Microbiological and Biochemical Profiling of Amniotic Fluid in Women With Short Cervix or Premature Rupture of Membranes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • amniotic fluid collection

    Other intervention

    Amniotic fluid by amniocentesis or by sterile cervical aspiration via the vagina

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: cases and controlsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Microbiological analysis of amniotic fluid by next generation analysis

Presence and concentrations of bacteria in amniotic fluid

Time frame
From date of enrollment to the end of pregnancy (up to 9 months)

Secondary outcomes

Other outcomes

Sponsors and contacts

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