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

ConditionsPreeclampsia Pregnancy Loss Preterm Birth Healthy

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age <18 years;

Chronic infection with HIV or HCV;

Ongoing malignant neoplasms;

Multiple pregnancies;

Trial 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.

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

Placenta organoids treatment
Drug
Placenta organoids in vitro treatment with heparin, aspirin, IVIG, filgrastim and metformin

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Development of placental 3D organoid model

Morphological characteristics of placental 3D organoids successfully developed from placentas obtained from full-term physiological pregnancies and pathological conditions (abortion, preeclampsia, preterm delivery). Assessment Parameters: Organoid formation efficiency (%)

Time frame

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

Characterization of placental 3D organoid model

Assessment of cell viability (live/dead staining)

Time frame

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

Viability of Placental Organoids

Measurement of cell proliferation rate in normal and pathological placental organoids before and after anticoagulant, anti-inflammatory, and immunomodulatory treatments (heparin, aspirin, metformin, IVIg, filgrastim). Assessment Parameters: Cell viability (live/dead staining)

Time frame