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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, Lazio, Italy
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