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

Not yet recruiting

• Conditions: Pregnancy Related
• Interventions: Other: Non applicable

• Registration Number: NCT06427408
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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)

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 Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Last Update Submitted: 2024-05-16
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23
• Study Start: 2024-06
• Primary Completion: 2027-02
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Villi RNASeq	Non applicable	There is only one study group : patients with placental transcriptomic analysis by single nucleus RNA-seq approach

Primary Outcome Measures

Name	Time	Method
Analysis of the cellular transcriptomic trajectory of the human placenta	At childbirth	Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred

Secondary Outcome Measures

Name	Time	Method
Collection of placental samples	At childbirth
Identification of early markers of pregnancy complications	Until at Childbirth	Pre-eclampsia, growth retardation in utero, delivery before 37 SA

Trial Locations

Locations (1)

Maternité Port-Royal, Cochin hospital; 🇫🇷 Paris, IDF, France