Microbiological and Biochemical Profiling of Amniotic Fluid in Women With Short Cervix or Premature Rupture of Membranes
NCT07792083 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-08-28
Summary
This study aims at assessing the efficacy, reliability, and clinical impact of Amniotic Fluid analysis by Nanopore DNA sequencing compared to the standard bacterial cultures in detecting intra-amniotic/inflammation in patients with short cervix or premature rupture of membranes.
Conditions
- Short Cervix
- PROM, Preterm (Pregnancy)
Interventions
- OTHER
-
amniotic fluid collection
Amniotic fluid by amniocentesis or by sterile cervical aspiration via the vagina
Sponsors & Collaborators
-
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
lead OTHER
Principal Investigators
-
Chiara Tersigni · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-12-23
- Primary Completion
- 2026-12-31
- Completion
- 2030-12-31
Countries
- Italy
Study Locations
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