et/ou PAD ≥ 110 mmHg) Renal impairment with: oliguria <500 ml / 24h or creatinine> 135 μmol / L or proteinuria> 5 g/d acute lung edema or persistent epigastric bar or HELLP syndrome eclampsia or rebellious neurological disorders (visual disturbances, polykinetic ROT, headache), thrombocytopenia <100 G / L Retro Placental Hematoma (HRP) or fetal repercussion.	at childbirth (maximum 10 months)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women aged 18 years or more
single pregnancy
admission for pre-eclampsia
patient receiving information and non-opposition to participate

Exclusion Criteria:

multiple pregnancy
in utero fetal demise excepted if associated with pre-eclampsia
antecedent of nephropathy
fetal malformation, chromosomal anomalies
inability to understand information provided
prisoner or under administrative supervision

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de gynécologie-obstétrique		Pierre-Bénite	Rhône	69495	France
Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France

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

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided