Not Yet RecruitingNot Applicable

Placental Organoids Development: Application in the Study of the Human Reproduction Pathophysiology.

Italy20 participantsStarted 2025-05-20

Plain-language summary

Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women with uncomplicated normal term pregnancy undergoing elective cesarean section for previous uterine surgery or breech presentation of the fetus; * Patients with retained abortion and history of recurrent abortion sine causa at the end of the work-up of investigations performed according to ESHRE guidelines, undergoing revision of the uterine cavity; * Patients diagnosed with preeclampsia, defined in accordance with the definitions of ISSHP, undergoing cesarean section; * Patients with preterm onset, before 37 weeks gestational age, of spontaneous labor, undergoing cesarean section in labor for low weight or abnormal fetal presentation. Exclusion Criteria: * Age \<18 years; * Chronic infection with HIV or HCV; * Ongoing malignant neoplasms; * Multiple pregnancies; * Inability to provide informed informed consent.

What they're measuring

Development of placental 3D organoid model

Timeframe: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.

Characterization of placental 3D organoid model

Timeframe: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.

Viability of Placental Organoids

Timeframe: From date of caesarean section until the development of placental organoids, until 36 months

Trial details

NCT IDNCT06893978

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-11

Contact for this trial

Chiara Tersigni

+390630157546 chiara.tersigni@policlinicogemelli.it

View on ClinicalTrials.gov More Preeclampsia trials

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Development of placental 3D organoid model

Timeframe: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.

Characterization of placental 3D organoid model

Timeframe: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.

Viability of Placental Organoids

Timeframe: From date of caesarean section until the development of placental organoids, until 36 months