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NCT Number: NCT07792083

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

amniotic fluid collection

Other

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

Primary outcomes

  1. Microbiological analysis of amniotic fluid by next generation analysis

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

    Presence and concentrations of bacteria in amniotic fluid

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Tersigni

CONTACT

[email protected]

+390630157546

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: CIPRO

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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