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Search / Trial NCT06893978

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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 18, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to understand the human placenta, which is the organ that nourishes a baby during pregnancy. Researchers are using something called placental organoids, which are tiny, 3D models of the placenta, to see how different conditions affect its function. The goal is to learn more about issues like preeclampsia (a pregnancy complication), pregnancy loss, and preterm birth, which can impact many women.

To participate in this trial, women need to be between 18 and 74 years old and meet certain criteria. Eligible participants include those with healthy pregnancies who are having a cesarean section, women who have experienced miscarriage, and those diagnosed with preeclampsia or preterm labor. Participants can expect to help advance research that could improve pregnancy outcomes for many women while undergoing routine medical procedures. It's important to note that this study is not yet recruiting participants, so there will be more information available when it begins.

Gender

FEMALE

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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, Lazio, Italy

Patients applied

0 patients applied

Trial Officials

Chiara Tersigni, MD

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported