PreeclampsiaAPHERESENCT03188900
Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia
An observational study of Preeclampsia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to setup a collection of maternal plasma and serum from patients with preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on extra-corporal removal of sFlt-1 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- A collection of maternal plasma and serum
- How many people
- 236 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2017to 12 Jun 2019
- How long will I take part?
- 22 Weeks
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnancy with preeclampsia and without preeclampsia
Who may be able to join
- Age from 18 to 50 years old
- Singleton pregnancies between 20 and 41 weeks of gestation
- Preeclampsia
- Normal pregnancy
Who cannot join
- Age<18
- Infectious disease: HIV, HBV or HCV
- Multiple pregnancies
- Opposition of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Therapeutic Strategy Against Preeclampsia: Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1
The aim of the study is to setup a collection of maternal plasma and serum from patients with preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on extra-corporal removal of sFlt-1
Read the detailed description
A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP) :
- Between 20WG and 23WG+6D : 20 patients with PE and 30 patients with NP
- Between 24WG and 27WG+6D : 20 patients with PE and 30 patients with NP
- Between 28WG and 31WG+6D : 20 patients with PE and 30 patients with NP
- Between 32WG and 35WG+6D : 20 patients with PE and 30 patients with NP
- Between 36WG and 40WG+6D : 20 patients with PE and 30 patients with NP
- Conditions
- Preeclampsia
- Being tested
- A collection of maternal plasma and serum
- Keywords
- Preeclampsia, apheresis, sflt-1
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A collection of maternal plasma and serumBiological
A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)
| Study group | Role | What they receive |
|---|---|---|
| preeclampsia | pregnancy with preeclampsia Receives: Biological: A collection of maternal plasma and serum | |
| control | pregnancy without preeclampsia Receives: Biological: A collection of maternal plasma and serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio sFlt-1/PlGF
measurement of of sFlT-1 and PlGF
Measured: Day 0
Secondary outcomes (1)
Kinetics of these ratios sFlt-1/PlGF during pregnancy
measurement of of sFlT-1 and PlGF at many times
Measured: until 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start12 Jun 2017
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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-control
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
- Target duration
- 22 Weeks
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR-S 1139, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Edouard Lecarpentier, MD, PhD, Study director, Centre Hospitalier intercommunal de Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188900
- Sponsor's protocol ID
- SC3455
- Acronym
- APHERESE
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2017
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsatsaris V, Goffin F, Munaut C, Brichant JF, Pignon MR, Noel A, Schaaps JP, Cabrol D, Frankenne F, Foidart JM. Overexpression of the soluble vascular endothelial growth factor receptor in preeclamptic patients: pathophysiological consequences. J Clin Endocrinol Metab. 2003 Nov;88(11):5555-63. doi: 10.1210/jc.2003-030528.
PubMed 14602804Thadhani R, Hagmann H, Schaarschmidt W, Roth B, Cingoez T, Karumanchi SA, Wenger J, Lucchesi KJ, Tamez H, Lindner T, Fridman A, Thome U, Kribs A, Danner M, Hamacher S, Mallmann P, Stepan H, Benzing T. Removal of Soluble Fms-Like Tyrosine Kinase-1 by Dextran Sulfate Apheresis in Preeclampsia. J Am Soc Nephrol. 2016 Mar;27(3):903-13. doi: 10.1681/ASN.2015020157. Epub 2015 Sep 24.
PubMed 26405111Levine RJ, Maynard SE, Qian C, Lim KH, England LJ, Yu KF, Schisterman EF, Thadhani R, Sachs BP, Epstein FH, Sibai BM, Sukhatme VP, Karumanchi SA. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med. 2004 Feb 12;350(7):672-83. doi: 10.1056/NEJMoa031884. Epub 2004 Feb 5.
PubMed 14764923Trapiella-Alfonso L, Alexandre L, Fraichard C, Pons K, Dumas S, Huart L, Gaucher JF, Hebert-Schuster M, Guibourdenche J, Fournier T, Vidal M, Broutin I, Lecomte-Raclet L, Malaquin L, Descroix S, Tsatsaris V, Gagey-Eilstein N, Lecarpentier E. VEGF (Vascular Endothelial Growth Factor) Functionalized Magnetic Beads in a Microfluidic Device to Improve the Angiogenic Balance in Preeclampsia. Hypertension. 2019 Jul;74(1):145-153. doi: 10.1161/HYPERTENSIONAHA.118.12380. Epub 2019 May 13.
PubMed 31079531
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Therapeutic Strategy Against Preeclampsia: Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1
- ClinicalTrials.gov ID
- NCT03188900
- Acronym / sponsor ID
- APHERESE / SC3455
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, apheresis, sflt-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- INSERM UMR-S 1139, URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 16 Jun 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.
The aim of the study is to setup a collection of maternal plasma and serum from patients with preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on extra-corporal removal of sFlt-1
Detailed description
A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP) :
- Between 20WG and 23WG+6D : 20 patients with PE and 30 patients with NP
- Between 24WG and 27WG+6D : 20 patients with PE and 30 patients with NP
- Between 28WG and 31WG+6D : 20 patients with PE and 30 patients with NP
- Between 32WG and 35WG+6D : 20 patients with PE and 30 patients with NP
- Between 36WG and 40WG+6D : 20 patients with PE and 30 patients with NP
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 22 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preeclampsia | – | Biological: A collection of maternal plasma and serumpregnancy with preeclampsia |
| control | – | Biological: A collection of maternal plasma and serumpregnancy without preeclampsia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnancy with preeclampsia and without preeclampsia
Key inclusion criteria (4 listed)
- Age from 18 to 50 years old
- Singleton pregnancies between 20 and 41 weeks of gestation
- Preeclampsia
- Normal pregnancy
Key exclusion criteria (4 listed)
- Age<18
- Infectious disease: HIV, HBV or HCV
- Multiple pregnancies
- Opposition of the 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 |
|---|---|---|
| A collection of maternal plasma and serumA collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP) | Biological | control, preeclampsia |
Primary outcome
ratio sFlt-1/PlGF
Time frame: Day 0
measurement of of sFlT-1 and PlGF
1 secondary outcome
Kinetics of these ratios sFlt-1/PlGF during pregnancy
Time frame: until 5 month
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 27 Mar 2026.
- Background: PubMed 14602804Tsatsaris V, Goffin F, Munaut C, Brichant JF, Pignon MR, Noel A, Schaaps JP, Cabrol D, Frankenne F, Foidart JM. Overexpression of the soluble vascular endothelial growth factor receptor in preeclamptic patients: pathophysiological consequences. J Clin Endocrinol Metab. 2003 Nov;88(11):5555-63. doi: 10.1210/jc.2003-030528.
- Background: PubMed 26405111Thadhani R, Hagmann H, Schaarschmidt W, Roth B, Cingoez T, Karumanchi SA, Wenger J, Lucchesi KJ, Tamez H, Lindner T, Fridman A, Thome U, Kribs A, Danner M, Hamacher S, Mallmann P, Stepan H, Benzing T. Removal of Soluble Fms-Like Tyrosine Kinase-1 by Dextran Sulfate Apheresis in Preeclampsia. J Am Soc Nephrol. 2016 Mar;27(3):903-13. doi: 10.1681/ASN.2015020157. Epub 2015 Sep 24.
- Background: PubMed 14764923Levine RJ, Maynard SE, Qian C, Lim KH, England LJ, Yu KF, Schisterman EF, Thadhani R, Sachs BP, Epstein FH, Sibai BM, Sukhatme VP, Karumanchi SA. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med. 2004 Feb 12;350(7):672-83. doi: 10.1056/NEJMoa031884. Epub 2004 Feb 5.
- Results publication: PubMed 31079531Trapiella-Alfonso L, Alexandre L, Fraichard C, Pons K, Dumas S, Huart L, Gaucher JF, Hebert-Schuster M, Guibourdenche J, Fournier T, Vidal M, Broutin I, Lecomte-Raclet L, Malaquin L, Descroix S, Tsatsaris V, Gagey-Eilstein N, Lecarpentier E. VEGF (Vascular Endothelial Growth Factor) Functionalized Magnetic Beads in a Microfluidic Device to Improve the Angiogenic Balance in Preeclampsia. Hypertension. 2019 Jul;74(1):145-153. doi: 10.1161/HYPERTENSIONAHA.118.12380. Epub 2019 May 13.
- 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.
Edouard Lecarpentier, MD, PhD study director
Centre Hospitalier intercommunal de Créteil
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 Preeclampsia, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 4 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 27 Mar 2026. 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?
ratio sFlt-1/PlGF (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188900, which also lists 4 linked publications.
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 27 Mar 2026.