Preterm BirthNCT03591042
Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth
A study testing cervical length screening in people with Preterm Birth, run by Federico II University at 2 sites in Italy.
Trial summary
This is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- cervical length screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,334 participants
- Where
- 2 sitesItaly
- Study dates
- 21 Jul 2018to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton gestations
- No prior SPTB
Who cannot join
- Multiple gestations
- History of SPTB in a prior pregnancy
- Rupture of membranes at the time of randomization
- Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
- Fetal death at the time of randomization
- Cerclage in situ at the time of randomization
Show all 9Show fewer
- Pessary in situ at the time of randomization
- Vaginal bleeding at the time of randomization
- Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Gabriele Saccone
Naples, 80100
Gabriele Saccone, 0817461111, gabriele.saccone.1990@gmail.com
- Recruiting
Seconda Università di Napoli Luigi Vanvitelli
Naples
Maddalena Morlando, 0817461111, madmorlando@gmail.com
Maddalena Morlando, MD
About this study
Official title: Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth: a Randomized Controlled Trial
This is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. Women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. The cervical length will be measured by operators with certification of competence in the technique.
- Conditions
- Preterm Birth
- Being tested
- cervical length screening
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical length screeningDiagnostic test
transvaginal ultrasound cervical length
| Study group | Role | What they receive |
|---|---|---|
| cervical length screening | Experimental | cervical length screening Receives: Diagnostic Test: cervical length screening |
| no screening | No intervention | no screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
preterm birth rate
either spontaneous or indicated preterm delivery
Measured: Less than 37 weeks
Secondary outcomes (6)
preterm birth rate
either spontaneous or indicated preterm delivery
Measured: ess than 24, 28, 32, 30, and 34 weeks gestation
admission to neonatal intensive care unit
Measured: time of delivery
neonatal death
Measured: Between birth and 28 days of age
birth weight
weight of the baby at the time of delivery
Measured: time of delivery
Composite of adverse perinatal outcomes
Number of neonates who will have at least one of the following: necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) (grade 3 or higher), respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), retinopathy (ROP), blood-culture proven sepsis and neonatal death
Measured: Between birth and 28 days of age
perinatal death
either fetal or neonatal mortality
Measured: Between birth and 28 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start21 Jul 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591042
- Sponsor's protocol ID
- 31/18
- Status last verified
- Apr 2021
- First submitted
- 5 Jul 2018
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saccone G, Maruotti GM, Morlando M, Visentin S, De Angelis C, Sarno L, Cosmi E, Torcia F, Costanzi F, Gragnano E, Bartolini G, La Verde M, Borelli F, Savoia F, Schiattarella A, De Franciscis P, Locci M, Guida M; Italian Preterm Birth Prevention (IPP) Working Group. Randomized trial of screening for preterm birth in low-risk women - the preterm birth screening study. Am J Obstet Gynecol MFM. 2024 May;6(5S):101267. doi: 10.1016/j.ajogmf.2023.101267. Epub 2024 Feb 19.
PubMed 38642994
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03591042
- Acronym / sponsor ID
- 31/18
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,334 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 21 Jul 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 18 Jul 2018 (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 is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. Women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. The cervical length will be measured by operators with certification of competence in the technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervical length screening | Experimental | Diagnostic Test: cervical length screeningcervical length screening |
| no screening | No intervention | –no screening |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Singleton gestations
- No prior SPTB
Key exclusion criteria (9 listed)
- Multiple gestations
- History of SPTB in a prior pregnancy
- Rupture of membranes at the time of randomization
- Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
- Fetal death at the time of randomization
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 |
|---|---|---|
| cervical length screeningtransvaginal ultrasound cervical length | Diagnostic test | cervical length screening |
Primary outcome
preterm birth rate
Time frame: Less than 37 weeks
either spontaneous or indicated preterm delivery
6 secondary outcomes
preterm birth rate
Time frame: ess than 24, 28, 32, 30, and 34 weeks gestation
admission to neonatal intensive care unit
Time frame: time of delivery
neonatal death
Time frame: Between birth and 28 days of age
birth weight
Time frame: time of delivery
Composite of adverse perinatal outcomes
Time frame: Between birth and 28 days of age
perinatal death
Time frame: Between birth and 28 days of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Derived from this study: PubMed 38642994Saccone G, Maruotti GM, Morlando M, Visentin S, De Angelis C, Sarno L, Cosmi E, Torcia F, Costanzi F, Gragnano E, Bartolini G, La Verde M, Borelli F, Savoia F, Schiattarella A, De Franciscis P, Locci M, Guida M; Italian Preterm Birth Prevention (IPP) Working Group. Randomized trial of screening for preterm birth in low-risk women - the preterm birth screening study. Am J Obstet Gynecol MFM. 2024 May;6(5S):101267. doi: 10.1016/j.ajogmf.2023.101267. Epub 2024 Feb 19.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical length screening in people with Preterm Birth, run by Federico II University at 2 sites 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preterm birth rate (time frame: Less than 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03591042, which also lists 1 linked publication.
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 6 Apr 2021; AzTrials last refreshed its copy on 1 Nov 2026.