Preterm BirthPhase 3NCT02716909
Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
A Phase 3 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. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor 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
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to Jul 2017
- 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)
- Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation
Who cannot join
- Multiple gestation
- Prior spontaneous preterm birth 16-36 6/7 weeks
- Ruptured membranes
- Lethal fetal structural anomaly
- Fetal chromosomal abnormality
- Cerclage 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.
About this study
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.
The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of 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 Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
| 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 37th 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 birth (SPTB) <34 weeks
Spontaneous preterm delivery less than 34 weeks of gestation
Measured: Less than 34 weeks gestation
Secondary outcomes (14)
SPTB <37w
Measured: Less than 37 weeks gestation
SPTB <32w
Measured: Less than 32 weeks gestation
SPTB <28w
Measured: Less than 32 weeks gestation
Gestational age at delivery
Measured: Time of delivery
Latency
interval from randomization to delivery in days
Measured: time of delivery
preterm premature rupture of membranes
Measured: Less than 34 weeks gestation
Type of delivery
Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery
Measured: time of delivery
Maternal side effects
Vaginal discharge, bacterial vaginosis
Measured: Time of delivery
Birth weight
Measured: Time of delivery
Neonatal death
Measured: Between birth and 28 days of age
perinatal death
either fetal mortality or neonatal death
Measured: fetal death after 20 weeks
Composite adverse 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
Chorioamnionitis
Measured: Time of delivery
Adminssion 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 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT02716909
- Sponsor's protocol ID
- 213/2015
- Status last verified
- Jun 2018
- First submitted
- 6 Mar 2016
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Saccone G, Maruotti GM, Giudicepietro A, Martinelli P; Italian Preterm Birth Prevention (IPP) Working Group. Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2317-2324. doi: 10.1001/jama.2017.18956.
PubMed 29260226
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
- ClinicalTrials.gov ID
- NCT02716909
- Acronym / sponsor ID
- 213/2015
- Conditions
- Preterm Birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- 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.
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.
The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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 37th 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
- Singleton pregnancy (limits the participants to female gender)
- Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation
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 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 37th week of pregnancy (or earlier, if indicated) | Device | Cervical Pessary |
Primary outcome
Spontaneous preterm birth (SPTB) <34 weeks
Time frame: Less than 34 weeks gestation
Spontaneous preterm delivery less than 34 weeks of gestation
14 secondary outcomes
SPTB <37w
Time frame: Less than 37 weeks gestation
SPTB <32w
Time frame: Less than 32 weeks gestation
SPTB <28w
Time frame: Less than 32 weeks gestation
Gestational age at delivery
Time frame: Time of delivery
Latency
Time frame: time of delivery
preterm premature rupture of membranes
Time frame: Less than 34 weeks gestation
Type of delivery
Time frame: time of delivery
Maternal side effects
Time frame: Time of delivery
Birth weight
Time frame: Time of delivery
Neonatal death
Time frame: Between birth and 28 days of age
perinatal death
Time frame: fetal death after 20 weeks
Composite adverse perinatal outcome
Time frame: Between birth and 28 days of age
Chorioamnionitis
Time frame: Time of delivery
Adminssion to neonatal intensive care unit
Time frame: Between birth and 28 days of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Derived from this study: PubMed 29260226Saccone G, Maruotti GM, Giudicepietro A, Martinelli P; Italian Preterm Birth Prevention (IPP) Working Group. Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2317-2324. doi: 10.1001/jama.2017.18956.
- 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.
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 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 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: finished, as of the sponsor's last update on 18 Jun 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spontaneous preterm birth (SPTB) <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?
On the ClinicalTrials.gov record for NCT02716909, which also lists 1 linked publication.
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 18 Jun 2018.