Clinical trial NCT06427408: Longitudinal Study of Gene Expression in the Human Placenta During First-trimester and Full-term Pregnancy at the Single Cell Level
Official title: Cellular Transcriptomic Trajectory of the Human Placenta During Pregnancy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy Related
Keywords: Placenta
Single nuclei RNA-seq
Preeclampsia
Pregnancy outcomes
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2024-05-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in their pregnancy follow-up at the Maternité Port-Royal-Cochin

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analysis of the cellular transcriptomic trajectory of the human placenta
timeFrame: Day 0
measure: Analysis of the cellular transcriptomic trajectory of the human placenta
timeFrame: At childbirth
Secondary outcomes:
measure: Collection of placental samples
timeFrame: Day 0
measure: Collection of placental samples
timeFrame: At childbirth
measure: Identification of early markers of pregnancy complications
timeFrame: Until at Childbirth
Other outcomes:
Locations:
city: Paris
country: France
facility: Maternité Port-Royal, Cochin hospital
state: IDF
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Céline MÉHATS, PHD
role: STUDY_DIRECTOR
affiliation: APHP
name: Hélène COLLINOT, MD
role: PRINCIPAL_INVESTIGATOR
References: