About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Singleton pregnancy;
Age > 18 years;
Pregnant women diagnosed with cervical incompetence (via ultrasound criteria) with cervical length <24 mm, before 24 weeks of gestational age, with intact amniotic membranes and absence of uterine contractions;
Pregnant women diagnosed with p-PROM (via clinical criteria and/or with a qualitative immunoassay vaginal test) before 34 weeks of gestational age;
Disqualifiers
Multiple pregnancy;
Patients with contraindications to amniocentesis, including severe bleeding disorders or placenta previa;
Patients with known fetal anomalies incompatible with life;
Patients with sepsis or clinical diagnosis of chorioamnionitis;
Trial design
Single group
Treatments tested in this trial
amniotic fluid collection
Other interventionAmniotic fluid by amniocentesis or by sterile cervical aspiration via the vagina
Treatment groups
Trial outcomes
Primary outcomes
Microbiological analysis of amniotic fluid by next generation analysis
Presence and concentrations of bacteria in amniotic fluid
Sponsors and contacts
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