Pre-EclampsiaPEPOD1NCT03316430
Podocyturia as Predictive Factor for Pre-eclampsia
An observational study of Pre-Eclampsia, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Podocyturia quantification
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2019to 7 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
Bron, 69677
About this study
Official title: 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.
- Conditions
- Pre-Eclampsia
- Being tested
- Podocyturia quantification
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podocyturia quantificationOther
Podocyturia quantification at first planned prenatal care visit before 16 weeks of gestation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Podocyturia quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of pre-eclampsia
Occurrence of pre-eclampsia during pregnancy
Measured: At childbirth (around 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start15 May 2019
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316430
- Sponsor's protocol ID
- 69HCL17_0516
- Acronym
- PEPOD1
- Status last verified
- Jan 2022
- First submitted
- 17 Oct 2017
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study : Podocyturia as Predictive Factor for Pre-eclampsia
- ClinicalTrials.gov ID
- NCT03316430
- Acronym / sponsor ID
- PEPOD1 / 69HCL17_0516
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Podocyturia quantificationPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- multiple pregnancy
- pregnancy stopped
- antecedent of nephropathy
- inability to understand information provided
- prisoner or under administrative supervision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Podocyturia quantificationPodocyturia quantification at first planned prenatal care visit before 16 weeks of gestation | Other | Patients |
Primary outcome
Occurrence of pre-eclampsia
Time frame: At childbirth (around 8 months)
Occurrence of pre-eclampsia during pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of pre-eclampsia (time frame: At childbirth (around 8 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.