Preterm BirthNCT02923973
Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth
A study testing Transvaginal ultrasound cervical length screening in people with Preterm Birth, run by Federico II University at 2 sites in Italy.
Trial summary
Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. 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?
- Transvaginal ultrasound cervical length screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jun 2018to 1 Mar 2025
- 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
- 18-50 years of age
- Singleton gestations
- Women with prior spontaneous preterm birth, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks
Who cannot join
- multiple gestation
- Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization
- Ballooning of membranes outside the cervix into the vagina at the time of randomization
- Labor or cerclage in situ at the time of randomization
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
University of Pisa
Pisa
Paolo Mannella, MD, 000, paolo.mannella@unipi.it
Paolo Mannella, MD
About this study
Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations.
However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB
- Conditions
- Preterm Birth
- Being tested
- Transvaginal ultrasound 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.
Transvaginal ultrasound cervical length screeningOther
Serial transvaginal ultrasound cervical length scan every week from 16 to 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| TVU CL screening | Experimental | TVU CL screening: serial TVU CL scan from 16 0/7 to 24 6/7 every week, for a total of nine scans Vaginal progesterone 200mg suppository daily from 14 0/7 to 20 6/7 weeks for the history of prior spontaneous preterm delivery Receives: Other: Transvaginal ultrasound cervical length screening |
| No TVU CL screening | No intervention | no screening Vaginal progesterone 200mg suppository daily from 14 0/7 to 20 6/7 weeks for the history of prior spontaneous preterm delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm delivery
Measured: Less than 37 weeks gestation
Secondary outcomes (7)
Gestational age at delivery
Measured: Time of delivery
preterm birth rates
Measured: Less than 24, 28, 34 weeks gestation
Birth weight
Measured: Time of delivery
Low birth weight
Birth weight <2500g
Measured: Time of delivery
Neonatal death
Measured: Between birth and 28 days of age
Composite adverse neonatal outcome
Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death
Measured: Between birth and 28 days of age
Admission to neonatal intensive care unit
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 posted5 Oct 2016 (estimated)
- Study start1 Jun 2018
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa - Prof Paolo Mannella
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923973
- Sponsor's protocol ID
- #30/18
- Status last verified
- Sep 2024
- First submitted
- 3 Oct 2016
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth
- ClinicalTrials.gov ID
- NCT02923973
- Acronym / sponsor ID
- #30/18
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- University of Pisa - Prof Paolo Mannella
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- 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.
Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations.
However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVU CL screening | Experimental | Other: Transvaginal ultrasound cervical length screeningTVU CL screening: serial TVU CL scan from 16 0/7 to 24 6/7 every week, for a total of nine scans Vaginal progesterone 200mg suppository daily from 14 0/7 to 20 6/7 weeks for the history of prior spontaneous preterm delivery |
| No TVU CL screening | No intervention | –no screening Vaginal progesterone 200mg suppository daily from 14 0/7 to 20 6/7 weeks for the history of prior spontaneous preterm delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years of age
- Singleton gestations
- Women with prior spontaneous preterm birth, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks
Key exclusion criteria (4 listed)
- multiple gestation
- Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization
- Ballooning of membranes outside the cervix into the vagina at the time of randomization
- Labor or cerclage in situ 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 |
|---|---|---|
| Transvaginal ultrasound cervical length screeningSerial transvaginal ultrasound cervical length scan every week from 16 to 24 weeks | Other | TVU CL screening |
Primary outcome
Preterm delivery
Time frame: Less than 37 weeks gestation
7 secondary outcomes
Gestational age at delivery
Time frame: Time of delivery
preterm birth rates
Time frame: Less than 24, 28, 34 weeks gestation
Birth weight
Time frame: Time of delivery
Low birth weight
Time frame: Time of delivery
Neonatal death
Time frame: Between birth and 28 days of age
Composite adverse neonatal outcome
Time frame: Between birth and 28 days of age
Admission to neonatal intensive care unit
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 19 Sep 2024.
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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 Transvaginal ultrasound 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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 delivery (time frame: Less than 37 weeks gestation). 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 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.