Podocyturia as Predictive Factor for Pre-eclampsia

NCT03316430 | Completed

• 1 other identifier: 69HCL17_0516
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Podocyn could be identified in the urine, before proteinuria, a key element in the diagnostic of pre-eclampsia. Preventive treatment using aspirin could be administrated in early pregnancy. We hypothesized that podocyturia could be an early indicator of preeclampsia. This is a prospective, non-interventional, monocentric study.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• Occurrence of pre-eclampsia

  Occurrence of pre-eclampsia during pregnancy

  At childbirth (around 8 months)

Study Arms (1)

Patients

Patients coming before 16 weeks of gestation at their first planned prenatal visit at the Hôpital Femme Mère Enfant, who planned to deliver at the Hôpital Femme Mère Enfant

Other: Podocyturia quantification

Interventions

Podocyturia quantification OTHER

Podocyturia quantification at first planned prenatal care visit before 16 weeks of gestation

Patients

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients coming before 16 weeks of gestation at their first planned prenatal visit at the Hôpital Femme Mère Enfant, who planned to deliver at the Hôpital Femme Mère Enfant

You may qualify if:

• women aged 18 years or more
• single pregnancy
• first planned prenatal visit before 16 weeks of gestation
• planned delivery at Hôpital Femme Mère Enfant in Lyon, France
• patient receiving information and non opposition to participate

You may not qualify if:

• multiple pregnancy
• pregnancy stopped
• antecedent of nephropathy
• inability to understand information provided
• prisoner or under administrative supervision
• fetal malformation, chromosomal anomalies
• preterm delivery for other reason that any hypertensive disorder of pregnancy or Intrauterine growth restriction

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France

Bron, 69677, France

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 20, 2017
• Study Start: May 15, 2019
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)