Longitudinal Study of Gene Expression in the Human Placenta During First-trimester and Full-term Pregnancy at the Single Cell Level
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non applicable.
- Who it may be relevant to
- Registry conditions: Pregnancy Related. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cellular Transcriptomic Trajectory of the Human Placenta During Pregnancy
Overview
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.
Interventions
- Other Non applicable
Placental transcriptomic analysis
Primary outcome measures
- Analysis of the cellular transcriptomic trajectory of the human placenta [Time frame: Day 0]
- Analysis of the cellular transcriptomic trajectory of the human placenta [Time frame: At childbirth]
Secondary outcome measures (3)
- Collection of placental samples [Time frame: Day 0]
- Collection of placental samples [Time frame: At childbirth]
- Identification of early markers of pregnancy complications [Time frame: Until at Childbirth]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Maternité Port-Royal, Cochin hospital — Paris
Identifiers
NCT: NCT06427408 · APHP240045 · 2022-A02452-41