Clinical trial NCT06893978: Placental Organoids Development: Application in the Study of the Human Reproduction Pathophysiology.
Official title: Placental Organoids Development: Application in the Study of the Human Reproduction Pathophysiology.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Preeclampsia
Pregnancy Loss
Preterm Birth
Healthy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with normal pregnancy (n=5) or complicated by:

* miscarriage (n=5);
* preeclampsia (n=5);
* preterm delivery (n=5); afferent to the U.O.C. of Obstetrics of the Agostino Policlinico Universitario Agostino Gemelli IRCCS of Rome.

Brief 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.

Detailed description: Placental organoids represent an in vitro 3D reconstruction model of the human placenta and of its complex cellular organization. Placental organoid model can be used in the study of placental pathophysiology. In in particular, it provides a personalized model for sartorial in vitro evaluation of personalized therapeutic efficacy of different pharmacological therapies. In particular, with placental organoid it is possible to evaluate the pharmacological effect in terms of placentation, gene expression, protein synthesis and placental secretomics.

Eligibility criteria: 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.

Primary outcomes:
measure: Development of placental 3D organoid model
timeFrame: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
measure: Characterization of placental 3D organoid model
timeFrame: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.
measure: Viability of Placental Organoids
timeFrame: From date of caesarean section until the development of placental organoids, until 36 months
Secondary outcomes:
measure: Gene Expression in Placental Organoids
timeFrame: From date of caesarean section until the development of placental organoids, until 36 months
measure: Secretome Analysis of Placental Organoids
timeFrame: From date of caesarean section until the development of placental organoids, until 36 months
measure: Proliferative Capacity of Placental Organoids
timeFrame: From date of caesarean section until the development of placental organoids, until 36 months
measure: Growth capacity of placental organoids
timeFrame: From date of caesarean section until the development of placental organoids, until 36 months
measure: Protein expression in placental organoids
timeFrame: From date of caesarean section until the development of placental organoids, until 36 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Chiara Tersigni, MD
role: PRINCIPAL_INVESTIGATOR
References: