Amniotic Fluid DNA sequencing to detect infection in women with short cervix or PROM

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study collects amniotic fluid from eligible pregnant women to compare nanopore DNA sequencing with conventional cultures for detecting intra-amniotic infection or inflammation. Participants include women with cervical shortening, prior to 24 weeks, or p-PROM before 34 weeks, as well as healthy controls undergoing amniocentesis. The primary aim is to evaluate reliability, clinical impact, and potential benefits of the sequencing approach. Findings may influence how intra-amniotic infection is diagnosed in at-risk pregnancies. No results are provided here as this is an information-only summary.

Why it matters

Who can join: the full rules

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;

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS
  Roma, Rm, Italy Recruiting

Study contacts

• Principal investigator: Chiara Tersigni — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Chiara Tersigni
• Email: chiara.tersigni@policlinicogemelli.it
• Phone: +390630157546

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.