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NCT Number: NCT06427408

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

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)

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Maternité Port-Royal, Cochin hospital

Paris, IDF, 75014, France

Location status: Recruiting

Location contact

Hélène COLLINOT, MD

CONTACT

0033 1 58 41 38 19

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non applicable

Other

Placental transcriptomic analysis

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Collection of placental samples

    Time frame: Day 0

  2. Collection of placental samples

    Time frame: At childbirth

  3. Identification of early markers of pregnancy complications

    Time frame: Until at Childbirth

    Pre-eclampsia, growth retardation in utero, delivery before 37 SA

Study contacts

Contact information is provided by the study sponsor or research team.

Marie BENHAMMANI-GODARD

CONTACT

[email protected]

0033158411190

Vassilis TSATSARIS, MD PHD

CONTACT

[email protected]

00331 58 41 38 71

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Cellular Transcriptomic Trajectory of the Human Placenta During Pregnancy

Acronym: VilliRNAseq

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 23, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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