Pregnancy RelatedVilliRNAseqNCT06427408
Longitudinal Study of Gene Expression in the Human Placenta During First-trimester and Full-term Pregnancy at the Single Cell Level
An observational study of Pregnancy Related, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The single nucleus RNA-seq approach allows the placental transcriptome to be analyzed from nuclei, thus preserving the integrity of placental syncytium. This approach is feasible on small fragments of villi and offers for the first time the possibility to consider the characterization of gene expression within the… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Non applicable
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2026to Feb 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women in their pregnancy follow-up at the Maternité Port-Royal-Cochin
Who may be able to join
- Age 18 to 50
- Progressive monofoetal pregnancy between 11 and 15 weeks of amenorrhea
- Patient with prenatal medical indication and requesting chorionic villus biopsy with cytogenetic analysis or molecular genetics
- Patient scheduled for delivery at Port-Royal Maternity Hospital
Who cannot join
- Minor patient
- Multiple pregnancy
- Patient's objection
- Without health insurance
- Patient under guardianship or curatorship
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
Maternité Port-Royal, Cochin hospital
Paris, IDF, 75014
Hélène COLLINOT, MD, 0033 1 58 41 38 19
About this study
Official title: Cellular Transcriptomic Trajectory of the Human Placenta During Pregnancy
The single nucleus RNA-seq approach allows the placental transcriptome to be analyzed from nuclei, thus preserving the integrity of placental syncytium. This approach is feasible on small fragments of villi and offers for the first time the possibility to consider the characterization of gene expression within the structural unit of the human placenta during pregnancy (at the 1st trimester and childbirth)
Read the detailed description
Chorionic villus biopsies are routinely performed between 11SA and 15SA at the Fetal Medicine Unit́ of the Port-Royal Maternity Hospital (CPDPN Cochin) after the patient has signed an information and consent form for the genetic analysis.
The patient will be asked to participate to the VilliRNAseq project and will sign the consent form of the study. After the cytogeneticist observation, a villi fragment will be snap-frozen in liquid nitrogen and stored at -80°C until use. Each patient sampled in the first trimester is followed until the end of the pregnancy. At delivery, cesarean section or vaginal delivery, a placental sample will be snap-frozen in liquid nitrogen and stored at -80°C until use.
Isolation, sorting and encapsidation of nuclei, RNA libraries preparation and sequencing will be carried out using 10x Genomics technology. State-of-the-art computational analyses to decipher trajectories and cell-to-cell communications.
- Conditions
- Pregnancy Related
- Being tested
- Non applicable
- Keywords
- Placenta, Single nuclei RNA-seq, Preeclampsia, Pregnancy outcomes
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non applicableOther
Placental transcriptomic analysis
| Study group | Role | What they receive |
|---|---|---|
| Villi RNASeq | There is only one study group : patients with placental transcriptomic analysis by single nucleus RNA-seq approach Receives: Other: Non applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the cellular transcriptomic trajectory of the human placenta
Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred
Measured: Day 0
Analysis of the cellular transcriptomic trajectory of the human placenta
Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred
Measured: At childbirth
Secondary outcomes (3)
Collection of placental samples
Measured: Day 0
Collection of placental samples
Measured: At childbirth
Identification of early markers of pregnancy complications
Pre-eclampsia, growth retardation in utero, delivery before 37 SA
Measured: Until at Childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start25 Mar 2026
- Primary completionNov 2028 (estimated)
- Study completionFeb 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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Céline MÉHATS, PHD, Study director, Institut National de la Santé Et de la Recherche Médicale, FranceHélène COLLINOT, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427408
- Sponsor's protocol ID
- APHP240045
- Other IDs
- 2022-A02452-41
- Acronym
- VilliRNAseq
- Status last verified
- Mar 2026
- First submitted
- 16 May 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Transcriptomic Trajectory of the Human Placenta During Pregnancy
- ClinicalTrials.gov ID
- NCT06427408
- Acronym / sponsor ID
- VilliRNAseq / APHP240045
- Conditions
- Pregnancy Related
- Keywords
- Placenta, Single nuclei RNA-seq, Preeclampsia, Pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 23 May 2024 (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 single nucleus RNA-seq approach allows the placental transcriptome to be analyzed from nuclei, thus preserving the integrity of placental syncytium. This approach is feasible on small fragments of villi and offers for the first time the possibility to consider the characterization of gene expression within the structural unit of the human placenta during pregnancy (at the 1st trimester and childbirth)
Detailed description
Chorionic villus biopsies are routinely performed between 11SA and 15SA at the Fetal Medicine Unit́ of the Port-Royal Maternity Hospital (CPDPN Cochin) after the patient has signed an information and consent form for the genetic analysis.
The patient will be asked to participate to the VilliRNAseq project and will sign the consent form of the study. After the cytogeneticist observation, a villi fragment will be snap-frozen in liquid nitrogen and stored at -80°C until use. Each patient sampled in the first trimester is followed until the end of the pregnancy. At delivery, cesarean section or vaginal delivery, a placental sample will be snap-frozen in liquid nitrogen and stored at -80°C until use.
Isolation, sorting and encapsidation of nuclei, RNA libraries preparation and sequencing will be carried out using 10x Genomics technology. State-of-the-art computational analyses to decipher trajectories and cell-to-cell communications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Villi RNASeq | – | Other: Non applicableThere is only one study group : patients with placental transcriptomic analysis by single nucleus RNA-seq approach |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women in their pregnancy follow-up at the Maternité Port-Royal-Cochin
Key inclusion criteria (4 listed)
- Age 18 to 50
- Progressive monofoetal pregnancy between 11 and 15 weeks of amenorrhea
- Patient with prenatal medical indication and requesting chorionic villus biopsy with cytogenetic analysis or molecular genetics
- Patient scheduled for delivery at Port-Royal Maternity Hospital
Key exclusion criteria (5 listed)
- Minor patient
- Multiple pregnancy
- Patient's objection
- Without health insurance
- Patient under guardianship or curatorship
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 |
|---|---|---|
| Non applicablePlacental transcriptomic analysis | Other | Villi RNASeq |
Primary outcome
Analysis of the cellular transcriptomic trajectory of the human placenta
Time frame: Day 0
Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred
Analysis of the cellular transcriptomic trajectory of the human placenta
Time frame: At childbirth
Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred
3 secondary outcomes
Collection of placental samples
Time frame: Day 0
Collection of placental samples
Time frame: At childbirth
Identification of early markers of pregnancy complications
Time frame: Until at Childbirth
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 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Céline MÉHATS, PHD study director
Institut National de la Santé Et de la Recherche Médicale, France
Hélène COLLINOT, MD principal investigator
APHP
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 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 5 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 3 Apr 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?
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 Vassilis TSATSARIS, MD PHD (00331 58 41 38 71, vassilis.tsatsaris@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the cellular transcriptomic trajectory of the human placenta (time frame: Day 0). The study lists 2 primary outcomes in all. 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 3 Apr 2026.