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Podocyturia as Predictive Factor for Pre-eclampsia (PEPOD1)

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ClinicalTrials.gov Identifier: NCT03316430
Recruitment Status : Not yet recruiting
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Pre-Eclampsia Other: Podocyturia quantification

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study : Podocyturia as Predictive Factor for Pre-eclampsia
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Podocyturia quantification at first planned prenatal care visit before 16 weeks of gestation




Primary Outcome Measures :
  1. Occurrence of pre-eclampsia [ Time Frame: At childbirth (around 8 months) ]
    Occurrence of pre-eclampsia during pregnancy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316430


Contacts
Contact: Muriel DORET-DION, MD 04 27 85 51 70 ext +33 muriel.doret-dion@chu-lyon.fr

Locations
France
Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France Not yet recruiting
Bron, France, 69677
Contact: Muriel DORET-DION, MD    04 27 85 51 70 ext +33    muriel.doret-dion@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03316430     History of Changes
Other Study ID Numbers: 69HCL17_0516
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications