Longitudinal Study of Gene Expression in the Human Placenta During First-trimester and Full-term Pregnancy at the Single Cell Level

NCT ID: NCT06427408

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-08-31

Brief Summary

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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

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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

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Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Villi RNASeq

There is only one study group : patients with placental transcriptomic analysis by single nucleus RNA-seq approach

Non applicable

Intervention Type OTHER

Placental transcriptomic analysis

Interventions

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Non applicable

Placental transcriptomic analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Minor patient
* Multiple pregnancy
* Patient's objection
* Without health insurance
* Patient under guardianship or curatorship
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Céline MÉHATS, PHD

Role: STUDY_DIRECTOR

Institut National de la Santé Et de la Recherche Médicale, France

Hélène COLLINOT, MD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Maternité Port-Royal, Cochin hospital

Paris, IDF, France

Site Status

Countries

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France

Central Contacts

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Vassilis TSATSARIS, MD PHD

Role: CONTACT

00331 58 41 38 71

Marie BENHAMMANI-GODARD

Role: CONTACT

0033158411190

Facility Contacts

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Hélène COLLINOT, MD

Role: primary

0033 1 58 41 38 19

Other Identifiers

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2022-A02452-41

Identifier Type: OTHER

Identifier Source: secondary_id

APHP240045

Identifier Type: -

Identifier Source: org_study_id

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