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Not yet recruiting NCT06893978

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

— Observational Preeclampsia Pregnancy Loss Preterm Birth Healthy

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: Placenta organoids treatment.
Who it may be relevant to
Registry conditions: Preeclampsia, Pregnancy Loss, Preterm Birth, Healthy. Basic parameters: from 18 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
Italy
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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Overview

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.

Interventions

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

Primary outcome measures

  • Development of placental 3D organoid model [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 [Time frame: From the date of caesarean section until the development of placental organoids, assessed up to 36 months.]
  • Viability of Placental Organoids [Time frame: From date of caesarean section until the development of placental organoids, until 36 months]
Secondary outcome measures (5)
  • Gene Expression in Placental Organoids [Time frame: From date of caesarean section until the development of placental organoids, until 36 months]
  • Secretome Analysis of Placental Organoids [Time frame: From date of caesarean section until the development of placental organoids, until 36 months]
  • Proliferative Capacity of Placental Organoids [Time frame: From date of caesarean section until the development of placental organoids, until 36 months]
  • Growth capacity of placental organoids [Time frame: From date of caesarean section until the development of placental organoids, until 36 months]
  • Protein expression in placental organoids [Time frame: From date of caesarean section until the development of placental organoids, until 36 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetric — Rome

Identifiers

NCT: NCT06893978 · 7203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗