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

NCT06427408 | Not Yet Recruiting

• 2 other identifiers: APHP2400452022-A02452-41
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 structural unit of the human placenta during pregnancy (at the 1st trimester and childbirth)

Conditions

Pregnancy Related

Keywords

Placenta; Single nuclei RNA-seq; Preeclampsia; Pregnancy outcomes

Outcome Measures

Primary Outcomes (2)

• 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

  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

  At childbirth

Secondary Outcomes (3)

• Collection of placental samples

  Day 0

• Collection of placental samples

  At childbirth

• Identification of early markers of pregnancy complications

  Until at Childbirth

Study Arms (1)

Villi RNASeq

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

Other: Non applicable

Interventions

Non applicable OTHER

Placental transcriptomic analysis

Villi RNASeq

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women in their pregnancy follow-up at the Maternité Port-Royal-Cochin

You may qualify if:

• 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

You may not qualify if:

• Minor patient
• Multiple pregnancy
• Patient's objection
• Without health insurance
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Maternité Port-Royal, Cochin hospital

Paris, IDF, 75014, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Placental tissue

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Céline MÉHATS, PHD

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

  STUDY DIRECTOR

• Hélène COLLINOT, MD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vassilis TSATSARIS, MD PHD

CONTACT

00331 58 41 38 71; vassilis.tsatsaris@aphp.fr

Marie BENHAMMANI-GODARD

CONTACT

0033158411190; marie.godard@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 23, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

FR (1)