Pre-EclampsiaMAPLENCT04389099
MRI Angiography of Physiological and Pathological Pregnancy Placentas Ex-vivo
An observational study of Pre-Eclampsia and Fetal Growth Retardation, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Introduction: The placenta is the organ that permits the maternal-fetal exchange of the oxygen and nutrients. The development of its vascular network occurs in the first trimester. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Fetal Growth Retardation
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2019to 17 Nov 2024
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: * healthy placenta group: 50 inclusion (among which, 10 is to establish the final technical protocol) * pathological placenta group: 60 (30 preeclampsia and 30 intrauterine restricted growth only cases)
Who may be able to join
- already received the complete information about the study and do not express any opposition to the utilisation of their data
- mandatory enrolment in a social security plan
- gestational age more than 30 weeks (and until at term)
- patient with either natural delivery or with cesarean section and whose placenta is naturally completely separated (directed delivery only)
Who cannot join
- younger than 18 years old
- new borns with congenital disease (either suspected at birth or already diagnosed)
- presence of only one umbilical artery
- presence of a maternal pathology: gestational or pre-existing diabetes, autoimmune diseases that may have an impact on placental vascularization (Antiphospholipid Antibody Syndrome, Immune Thrombocytopenia, Myasthenia, Systemic Lupus Erythematosus), cancer,
- do not speak the French language, or inability to understand the given information of the study
- manual delivery
Show all 9Show fewer
- incomplete placenta
- placenta with true marginal insertions (cord insertion within 1 cm of the placental margin) and/or velaments of the cord
- Person referred to Articles L.1121-6 and L-1121-8 of the Public Health Code
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Régional Universitaire de Nancy
Vandœuvre-lès-Nancy, 54500
About this study
Introduction:
The placenta is the organ that permits the maternal-fetal exchange of the oxygen and nutrients. The development of its vascular network occurs in the first trimester. Any deficit during this important angiogenesis procedure can lead to the dysfunction of the placental vasculature, which can potentially cause pathologies including preeclampsia (PE) and intrauterine growth restriction (IUGR). PE concerns 3% of the pregnancy in France. It can occur at any gestational age and leads to serious complications such as eclampsia, the HELLP syndrome or the retro-placental hematoma. IUGR does not only lead to the morbidity and fetal and neonatal mortality, but also has a predisposition for certain pathologies in the adulthood.
Read more
Many groups have studied the placenta vasculature at the microscopic (histological) scale. However, recent studies show that in addition to the damage at the microvasculature level, the macroscopic placental vessel architecture is also altered. Nonetheless, the origin and the etiology of this phenomenon remains unknown.
Since it is difficult to apply in-vivo imaging techniques on pregnant women due to the restriction of usage of contrast agent. Alternatively, ex-vivo MR angiography (MRA) techniques have been developed by our team and others to visualize the entire placental vasculature in a faster way (as compared to corrosion casting). Up to now, only the study of the healthy placenta is done and published. The analysis of the pathological placental vasculature (i.e. PE and IUGR cases) at different gestational age and its comparison to the physiological ones have not been conducted, which will potentially enable a better understanding of the placental vasculature pathology.
Objectives: the main objective of this study is to compare the vasculature architecture of the normal and pathological placentas (with possible alteration in the placental vasculature).
Methods and analysis: This is a monocentric, prospective, controlled but not randomized study. The investigators expect to include 110 women in Nancy. The pregnant women will be recruited when they arrived at the maternity hospital for delivery, for both the physiological and potential pathological cases. The notice of this study will be given. If no opposition is given by the subject, the placenta may be collected. This study will not collect the patient consent but only the opposition declaration will be collected.
- Conditions
- Pre-Eclampsia, Fetal Growth Retardation
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy placenta (control) | Pregnant women without preeclampsia and/or fetal growth restriction | |
| Pathological placenta | Pregnant women with preeclampsia and/or fetal growth restriction divided into two subgroups : preeclampsia with or without fetal growth restriction ; fetal growth restriction without preeclampsia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental vasculature architecture indice: total vascular density
Measured: through study completion, on average of 24 months
Placental vasculature architecture indice: placental artery density (cm3)
Measured: through study completion, on average of 24 months
Placental vasculature architecture indice: placental vien density (cm3)
Measured: through study completion, on average of 24 months
Placental vasculature architecture indice: placental vessel tortuosity
Measured: through study completion, on average of 24 months
Placental vasculature architecture indice: placental vessel tree branching
Measured: through study completion, on average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start18 Nov 2019
- Primary completion17 Nov 2024
- Study completion17 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BERTHOLDT Charline, Central Hospital, Nancy, France
- Investigators
- Charline BERTHOLDT, Study chair, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389099
- Sponsor's protocol ID
- PSS2018/MAPLE-BERTHOLDT/SKJ
- Acronym
- MAPLE
- Status last verified
- Feb 2024
- First submitted
- 6 May 2020
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dap M, Chen B, Banasiak C, Hossu G, Morel O, Beaumont M, Bertholdt C. Magnetic Resonance Imaging Angiography of Physiological and Pathological Pregnancy Placentas Ex Vivo: Protocol for a Prospective Pilot Study. JMIR Res Protoc. 2022 Aug 10;11(8):e35051. doi: 10.2196/35051.
PubMed 35947435
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Angiography of Physiological and Pathological Pregnancy Placentas Ex-vivo
- ClinicalTrials.gov ID
- NCT04389099
- Acronym / sponsor ID
- MAPLE / PSS2018/MAPLE-BERTHOLDT/SKJ
- Conditions
- Pre-Eclampsia, Fetal Growth Retardation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 17 Nov 2024 (actual)
- Study completion
- 17 Nov 2024 (actual)
- First posted
- 15 May 2020 (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.
Introduction:
The placenta is the organ that permits the maternal-fetal exchange of the oxygen and nutrients. The development of its vascular network occurs in the first trimester. Any deficit during this important angiogenesis procedure can lead to the dysfunction of the placental vasculature, which can potentially cause pathologies including preeclampsia (PE) and intrauterine growth restriction (IUGR). PE concerns 3% of the pregnancy in France. It can occur at any gestational age and leads to serious complications such as eclampsia, the HELLP syndrome or the retro-placental hematoma. IUGR does not only lead to the morbidity and fetal and neonatal mortality, but also has a predisposition for certain pathologies in the adulthood.
Many groups have studied the placenta vasculature at the microscopic (histological) scale. However, recent studies show that in addition to the damage at the microvasculature level, the macroscopic placental vessel architecture is also altered. Nonetheless, the origin and the etiology of this phenomenon remains unknown.
Since it is difficult to apply in-vivo imaging techniques on pregnant women due to the restriction of usage of contrast agent. Alternatively, ex-vivo MR angiography (MRA) techniques have been developed by our team and others to visualize the entire placental vasculature in a faster way (as compared to corrosion casting). Up to now, only the study of the healthy placenta is done and published. The analysis of the pathological placental vasculature (i.e. PE and IUGR cases) at different gestational age and its comparison to the physiological ones have not been conducted, which will potentially enable a better understanding of the placental vasculature pathology.
Objectives: the main objective of this study is to compare the vasculature architecture of the normal and pathological placentas (with possible alteration in the placental vasculature).
Methods and analysis: This is a monocentric, prospective, controlled but not randomized study. The investigators expect to include 110 women in Nancy. The pregnant women will be recruited when they arrived at the maternity hospital for delivery, for both the physiological and potential pathological cases. The notice of this study will be given. If no opposition is given by the subject, the placenta may be collected. This study will not collect the patient consent but only the opposition declaration will be collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy placenta (control) | – | –Pregnant women without preeclampsia and/or fetal growth restriction |
| Pathological placenta | – | –Pregnant women with preeclampsia and/or fetal growth restriction divided into two subgroups : preeclampsia with or without fetal growth restriction ; fetal growth restriction without preeclampsia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * healthy placenta group: 50 inclusion (among which, 10 is to establish the final technical protocol) * pathological placenta group: 60 (30 preeclampsia and 30 intrauterine restricted growth only cases)
Key inclusion criteria (4 listed)
- already received the complete information about the study and do not express any opposition to the utilisation of their data
- mandatory enrolment in a social security plan
- gestational age more than 30 weeks (and until at term)
- patient with either natural delivery or with cesarean section and whose placenta is naturally completely separated (directed delivery only)
Key exclusion criteria (9 listed)
- younger than 18 years old
- new borns with congenital disease (either suspected at birth or already diagnosed)
- presence of only one umbilical artery
- presence of a maternal pathology: gestational or pre-existing diabetes, autoimmune diseases that may have an impact on placental vascularization (Antiphospholipid Antibody Syndrome, Immune Thrombocytopenia, Myasthenia, Systemic Lupus Erythematosus), cancer,
- do not speak the French language, or inability to understand the given information of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Placental vasculature architecture indice: total vascular density
Time frame: through study completion, on average of 24 months
Placental vasculature architecture indice: placental artery density (cm3)
Time frame: through study completion, on average of 24 months
Placental vasculature architecture indice: placental vien density (cm3)
Time frame: through study completion, on average of 24 months
Placental vasculature architecture indice: placental vessel tortuosity
Time frame: through study completion, on average of 24 months
Placental vasculature architecture indice: placental vessel tree branching
Time frame: through study completion, on average of 24 months
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 13 Feb 2025.
- Derived from this study: PubMed 35947435Dap M, Chen B, Banasiak C, Hossu G, Morel O, Beaumont M, Bertholdt C. Magnetic Resonance Imaging Angiography of Physiological and Pathological Pregnancy Placentas Ex Vivo: Protocol for a Prospective Pilot Study. JMIR Res Protoc. 2022 Aug 10;11(8):e35051. doi: 10.2196/35051.
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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.
Charline BERTHOLDT study chair
Central Hospital, Nancy, France
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 and Fetal Growth Retardation, run by Central Hospital, Nancy, France 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 9 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 13 Feb 2025. 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?
Placental vasculature architecture indice: total vascular density (time frame: through study completion, on average of 24 months). The study lists 5 primary outcomes in all. 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 NCT04389099, which also lists 1 linked publication.
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 13 Feb 2025.