An interventional study of amniotic fluid collection in Short Cervix and PROM, Preterm (Pregnancy), sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
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.
100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 59 interventional studies indexed under Fetal Membranes, Premature Rupture.
Browse Fetal Membranes, Premature Rupture studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with diagnosis of short cervix before 24 weeks of gestational age undergone to amniocentesis (cases group 1), women with premature rupture of membranes undergone to amniotic fluid collection by sterile cervical aspiration via the vagina (cases group 2) and healthy women with an uncomplicated obstetric history undergoing amniocentis for genetic diagnosis (controls)
Other: amniotic fluid collection
Amniotic fluid by amniocentesis or by sterile cervical aspiration via the vagina
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)
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
Of 23 interventional studies with no phase under Fetal Membranes, Premature Rupture, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 62. This study's planned 12 months is below that.
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