Preterm BirthPhase 3NCT02928302
Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth
A Phase 3 study testing TVU CL screening in people with Preterm Birth, run by Federico II University at 1 site in Italy.
Trial summary
Preterm birth (PTB) is a 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?
- TVU CL screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jul 2018to Dec 2020
- Phase
- Phase 3
- 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 pregnancy (limits the participants to female gender)
- No prior spontaneous preterm delivery, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks
Who cannot join
- Multiple gestation
- Prior spontaneous preterm birth 16-36 6/7 weeks
- Ruptured membranes at time of randomization
- Lethal fetal structural anomaly at time of randomization
- Fetal chromosomal abnormality at time of randomization
- Placenta previa and/or accreta at time of randomization
- Women who already underwent TVU CL measurement during the index pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Preterm birth (PTB) is a 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, we aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy without prior spontaneous PTB
- Conditions
- Preterm Birth
- Being tested
- TVU CL 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.
TVU CL screeningOther
Transvaginal ultrasound cervical length screening
| Study group | Role | What they receive |
|---|---|---|
| TVU CL screening | Experimental | TVU CL screening: single TVU CL at 18 0/7 to 23 6/7 every week Receives: Other: TVU CL screening |
| no screening | No intervention | no TVU CL 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 (12)
Perinatal death
either neonatal death or fetal death
Measured: Between birth and 28 days of age
preterm birth rates
either spontaneous or indicated preterm delivery
Measured: Less than 24, 28, 32, 30, and 34 weeks gestation
admission to neonatal intensive care unit
Measured: time of delivery
Composite perinatal outcome
Includes 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
necrotizing enterocolitis
Defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation
Measured: Between birth and 28 days of age
intraventricular hemorrhage (grade 3 or higher)
IVH
Measured: Between birth and 28 days of age
respiratory distress syndrome
Respiratory distress with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates
Measured: Time of delivery
birth weight
Measured: time of delivery
Length of hospital stay
Days in NICU
Measured: Discharge from hospital
Neonatal death
Measured: Between birth and 28 days of age
gestational age at delivery
Measured: time of delivery
latency
from randomization to delivery
Measured: time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start23 Jul 2018
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: new protocol started 31/18
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 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
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
- NCT02928302
- Sponsor's protocol ID
- 254/16
- Status last verified
- Nov 2018
- First submitted
- 6 Oct 2016
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth
- ClinicalTrials.gov ID
- NCT02928302
- Acronym / sponsor ID
- 254/16
- Conditions
- Preterm Birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: new protocol started 31/18
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 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 a 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, we aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy without prior spontaneous PTB
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVU CL screening | Experimental | Other: TVU CL screeningTVU CL screening: single TVU CL at 18 0/7 to 23 6/7 every week |
| no screening | No intervention | –no TVU CL screening |
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 pregnancy (limits the participants to female gender)
- No prior spontaneous preterm delivery, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks
Key exclusion criteria (7 listed)
- Multiple gestation
- Prior spontaneous preterm birth 16-36 6/7 weeks
- Ruptured membranes at time of randomization
- Lethal fetal structural anomaly at time of randomization
- Fetal chromosomal abnormality at 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 |
|---|---|---|
| TVU CL screeningTransvaginal ultrasound cervical length screening | Other | TVU CL screening |
Primary outcome
preterm birth rate
Time frame: Less than 37 weeks
either spontaneous or indicated preterm delivery
12 secondary outcomes
Perinatal death
Time frame: Between birth and 28 days of age
preterm birth rates
Time frame: Less than 24, 28, 32, 30, and 34 weeks gestation
admission to neonatal intensive care unit
Time frame: time of delivery
Composite perinatal outcome
Time frame: Between birth and 28 days of age
necrotizing enterocolitis
Time frame: Between birth and 28 days of age
intraventricular hemorrhage (grade 3 or higher)
Time frame: Between birth and 28 days of age
respiratory distress syndrome
Time frame: Time of delivery
birth weight
Time frame: time of delivery
Length of hospital stay
Time frame: Discharge from hospital
Neonatal death
Time frame: Between birth and 28 days of age
gestational age at delivery
Time frame: time of delivery
latency
Time frame: time of delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Preterm Birth
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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TVU CL screening in people with Preterm Birth, run by Federico II University 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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 19 Nov 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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 Nov 2018.