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CompletedNCT03316430PEPOD1Updated Jan 12, 2022

Podocyturia as Predictive Factor for Pre-eclampsia

An observational study in Pre-Eclampsia, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-12.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Pre-Eclampsia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherPodocyturia quantification

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

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What researchers measure

Primary outcomes

  1. Occurrence of pre-eclampsia

    Occurrence of pre-eclampsia during pregnancy

    Time frame: At childbirth (around 8 months)

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Study locations

1 site
  • Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
    Bron, 69677, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03316430
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Oct 20, 2017
Start date
May 15, 2019
Primary completion
Dec 7, 2021
Completion
Dec 7, 2021
Last update
Jan 12, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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