Pregnancy RelatedANNOTEPNCT03981653
ANgiogenic Function at NOrmal TErm on Placenta
An observational study of Pregnancy Related, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
In vivo and ex vivo study of trophoblastic angiogenic trophoblastic function in placentas from normal pregnancies, at term Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2019to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with a progressive, full-term pregnancy
Who may be able to join
- Pregnancies with scheduled cesarean delivery >37 weeks of amenorrhea:
- strictly normal pregnancies
- complicated pregnancies of gestational diabetes, insulin-treated or not
- complicated pregnancies due to pregnancy cholestasis
- spontaneous or in vitro fecondation (IVF) / Intracytoplasmic sperm injection (ICSI) pregnancies with or without oocyte donation
Who cannot join
- Patient's opposition
- Age < 18 years old
- Women under the protection of justice
- Multiple pregnancy
- Known major fetal malformation
- Pre-eclampsia and intrauterine growth retardation
Show all 11Show fewer
- Placental insertionnomaly
- Type 1 diabetes
- HIV-positive patient with HIV/hepatisis C virus (HCV) regardless of viral load
- Patient in labour at the time of Caesarean section
- Patient whose medical history results in medication being taken in pregnancy courses that may interfere with the biology of the trophoblast (immunomodulators in case of autoimmune diseases, anti-rejection drugs in case of transplant patients)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Lecarpentier Edouard, MD, 00145175543, edouard.lecarpentier@chicreteil.fr
About this study
Official title: Angiogenic Function at Normal Term on Placenta
In vivo and ex vivo study of trophoblastic angiogenic trophoblastic function in placentas from normal pregnancies, at term
Read the detailed description
The objective of this study is to better understand the regulation of trophoblast expression of pro- and antiangiogenic factors such as placenta growth factor (PlGF) or Soluble FMS like tyrosin-kinase-1 (sFlt-1), and more particularly on human differentiated trophoblastic cells from "healthy" placentas. The measurement of the variation in gene and protein expression of placental angiogenic factors will provide a better understanding of their pathophysiology.
Secondary objectives are the study of trophoblastic differentiation and placental functions, and the study of the impact of chemical compounds on the biological functions of the placenta. To do this, these "healthy" placentas may be exposed to different factors that promote the occurrence of specific pregnancy pathologies such as pre-eclampsia and vascular intrauterine growth restriction (IUGR), caused by placental dysfunction. This will make it possible to test molecules and vector approaches targeted directly at the trophoblast, in order to consider therapeutic targets, which do not exist to date.
- Conditions
- Pregnancy Related
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of placental angiogenic factors
Variation in the gene and protein expression of placental angiogenic factors on healthy placentas
Measured: day 0
Secondary outcomes (2)
Level of sFlt-1 (Soluble FMS like tyrosin-kinase-1)
Sflt-1 levels when the placenta is exposed to factors that promote the development of vascular pregnancy diseases
Measured: day 1
Level of PlGF (Placental Growth Factor)
PlGF levels when the placenta is exposed to factors that promote the development of vascular pregnancy diseases
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start20 Mar 2019
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981653
- Sponsor's protocol ID
- ANNOTEP
- Acronym
- ANNOTEP
- Status last verified
- Dec 2022
- First submitted
- 7 Jun 2019
- Last updated
- 21 Dec 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 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiogenic Function at Normal Term on Placenta
- ClinicalTrials.gov ID
- NCT03981653
- Acronym / sponsor ID
- ANNOTEP / ANNOTEP
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 11 Jun 2019 (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.
In vivo and ex vivo study of trophoblastic angiogenic trophoblastic function in placentas from normal pregnancies, at term
Detailed description
The objective of this study is to better understand the regulation of trophoblast expression of pro- and antiangiogenic factors such as placenta growth factor (PlGF) or Soluble FMS like tyrosin-kinase-1 (sFlt-1), and more particularly on human differentiated trophoblastic cells from "healthy" placentas. The measurement of the variation in gene and protein expression of placental angiogenic factors will provide a better understanding of their pathophysiology.
Secondary objectives are the study of trophoblastic differentiation and placental functions, and the study of the impact of chemical compounds on the biological functions of the placenta. To do this, these "healthy" placentas may be exposed to different factors that promote the occurrence of specific pregnancy pathologies such as pre-eclampsia and vascular intrauterine growth restriction (IUGR), caused by placental dysfunction. This will make it possible to test molecules and vector approaches targeted directly at the trophoblast, in order to consider therapeutic targets, which do not exist to date.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a progressive, full-term pregnancy
Key inclusion criteria (5 listed)
- Pregnancies with scheduled cesarean delivery >37 weeks of amenorrhea:
- strictly normal pregnancies
- complicated pregnancies of gestational diabetes, insulin-treated or not
- complicated pregnancies due to pregnancy cholestasis
- spontaneous or in vitro fecondation (IVF) / Intracytoplasmic sperm injection (ICSI) pregnancies with or without oocyte donation
Key exclusion criteria (11 listed)
- Patient's opposition
- Age < 18 years old
- Women under the protection of justice
- Multiple pregnancy
- Known major fetal malformation
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
Level of placental angiogenic factors
Time frame: day 0
Variation in the gene and protein expression of placental angiogenic factors on healthy placentas
2 secondary outcomes
Level of sFlt-1 (Soluble FMS like tyrosin-kinase-1)
Time frame: day 1
Level of PlGF (Placental Growth Factor)
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 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.
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 Pregnancy Related, run by Centre Hospitalier Intercommunal Creteil 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 11 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: looking for participants now, as of the sponsor's last update on 21 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact camille JUNG, MD (00157022268, camille.jung@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of placental angiogenic factors (time frame: day 0). 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 21 Dec 2022.