Preterm BirthPhase 2NCT02601443
Prevention of Preterm Birth With a Pessary in Triplet
A Phase 2 study testing Cervical Pessary in people with Preterm Birth, run by Federico II University at 1 site in Italy.
Trial summary
The incidence of multiple gestations has increased over the past years, mostly because of increased use of assisted reproductive technologies. Triplet pregnancies are at increased risk of preterm birth (PTB), which is the primary reason for their increased morbidity and mortality compared to singletons. 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
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to Dec 2019
- Phase
- Phase 2
- 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
- Triplet pregnancy (limits the participants to female gender)
- Gestational age at randomization between 20(0) and 22(6)
Who cannot join
- Singleton, twin or higher order than triplets multiple gestation
- Twin twin transfusion syndrome
- Ruptured membranes
- Lethal fetal structural anomaly
- Fetal chromosomal abnormality
- Cerclage in place (or planned placement)
Show all 12Show fewer
- 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.
About this study
The incidence of multiple gestations has increased over the past years, mostly because of increased use of assisted reproductive technologies. Triplet pregnancies are at increased risk of preterm birth (PTB), which is the primary reason for their increased morbidity and mortality compared to singletons. Multiple gestations, including triplets, account for about 3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very low birth weight infants, and nearly 20% of infant mortality.
A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a short CL <25mm before 24weeks, cerclage is associated with significant decreases in PTB and perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the contrary, the effect of cerclage in multiple gesttations has been insufficiently studied, with meta-analysis data showing a possible harm from cerclage compared to controls.
Read more
The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in unselected triplet gestations.
We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU CL <30 mm)
- 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
| Study group | Role | What they receive |
|---|---|---|
| Cervical Pessary | Experimental | Cervical pessary is a medical device used to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early). Early in the pregnancy a round silicone pessary is placed at the opening to the cervix to close it, and then remove late in the pregnancy when the risk of a preterm birth has passed.
Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth. Receives: Device: Cervical Pessary |
| Routine care (watch and wait) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm delivery
Measured: Less than 34 weeks gestation
Secondary outcomes (12)
Gestational age at delivery
Measured: Time of delivery
Birth weight
Measured: Time of delivery
pontaneous preterm birth rates
Measured: Less than 24, 28, 34 and 37 weeks gestation
Spontaneous rupture of membranes
Measured: Less than 34 weeks gestation
Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery
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
Chorioamnionitis
Measured: Time of delivery
Significant adverse maternal effects
Includes heavy bleeding, injury (eg erosion; fistula; etc) to vagina; injury (eg erosion; fistula; etc) to bladder, cervical tear and uterine rupture
Measured: Time of delivery
Intolerance to pessary
Defined as request for removal secondary to discomfort and/or discharge
Measured: Prior to delivery
Preterm delivery
Measured: Less than 24, 28 and 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: never started
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 2
- Primary purpose
- Prevention
- 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
- NCT02601443
- Sponsor's protocol ID
- 213/15
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2015
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
- Prevention of Preterm Birth With a Pessary in Triplet
- ClinicalTrials.gov ID
- NCT02601443
- Acronym / sponsor ID
- 213/15
- Conditions
- Preterm Birth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Nov 2015 (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.
The incidence of multiple gestations has increased over the past years, mostly because of increased use of assisted reproductive technologies. Triplet pregnancies are at increased risk of preterm birth (PTB), which is the primary reason for their increased morbidity and mortality compared to singletons. Multiple gestations, including triplets, account for about 3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very low birth weight infants, and nearly 20% of infant mortality.
A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a short CL <25mm before 24weeks, cerclage is associated with significant decreases in PTB and perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the contrary, the effect of cerclage in multiple gesttations has been insufficiently studied, with meta-analysis data showing a possible harm from cerclage compared to controls.
The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in unselected triplet gestations.
We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU CL <30 mm)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Pessary | Experimental | Device: Cervical PessaryCervical pessary is a medical device used to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early). Early in the pregnancy a round silicone pessary is placed at the opening to the cervix to close it, and then remove late in the pregnancy when the risk of a preterm birth has passed. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth. |
| Routine care (watch and wait) | No intervention | – |
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
- Triplet pregnancy (limits the participants to female gender)
- Gestational age at randomization between 20(0) and 22(6)
Key exclusion criteria (12 listed)
- Singleton, twin or higher order than triplets multiple gestation
- Twin twin transfusion syndrome
- 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 Pessary | Device | Cervical Pessary |
Primary outcome
Preterm delivery
Time frame: Less than 34 weeks gestation
12 secondary outcomes
Gestational age at delivery
Time frame: Time of delivery
Birth weight
Time frame: Time of delivery
pontaneous preterm birth rates
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: rate of cesaran delivery, vaginal delivery and operative vaginal delivery
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
Chorioamnionitis
Time frame: Time of delivery
Significant adverse maternal effects
Time frame: Time of delivery
Intolerance to pessary
Time frame: Prior to delivery
Preterm delivery
Time frame: Less than 24, 28 and 37 weeks
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.
Related trials for Preterm Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
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
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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 2 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 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 delivery (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 19 Nov 2018.