Pregnancy, High RiskPreBirthCervNCT04444206
Prevention of Preterm Birth by Screening of the Consistency Index and Length of the Uterine Cervix in Women With a Single Pregnancy
A study testing Transvaginal ultrasound cervical length screening in people with Pregnancy, High Risk and Preterm Birth, run by University of Campania Luigi Vanvitelli at 1 site 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
- Pregnancy, High Risk, Preterm Birth, Cervix; Pregnancy
- What is being tested?
- Transvaginal ultrasound cervical length screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 25 Apr 2020to 30 Dec 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 18-50 years of age
Who cannot join
- Multiple gestation Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization Labor or cerclage in situ at the time of randomization Women with altered state of consciousness, seriously ill, with mental handicaps;
Trial locations and contacts
1 site in 1 country.
Antonio Schiattarella, MD contact
Italy1 site, 1 recruiting
- Recruiting
University of Campania "Luigi Vanvitelli"
Naples, 80138
Pasquale De Franciscis, Prof, 0039 0815665606, pasquale.defranciscis@unicampania.it
Antonio Schiattarella, MD, aschiattarella@gmail.com
About this study
Official title: Prevention of Preterm Birth by Universal Screening With Ultrasound Measurement of the Consistency Index and Length of the Uterine Cervix in Women With a Single
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.
Other strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix.
However, the predictive value of the research has recently been questioned, as the threat rate from preterms in the low-risk population has not decreased over time. Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its complaints during the three trimesters of pregnancy, an evaluation of the cervical consistency index (CCI) was also proposed, i.e. an ultrasound evaluation of cervical softness.
Read the detailed description
Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its changes during the three trimesters of pregnancy, the evaluation of the cervical consistency index (CCI), or an ultrasound evaluation of cervical softness, was also proposed.
Reduced CCI values correspond to greater compressibility and cervical softness. Studies conducted to study cervical remodeling on animal models suggest an early increase in cervical softness that begins immediately after conception followed by shortening and dilation in the terminal stages of pregnancy so that minimal changes in cervicometry correspond to a significant increase in cervical softness . Therefore the study of the early stages of cervical remodeling, such as cervical softness through the ICC, could allow to identify in a timely manner women with an increased risk of preterm birth.
The purpose of this study is to define and standardize the transvaginal technique to determine the CCI, its reference range and establish its potential predictive use in the threat of preterm birth before 32, 34 and 37 weeks.
The purpose of this study is to verify the hypothesis that the introduction of a universal screening program with TVU CL and CCI measurement, in the three trimesters of pregnancy, may be associated with a predictive ability to deliver preterm higher than current protocols.
- Conditions
- Pregnancy, High Risk, Preterm Birth, Cervix; Pregnancy, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
- Being tested
- Transvaginal ultrasound cervical length screening
- Keywords
- ultrasound
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasound cervical length screeningProcedure or surgery
Cervical lenght and Consistence Cervical Index measurements performed, between 11 and 13 weeks + 6 days, in the , between 19 and 22 weeks and i between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| CL and CCI screening | Experimental | The Cervical lenght (CL) and the Consistence Cervix Index (CCI) will be evaluated by transvaginal ultrasound. CL and CCI measurements will be expected in the first trimester, between 11 and 13 weeks + 6 days, in the second trimester, between 19 and 22 weeks and in the third trimester between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy, in accordance with current national guidelines. Receives: Procedure: Transvaginal ultrasound cervical length screening |
| No CL and CCI screening | No intervention | The investigators collect data of these pregnant women without any additional ultrasound examination |
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 posted23 Jun 2020
- Study start25 Apr 2020
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, High RiskStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, non-pharmacological, non-profit interventional study on women with single pregnancy without a history of previous preterm spontaneous birth. Cervical lenght (CL) and Consistence Cervical Index (CCI) will be assessed by transvaginal ultrasound. CL and CCI measurements will be performed in the first trimester, between 11 and 13 weeks + 6 days, in the second trimester, between 19 and 22 weeks and in the third trimester between 29 and 32 weeks during routine ultrasound examinations for monitoring of pregnancy, in accordance with current national guidelines.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Pasquale De Franciscis, University of Campania Luigi Vanvitelli
- Investigators
- Fabiana Savoia, MD, Principal investigator, University of Campania Luigi VanvitelliMaddalena Morlando, MD, Study chair, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444206
- Sponsor's protocol ID
- 8451
- Acronym
- PreBirthCerv
- Status last verified
- Oct 2020
- First submitted
- 20 Jun 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Preterm Birth by Universal Screening With Ultrasound Measurement of the Consistency Index and Length of the Uterine Cervix in Women With a Single
- ClinicalTrials.gov ID
- NCT04444206
- Acronym / sponsor ID
- PreBirthCerv / 8451
- Conditions
- Pregnancy, High Risk, Preterm Birth, Cervix; Pregnancy, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
- Keywords
- ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Jun 2020 (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.
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.
Other strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix.
However, the predictive value of the research has recently been questioned, as the threat rate from preterms in the low-risk population has not decreased over time. Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its complaints during the three trimesters of pregnancy, an evaluation of the cervical consistency index (CCI) was also proposed, i.e. an ultrasound evaluation of cervical softness.
Detailed description
Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its changes during the three trimesters of pregnancy, the evaluation of the cervical consistency index (CCI), or an ultrasound evaluation of cervical softness, was also proposed.
Reduced CCI values correspond to greater compressibility and cervical softness. Studies conducted to study cervical remodeling on animal models suggest an early increase in cervical softness that begins immediately after conception followed by shortening and dilation in the terminal stages of pregnancy so that minimal changes in cervicometry correspond to a significant increase in cervical softness . Therefore the study of the early stages of cervical remodeling, such as cervical softness through the ICC, could allow to identify in a timely manner women with an increased risk of preterm birth.
The purpose of this study is to define and standardize the transvaginal technique to determine the CCI, its reference range and establish its potential predictive use in the threat of preterm birth before 32, 34 and 37 weeks.
The purpose of this study is to verify the hypothesis that the introduction of a universal screening program with TVU CL and CCI measurement, in the three trimesters of pregnancy, may be associated with a predictive ability to deliver preterm higher than current protocols.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a prospective, non-pharmacological, non-profit interventional study on women with single pregnancy without a history of previous preterm spontaneous birth. Cervical lenght (CL) and Consistence Cervical Index (CCI) will be assessed by transvaginal ultrasound. CL and CCI measurements will be performed in the first trimester, between 11 and 13 weeks + 6 days, in the second trimester, between 19 and 22 weeks and in the third trimester between 29 and 32 weeks during routine ultrasound examinations for monitoring of pregnancy, in accordance with current national guidelines.
| Arm | Type | Receives |
|---|---|---|
| CL and CCI screening | Experimental | Procedure: Transvaginal ultrasound cervical length screeningThe Cervical lenght (CL) and the Consistence Cervix Index (CCI) will be evaluated by transvaginal ultrasound. CL and CCI measurements will be expected in the first trimester, between 11 and 13 weeks + 6 days, in the second trimester, between 19 and 22 weeks and in the third trimester between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy, in accordance with current national guidelines. |
| No CL and CCI screening | No intervention | –The investigators collect data of these pregnant women without any additional ultrasound examination |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Singleton gestations 18-50 years of age
Key exclusion criteria (1 listed)
- Multiple gestation Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization Labor or cerclage in situ at the time of randomization Women with altered state of consciousness, seriously ill, with mental handicaps;
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 screeningCervical lenght and Consistence Cervical Index measurements performed, between 11 and 13 weeks + 6 days, in the , between 19 and 22 weeks and i between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy. | Procedure or surgery | CL and CCI 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 20 Oct 2020.
- 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.
Antonio Schiattarella, MD contact
Fabiana Savoia, MD principal investigator
University of Campania Luigi Vanvitelli
Maddalena Morlando, MD study chair
University of Campania Luigi Vanvitelli
1 site 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 Pregnancy, High Risk and Preterm Birth, run by University of Campania Luigi Vanvitelli 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 1 inclusion and 1 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 20 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pasquale De Franciscis, Prof (0039 0815665606, pasquale.defranciscis@unicampania.it), or a site near the patient. 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 20 Oct 2020.