Short CervixCIPRONCT07792083
Microbiological and Biochemical Profiling of Amniotic Fluid in Women With Short Cervix or Premature Rupture of Membranes
A study testing amniotic fluid collection in people with Short Cervix and PROM, Preterm (Pregnancy), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Short Cervix, PROM, Preterm (Pregnancy)
- What is being tested?
- amniotic fluid collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 23 Dec 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00168
About this study
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)
- Being tested
- amniotic fluid collection
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amniotic fluid collectionOther
Amniotic fluid by amniocentesis or by sterile cervical aspiration via the vagina
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: amniotic fluid collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological analysis of amniotic fluid by next generation analysis
Presence and concentrations of bacteria in amniotic fluid
Measured: From date of enrollment to the end of pregnancy (up to 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start23 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short CervixStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiara Tersigni, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792083
- Sponsor's protocol ID
- 8200
- Acronym
- CIPRO
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological and Biochemical Profiling of Amniotic Fluid in Women With Short Cervix or Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT07792083
- Acronym / sponsor ID
- CIPRO / 8200
- Conditions
- Short Cervix, PROM, Preterm (Pregnancy)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases and controls | Experimental | Other: amniotic fluid collectionWomen 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amniotic fluid collectionAmniotic fluid by amniocentesis or by sterile cervical aspiration via the vagina | Other | cases and controls |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiara Tersigni principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amniotic fluid collection in people with Short Cervix and PROM, Preterm (Pregnancy), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Tersigni (+390630157546, chiara.tersigni@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological analysis of amniotic fluid by next generation analysis (time frame: From date of enrollment to the end of pregnancy (up to 9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.