PreeclampsiaNCT01914809
Micro Array Analysis in Preeclampsia
A study testing samples blood and biopsy placentaire in people with Preeclampsia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Preeclampsia is a frequent pathology. His etiology is doubtful. Targets : The study target is to identify a risk of preeclampsia group obtained with transcriptom analysis from circulating peripheric cells. Design: Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- samples blood and biopsy placentaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2011to 25 Jan 2021
- Phase
- Interventional
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- A prééclampsie (blood pressure superior to 140 mmHg and to 90 mmHg) and at least a cross of protein in the strip and/or more of 300mg / 24h after 20 LIMITED COMPANIES and before 34 limited companies.
- An informed consent signed by the patient will necessarily have to be obtained.
- Woman having been taken care during the pregnancy or at the time of the childbirth(delivery) by one of the participating teams to the current project.
- Caucasian Patient
- Wait primigeste and nullipare
Who cannot join
- Major Patient protected by the law.
- Patient deprived of freedom for administrative or judicial reasons.
- Patient not benefiting from a national insurance scheme.
- Refusal of the patient to participate in the study.
- Not Caucasian Patient
- Multipare Wait
Show all 10Show fewer
- Multiple Pregnancy
- Existence of foetal deformation explaining a delay of growth or a foetal death in utero.
- Age 18 years and > 40 years.
- Absence of written consent or impossibility to receive the written consent (language or understanding).
Trial locations and contacts
1 site in 1 country.
florence bretelle contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
florence bretelle, florence.bretelle@ap-hm.fr
florence bretelle
About this study
Preeclampsia is a frequent pathology. His etiology is doubtful.
Targets :
Read more
The study target is to identify a risk of preeclampsia group obtained with transcriptom analysis from circulating peripheric cells.
Design:
Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).
The study of the transcriptional history of peripheral blood cells of 2patients groups:
- A patient group with a preeclampsia before 34 SA
- A patient group with a normal pregnancy paired on main confusion factors. Blood sampling will be collected at the diagnosis and 8 weeks after delivery.
Results and perspectives
- Obtain a transcriptionnal signature of preeclampsia
- To identify new mechanism of the disease
- Identification of a specific transcriptom analysis with the comparison after delivery For long-term, the target is to identify risk patient in order to conduct easily preventive clinical trials in preeclamsia (primary prevention) and to consider a specific follow-up for risk patients.
- Conditions
- Preeclampsia
- Being tested
- samples blood, biopsy placentaire
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
samples bloodOther
biopsy placentaireOther
| Study group | Role | What they receive |
|---|---|---|
| group with a preeclampsia before 34 SA | Experimental | Not described Receives: Other: samples blood; Other: biopsy placentaire |
| group with a normal pregnancy | Other | Not described Receives: Other: samples blood; Other: biopsy placentaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive markers of preeclampsia
blood samples
Measured: 36 months
Secondary outcomes (1)
analysis of placental transcriptional profile.
biopsie placentaire
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study start15 Jun 2011
- Primary completion25 Jan 2021 (estimated)
- Study completion25 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914809
- Sponsor's protocol ID
- 2010-A00633-36
- Other IDs
- 2010-04
- Status last verified
- Sep 2020
- First submitted
- 11 Jul 2013
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro Array Analysis in Preeclampsia
- ClinicalTrials.gov ID
- NCT01914809
- Acronym / sponsor ID
- 2010-A00633-36
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Jun 2011 (actual)
- Primary completion
- 25 Jan 2021 (estimated)
- Study completion
- 25 Jan 2021 (estimated)
- First posted
- 2 Aug 2013 (estimated)
- 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.
Preeclampsia is a frequent pathology. His etiology is doubtful.
Targets :
The study target is to identify a risk of preeclampsia group obtained with transcriptom analysis from circulating peripheric cells.
Design:
Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).
The study of the transcriptional history of peripheral blood cells of 2patients groups:
- A patient group with a preeclampsia before 34 SA
- A patient group with a normal pregnancy paired on main confusion factors. Blood sampling will be collected at the diagnosis and 8 weeks after delivery.
Results and perspectives
- Obtain a transcriptionnal signature of preeclampsia
- To identify new mechanism of the disease
- Identification of a specific transcriptom analysis with the comparison after delivery For long-term, the target is to identify risk patient in order to conduct easily preventive clinical trials in preeclamsia (primary prevention) and to consider a specific follow-up for risk patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with a preeclampsia before 34 SA | Experimental | Other: samples blood, Other: biopsy placentaire |
| group with a normal pregnancy | Other | Other: samples blood, Other: biopsy placentaire |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A prééclampsie (blood pressure superior to 140 mmHg and to 90 mmHg) and at least a cross of protein in the strip and/or more of 300mg / 24h after 20 LIMITED COMPANIES and before 34 limited companies.
- An informed consent signed by the patient will necessarily have to be obtained.
- Woman having been taken care during the pregnancy or at the time of the childbirth(delivery) by one of the participating teams to the current project.
- Caucasian Patient
- Wait primigeste and nullipare
Key exclusion criteria (10 listed)
- Major Patient protected by the law.
- Patient deprived of freedom for administrative or judicial reasons.
- Patient not benefiting from a national insurance scheme.
- Refusal of the patient to participate in the study.
- Not Caucasian Patient
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 |
|---|---|---|
| samples blood | Other | group with a normal pregnancy, group with a preeclampsia before 34 SA |
| biopsy placentaire | Other | group with a normal pregnancy, group with a preeclampsia before 34 SA |
Primary outcome
predictive markers of preeclampsia
Time frame: 36 months
blood samples
1 secondary outcome
analysis of placental transcriptional profile.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
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Preeclampsia
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.
florence bretelle contact
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing samples blood and biopsy placentaire in people with Preeclampsia, run by Assistance Publique Hopitaux De Marseille 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 10 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: status not confirmed, as of the sponsor's last update on 25 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact florence bretelle (florence.bretelle@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive markers of preeclampsia (time frame: 36 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 25 Sep 2020.