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

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)

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Non applicable

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Marie Benhammani-Godard; Phone Number: 0033158411190; Email: marie.godard@aphp.fr
• Study Contact Backup: Name: Vassilis TSATSARIS, MD PHD; Phone Number: 00331 58 41 38 71; Email: vassilis.tsatsaris@aphp.fr

Study Locations

• France
  • IDF
    • Paris, IDF, France, 75014
      • Recruiting
      • Maternité Port-Royal, Cochin hospital
      • Contact: Hélène COLLINOT, MD; Phone Number: 0033 1 58 41 38 19

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Villi RNASeq; There is only one study group : patients with placental transcriptomic analysis by single nucleus RNA-seq approach	Other: Non applicable; Placental transcriptomic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of placental samples		Day 0
Collection of placental samples		At childbirth
Identification of early markers of pregnancy complications	Pre-eclampsia, growth retardation in utero, delivery before 37 SA	Until at Childbirth

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; URC-CIC Paris Descartes Necker Cochin
• Investigators: Study Director: Céline MÉHATS, PHD, Institut National de la Santé Et de la Recherche Médicale, France; Principal Investigator: Hélène COLLINOT, MD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Preeclampsia; Pregnancy outcomes; Placenta; Single nuclei RNA-seq
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: APHP240045; 2022-A02452-41 (Other Identifier: France : Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No