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Can DNA sequencing outsmart standard tests for hidden amniotic infections?

NCT ID NCT07792083

Diagnosis Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This study compares two methods for detecting bacteria in amniotic fluid: standard laboratory cultures and nanopore DNA sequencing. Researchers will collect fluid from pregnant women with a short cervix or preterm rupture of membranes, as well as from healthy pregnant women. The goal is to see whether the DNA method identifies infections more reliably and quickly, which could help guide treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amniotic fluid collection by amniocentesis or vaginal aspiration
What this could lead to
If successful, this could lead to faster and more accurate detection of intra-amniotic infection, enabling earlier treatment and better outcomes for mothers and babies.
What could go wrong
The study is observational and early, so the new method may not prove more reliable than standard cultures. Amniocentesis carries a small risk of complications, and the findings may not apply to all pregnancies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

Fetal Membranes, Premature Rupture preterm premature rupture of the membranes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prom, preterm (pregnancy) Short cervix

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    RECRUITING

    Roma, RM, 00168, Italy

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