Preterm BirthPhase 3NCT02716922
Cerclage for Singletons With Short Cervix Without Prior Preterm Birth
A Phase 3 study testing Cervical cerclage in people with Preterm Birth, run by Federico II University at 1 site in Italy.
Trial summary
Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. 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 cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to Mar 2019
- 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
- Singleton pregnancy (limits the participants to female gender)
- Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
- 18-50 years of age
Who cannot join
- Multiple gestation
- Prior spontaneous preterm birth 16-36 6/7 weeks
- Ruptured membranes
- Lethal fetal structural anomaly
- Fetal chromosomal abnormality
- Pessary in place (or planned placement)
Show all 11Show fewer
- Vaginal bleeding
- Suspicion of chorioamnionitis
- Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
- Painful regular uterine contractions
- Placenta previa
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gabriele Saccone
Naples, 80129
Gabriele Saccone, 3394685179, gabriele.saccone@libero.it
About this study
Official title: Cervical Cerclage for Singleton Gestations With Short Cervix and Without Prior Preterm Birth
Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size
- Conditions
- Preterm Birth
- Being tested
- Cervical cerclage
- 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 cerclageProcedure or surgery
Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups)
| Study group | Role | What they receive |
|---|---|---|
| Cervical cerclage | Experimental | Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Receives: Procedure: Cervical cerclage |
| No intervention | No intervention | No cerclage Women randomized to not receive cerclage represent the control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous preterm birth rates <34weeks
Measured: Less than 34 weeks gestation
Secondary outcomes (13)
Spontaneous preterm birth rates <37, <28 and <24 weeks
Measured: Less than 24, 28, and 37 weeks gestation
Type of delivery
Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery
Measured: Time of delivery
Spontaneous rupture of membranes
Ruptured membranes <34 weeks
Measured: Less than 34 weeks gestation
Neonatal death
Measured: Between birth and 28 days of age
birth weight
Measured: Time of delivery
Chorioamnionitis
histologic diagnosis of chorioamnionitis
Measured: Time of delivery
necrotizing enterocolitis
Measured: Between birth and 28 days of age
intraventricular hemorrhage
intraventricular hemorrhage (grade 3 or higher)
Measured: Between birth and 28 days of age
respiratory distress syndrome
Measured: Between birth and 28 days of age
bronchopulmonary dysplasia
Measured: Between birth and 28 days of age
blood-culture proven sepsis
Measured: Between birth and 28 days of age
neonatal mortality
death of a live-born baby within the first 28 days of life
Measured: Between birth and 28 days of age
perinatal death
either fetal mortality or neonatal mortality
Measured: Until 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 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2018 (estimated)
- Study completionMar 2019 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT02716922
- Sponsor's protocol ID
- 33/2016
- Status last verified
- Mar 2016
- First submitted
- 6 Mar 2016
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cerclage for Singleton Gestations With Short Cervix and Without Prior Preterm Birth
- ClinicalTrials.gov ID
- NCT02716922
- Acronym / sponsor ID
- 33/2016
- Conditions
- Preterm Birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 23 Mar 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 remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical cerclage | Experimental | Procedure: Cervical cerclageWomen randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix |
| No intervention | No intervention | –No cerclage Women randomized to not receive cerclage represent the control arm |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy (limits the participants to female gender)
- Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
- 18-50 years of age
Key exclusion criteria (11 listed)
- Multiple gestation
- Prior spontaneous preterm birth 16-36 6/7 weeks
- Ruptured membranes
- Lethal fetal structural anomaly
- Fetal chromosomal abnormality
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 cerclageCerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups) | Procedure or surgery | Cervical cerclage |
Primary outcome
Spontaneous preterm birth rates <34weeks
Time frame: Less than 34 weeks gestation
13 secondary outcomes
Spontaneous preterm birth rates <37, <28 and <24 weeks
Time frame: Less than 24, 28, and 37 weeks gestation
Type of delivery
Time frame: Time of delivery
Spontaneous rupture of membranes
Time frame: Less than 34 weeks gestation
Neonatal death
Time frame: Between birth and 28 days of age
birth weight
Time frame: Time of delivery
Chorioamnionitis
Time frame: Time of delivery
necrotizing enterocolitis
Time frame: Between birth and 28 days of age
intraventricular hemorrhage
Time frame: Between birth and 28 days of age
respiratory distress syndrome
Time frame: Between birth and 28 days of age
bronchopulmonary dysplasia
Time frame: Between birth and 28 days of age
blood-culture proven sepsis
Time frame: Between birth and 28 days of age
neonatal mortality
Time frame: Between birth and 28 days of age
perinatal death
Time frame: Until 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 23 Mar 2016.
- 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.
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 Cervical cerclage 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 11 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 23 Mar 2016. 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?
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?
Spontaneous preterm birth rates <34weeks (time frame: Less than 34 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 23 Mar 2016.