Pre-EclampsiaPEPOD2NCT03316391
Association Between Pococyturia and Pre-eclampsia Severity
An observational study of Pre-Eclampsia, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. 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?
- Dosage of urinary podocyturia
- How many people
- 14 participants
- Where
- 2 sitesFrance
- Study dates
- 22 May 2019to 2 Mar 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 in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant
Who may be able to join
- women aged 18 years or more
- single pregnancy
- admission for pre-eclampsia
- patient receiving information and non-opposition to participate
Who cannot join
- multiple pregnancy
- in utero fetal demise excepted if associated with pre-eclampsia
- antecedent of nephropathy
- fetal malformation, chromosomal anomalies
- inability to understand information provided
- prisoner or under administrative supervision
Trial locations and contacts
2 sites in 1 country.
France2 sites
Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
Bron, 69677
Service de gynécologie-obstétrique
Pierre-Bénite, Rhône, 69495
About this study
Official title: Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity
Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. A simple and rapid indicator for severe preeclampsia would help clinicians to make appropriate decision in patient management. We hypothesized that urinary podocyturia is correlated to preeclampsia severity. This is a prospective, non-interventional, monocentric study.
- Conditions
- Pre-Eclampsia
- Being tested
- Dosage of urinary podocyturia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosage of urinary podocyturiaOther
Dosage of urinary podocyturia at admission, delivery and post-partum visit
| Study group | Role | What they receive |
|---|---|---|
| Pre-eclampsia | Patients in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant Receives: Other: Dosage of urinary podocyturia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of pre-eclampsia
Severe preeclampsia is defined by preeclampsia with at least one of the following criteria :
- severe hypertension (PAS ≥ 160 mmHg et/ou PAD ≥ 110 mmHg)
- Renal impairment with: oliguria <500 ml / 24h or creatinine> 135 μmol / L or proteinuria> 5 g/d
- acute lung edema or persistent epigastric bar or HELLP syndrome
- eclampsia or rebellious neurological disorders (visual disturbances, polykinetic ROT, headache),
- thrombocytopenia <100 G / L
- Retro Placental Hematoma (HRP) or fetal repercussion.
Measured: at childbirth (maximum 10 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 start22 May 2019
- Primary completion2 Mar 2021
- Study completion2 Mar 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 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
- NCT03316391
- Sponsor's protocol ID
- 69HCL17_0517
- Acronym
- PEPOD2
- Status last verified
- Jul 2025
- First submitted
- 17 Oct 2017
- Last updated
- 24 Jul 2025
- 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity
- ClinicalTrials.gov ID
- NCT03316391
- Acronym / sponsor ID
- PEPOD2 / 69HCL17_0517
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 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. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. A simple and rapid indicator for severe preeclampsia would help clinicians to make appropriate decision in patient management. We hypothesized that urinary podocyturia is correlated to preeclampsia severity. This is a prospective, non-interventional, monocentric study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-eclampsia | – | Other: Dosage of urinary podocyturiaPatients in hospital for pre-eclampsia at the Hopital 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 in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant
Key inclusion criteria (4 listed)
- women aged 18 years or more
- single pregnancy
- admission for pre-eclampsia
- patient receiving information and non-opposition to participate
Key exclusion criteria (6 listed)
- multiple pregnancy
- in utero fetal demise excepted if associated with pre-eclampsia
- antecedent of nephropathy
- fetal malformation, chromosomal anomalies
- inability to understand information provided
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 |
|---|---|---|
| Dosage of urinary podocyturiaDosage of urinary podocyturia at admission, delivery and post-partum visit | Other | Pre-eclampsia |
Primary outcome
Severity of pre-eclampsia
Time frame: at childbirth (maximum 10 months)
Severe preeclampsia is defined by preeclampsia with at least one of the following criteria : * severe hypertension (PAS ≥ 160 mmHg et/ou PAD ≥ 110 mmHg) * Renal impairment with: oliguria <500 ml / 24h or creatinine> 135 μmol / L or proteinuria> 5 g/d * acute lung edema or persistent epigastric bar or HELLP syndrome * eclampsia or rebellious neurological disorders (visual disturbances, polykinetic ROT, headache), * thrombocytopenia <100 G / L * Retro Placental Hematoma (HRP) or fetal repercussion.
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 24 Jul 2025.
- 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.
2 sites 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 2 sites 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 4 inclusion and 6 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Severity of pre-eclampsia (time frame: at childbirth (maximum 10 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 24 Jul 2025.