## Protocol Section
### Identification Module
**NCT ID:** NCT06427408

**Acronym:** VilliRNAseq

**Brief Title:** 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

#### Organization Study ID Info
**ID:** APHP240045
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**Domain:** France : Ministry of Health
**ID:** 2022-A02452-41
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Institut National de la Santé Et de la Recherche Médicale, France

#### Lead Sponsor

**Class:** OTHER

**Name:** Assistance Publique - Hôpitaux de Paris

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pregnancy Related

**Keywords:**

- Placenta

- Single nuclei RNA-seq

- Preeclampsia

- Pregnancy outcomes

### Design Module

#### Bio Spec

**Description:** Placental tissue

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** There is only one study group : patients with placental transcriptomic analysis by single nucleus RNA-seq approach

**Intervention Names:**

- Other: Non applicable

**Label:** Villi RNASeq

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Villi RNASeq

**Description:** Placental transcriptomic analysis

**Name:** Non applicable

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred

**Measure:** Analysis of the cellular transcriptomic trajectory of the human placenta

**Time Frame:** Day 0

**Description:** Sequencing data will be analysed at the Institut Cochin, cell trajectories will be modelled and intracellular communications will be inferred

**Measure:** Analysis of the cellular transcriptomic trajectory of the human placenta

**Time Frame:** At childbirth

#### Secondary Outcomes

**Measure:** Collection of placental samples

**Time Frame:** Day 0

**Measure:** Collection of placental samples

**Time Frame:** At childbirth

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

**Measure:** Identification of early markers of pregnancy complications

**Time Frame:** Until at Childbirth

### Eligibility Module

**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

**Gender Based:** True

**Gender Description:** Pregnancy

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Women in their pregnancy follow-up at the Maternité Port-Royal-Cochin

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** vassilis.tsatsaris@aphp.fr

**Name:** Vassilis TSATSARIS, MD PHD

**Phone:** 00331 58 41 38 71

**Role:** CONTACT

**Contact 2:**

**Email:** marie.godard@aphp.fr

**Name:** Marie BENHAMMANI-GODARD

**Phone:** 0033158411190

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Name:** Hélène COLLINOT, MD

- **Phone:** 0033 1 58 41 38 19

- **Role:** CONTACT

**Country:** France

**Facility:** Maternité Port-Royal, Cochin hospital

**State:** IDF

**Zip:** 75014

#### Overall Officials

**Official 1:**

**Affiliation:** Institut National de la Santé Et de la Recherche Médicale, France

**Name:** Céline MÉHATS, PHD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** APHP

**Name:** Hélène COLLINOT, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14106

- Name: Pre-Eclampsia

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
