Status:
ACTIVE_NOT_RECRUITING
The Placental Secretome as a Therapeutic Tool to Prevent Inflammation-induced Preterm Birth
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Preterm Birth
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Preterm birth complicates 10% of all pregnancies and is the leading cause of perinatal morbidity and mortality worldwide. Intra-amniotic inflammation (IAI) and chorioamnionitis are well-established ca...
Detailed Description
Preterm birth complicates 10% of all pregnancies and is the leading cause of perinatal morbidity and mortality worldwide. Among all PTB cases, 70% occur spontaneously (SPTB), while the remaining 30% a...
Eligibility Criteria
Inclusion
- Full-term uncomplicated pregnancy, without any medical conditions or ongoing pharmacological treatment (control group).
- Pregnancy complicated by spontaneous preterm birth (gestational age 24-32 weeks).
- Pregnancy complicated by medically indicated preterm birth (gestational age 24-32 weeks).
Exclusion
- Age \<18 years
- Chronic infections (HIV or HCV)
- Cancer
- Multiple pregnancy
- Inability to provide informed consent
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06891508
Start Date
March 11 2025
End Date
March 20 2028
Last Update
March 24 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica
Rome, Lazio, Italy, 00168