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

NCT07792083 | Recruiting

• 1 other identifier: 8200
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Short Cervix; PROM, Preterm (Pregnancy)

Outcome Measures

Primary Outcomes (1)

• Microbiological analysis of amniotic fluid by next generation analysis

  Presence and concentrations of bacteria in amniotic fluid

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

Study Arms (1)

cases and controls

EXPERIMENTAL

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

Interventions

amniotic fluid collection OTHER

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

cases and controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Chiara Tersigni

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Tersigni

CONTACT

+390630157546; chiara.tersigni@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: August 28, 2026
• Study Start: December 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 28, 2026

Record last verified: 2025-12

Locations

IT (1)