Preterm BirthNCT02708264
Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?
A study testing Cervical pessary in people with Preterm Birth, run by Federico II University at 1 site in Italy.
Trial summary
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. 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 pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2016to Mar 2021
- 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
- Twin pregnancy (limits the participants to female gender)
- Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
Who cannot join
- Singleton or higher order than twins multiple gestation
- Monoamniotic twins
- Twin twin transfusion syndrome
- Ruptured membranes
- Lethal fetal structural anomaly
- Fetal chromosomal abnormality
Show all 13Show fewer
- Cerclage in place (or planned placement)
- Vaginal bleeding
- Suspicion of chorioamnionitis
- Ballooning of membranes outside the cervix into the vagina
- Painful regular uterine contractions
- Labor
- 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: Pessary in Prevention of Preterm Birth for Women With Twin Pregnancies and Short Cervical Length
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins.
The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.
- Conditions
- Preterm Birth
- Being tested
- Cervical pessary
- 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 pessaryDevice
The cervical pessary is a silicone device that has been used to prevent SPTB
| Study group | Role | What they receive |
|---|---|---|
| Cervical Pessary | Experimental | The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated) Receives: Device: Cervical pessary |
| No intervention | No intervention | No pessary No pessary will be used. Subjects will receive standard obstetrical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Preterm delivery <34 weeks
Measured: Less than 34 weeks gestation
Secondary outcomes (8)
Gestational age
Measured: Time of delivery
Birth weight
Measured: Time of delivery
Spontaneous preterm birth rates <37, <28 and <24 weeks
Measured: Less than 24, 28, 34 and 37 weeks gestation
Spontaneous rupture of membranes
Rupture of membranes <34 weeks
Measured: Less than 34 weeks gestation
Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery)
cesarean delivery, operative vaginal delivery, spontaneous vaginal delivery
Measured: Time of delivery
Neonatal death
Measured: Between birth and 28 days of age
Composite perinatal 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
Maternal side effects
Measured: Maternal side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completionJan 2021 (estimated)
- Study completionMar 2021 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 242 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
- NCT02708264
- Sponsor's protocol ID
- 214/2015
- Status last verified
- Nov 2018
- First submitted
- 6 Mar 2016
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pessary in Prevention of Preterm Birth for Women With Twin Pregnancies and Short Cervical Length
- ClinicalTrials.gov ID
- NCT02708264
- Acronym / sponsor ID
- 214/2015
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 15 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.
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins.
The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Pessary | Experimental | Device: Cervical pessaryThe cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated) |
| No intervention | No intervention | –No pessary No pessary will be used. Subjects will receive standard obstetrical management |
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
- Twin pregnancy (limits the participants to female gender)
- Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
Key exclusion criteria (13 listed)
- Singleton or higher order than twins multiple gestation
- Monoamniotic twins
- Twin twin transfusion syndrome
- Ruptured membranes
- Lethal fetal structural anomaly
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 pessaryThe cervical pessary is a silicone device that has been used to prevent SPTB | Device | Cervical Pessary |
Primary outcome
Spontaneous Preterm delivery <34 weeks
Time frame: Less than 34 weeks gestation
8 secondary outcomes
Gestational age
Time frame: Time of delivery
Birth weight
Time frame: Time of delivery
Spontaneous preterm birth rates <37, <28 and <24 weeks
Time frame: Less than 24, 28, 34 and 37 weeks gestation
Spontaneous rupture of membranes
Time frame: Less than 34 weeks gestation
Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery)
Time frame: Time of delivery
Neonatal death
Time frame: Between birth and 28 days of age
Composite perinatal outcome
Time frame: Between birth and 28 days of age
Maternal side effects
Time frame: Maternal side effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- 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 study testing Cervical pessary 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 13 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 16 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.
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 delivery <34 weeks (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 16 Nov 2018.