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

Pregnancy Related Clinical Trial

— VilliRNAseq  

Official title:

Cellular Transcriptomic Trajectory of the Human Placenta During Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427408
• Other study ID #: APHP240045
• Secondary ID: 2022-A02452-41
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Vassilis TSATSARIS, MD PHD
• Phone: 00331 58 41 38 71
• Email: vassilis.tsatsaris[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• Non applicable
Placental transcriptomic analysis

Locations

Country	Name	City	State
France	Maternité Port-Royal, Cochin hospital	Paris	IDF

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Collection of placental samples		Day 0
Secondary	Collection of placental samples		At childbirth
Secondary	Identification of early markers of pregnancy complications	Pre-eclampsia, growth retardation in utero, delivery before 37 SA	Until at Childbirth