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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

October 17, 2017
October 20, 2017
October 20, 2017
November 2017
April 2019   (Final data collection date for primary outcome measure)
Occurrence of pre-eclampsia [ Time Frame: At childbirth (around 8 months) ]
Occurrence of pre-eclampsia during pregnancy
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Podocyturia as Predictive Factor for Pre-eclampsia
Prospective Study : Podocyturia as Predictive Factor for Pre-eclampsia
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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
Pre-Eclampsia
Other: Podocyturia quantification
Podocyturia quantification at first planned prenatal care visit before 16 weeks of gestation
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
Intervention: Other: Podocyturia quantification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1000
Same as current
April 2019
April 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years and older   (Adult, Older Adult)
No
Contact: Muriel DORET-DION, MD 04 27 85 51 70 ext +33 muriel.doret-dion@chu-lyon.fr
France
 
 
NCT03316430
69HCL17_0516
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Not Provided
Hospices Civils de Lyon
October 2017