PROM, Preterm (Pregnancy), Short Cervix
Conditions
Brief 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.
Interventions
OTHERamniotic fluid collection
Amniotic fluid by amniocentesis or by sterile cervical aspiration via the vagina
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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; * Healthy pregnant women with uncomplicated obstetric history who underwent amniocentesis to exclude chromosomal abnormalities; * Informed consent to participate in the study.
Exclusion criteria
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological analysis of amniotic fluid by next generation analysis | From date of enrollment to the end of pregnancy (up to 9 months) | Presence and concentrations of bacteria in amniotic fluid |
Countries
Italy
Contacts
CONTACTChiara Tersigni
PRINCIPAL_INVESTIGATORChiara Tersigni
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed