Preterm BirthNCT03543475
Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor
A study testing arabin pessary and no pessary in people with Preterm Birth, run by Federico II University at 1 site in Italy.
Trial summary
Preterm birth (PTB) is a 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. 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?
- arabin pessary and no pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 1 Nov 2019
- 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
- Diagnosis of arrested PTL
- 18-50 years of age
- TVU CL ≤25mm at the time of randomization
Who cannot join
- Multiple gestations
- Rupture of membranes at the time of randomization
- Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
- Fetal death at the time of randomization
- Cerclage in situ at the time of randomization
- Pessary in situ at the time of randomization
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- Vaginal bleeding at the time of randomization
- Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years
- Placenta previa and/or accreta
- Ballooning of membranes outside the cervix into the vaginal or TVU CL = 0mm at the time of randomization
- Painful and regular uterine contractions at the time of randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor: a Randomized Controlled Trial
Preterm birth (PTB) is a 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.
Different strategies have been studied for prevention of spontaneous PTB (SPTB) in randomized controlled trials (RCTs), including progesterone, cerclage, cervical pessary, as well as lifestyle modification, such as smoking cessation, diet, aerobic exercise, and nutritional supplements. Most successful effort to reduce the incidence of SPTB have focused on asympatomatic women with risk factors, such as prior SPTB or short cervix. However, most SPTB occur in symptomatic women, i.e. women with preterm labor (PTL). Women with arrested PTL are at increased risk of SPTB.
Read more
The cervical pessary is a silicone device that has been used to prevent SPTB. The leading hypotheses for its mechanisms are two: that the pessary helps to keep the cervix closed, and that the pessary changes the inclination of the cervical canal so that the pregnancy weight is not directly above the internal os.
The aim of the study is to assess the efficacy of pessary in reducing preterm birth in women with arrested preterm labor
- Conditions
- Preterm Birth
- Being tested
- arabin pessary, no 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.
arabin pessaryDevice
arabin pessary: silicon device
no pessaryDevice
control group
| Study group | Role | What they receive |
|---|---|---|
| Pessary | Experimental | Silicon device applied on the cervix Receives: Device: arabin pessary |
| No Pessary | Active comparator | standard care, no pessary Receives: Device: no pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-term Birth
delivery before 37 weeks of gestations
Measured: at the time of delivery
Secondary outcomes (6)
Pre-term Birth <34, <32, and <28 weeks
delivery before 34, 32, and 28 weeks
Measured: at the time of delivery
Mean gestational age at delivery in weeks
Mean gestational age at delivery in weeks
Measured: at the time of delivery
Mean latency in days
Time from randomization to delivery
Measured: at the time of delivery
Maternal side effects related to the intervention
any maternal adverse events
Measured: at the time of delivery
Chorioamnionitis
inflammation of the chorion and amnion by histopathological assessment after delivery
Measured: at the time of delivery
Composite adverse perinatal outcome
Includes Nectrotizing Enterocolitis, Intraventricular Hemorrhage, Respiratory Distress syndrome, Bronchopolmunary dysplasia,Retinopathy of Prematurity, Blood-culture proven sepsis, Neonatal death.
Measured: Between birth and 28 days of ag
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Jun 2018
- Primary completion4 Sep 2019
- Study completion1 Nov 2019
Why it stopped: competing trial on same population.
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 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
- NCT03543475
- Sponsor's protocol ID
- 103/18
- Status last verified
- Dec 2019
- First submitted
- 30 Apr 2018
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided yet
Publications
Mastantuoni E, Saccone G, Gragnano E, Di Spiezio Sardo A, Zullo F, Locci M; Italian Preterm Birth Prevention Working Group. Cervical pessary in singleton gestations with arrested preterm labor: a randomized clinical trial. Am J Obstet Gynecol MFM. 2021 Mar;3(2):100307. doi: 10.1016/j.ajogmf.2021.100307. Epub 2021 Jan 7.
PubMed 33422659
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03543475
- Acronym / sponsor ID
- 103/18
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: competing trial on same population.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 1 Jun 2018 (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 a 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.
Different strategies have been studied for prevention of spontaneous PTB (SPTB) in randomized controlled trials (RCTs), including progesterone, cerclage, cervical pessary, as well as lifestyle modification, such as smoking cessation, diet, aerobic exercise, and nutritional supplements. Most successful effort to reduce the incidence of SPTB have focused on asympatomatic women with risk factors, such as prior SPTB or short cervix. However, most SPTB occur in symptomatic women, i.e. women with preterm labor (PTL). Women with arrested PTL are at increased risk of SPTB.
The cervical pessary is a silicone device that has been used to prevent SPTB. The leading hypotheses for its mechanisms are two: that the pessary helps to keep the cervix closed, and that the pessary changes the inclination of the cervical canal so that the pregnancy weight is not directly above the internal os.
The aim of the study is to assess the efficacy of pessary in reducing preterm birth in women with arrested preterm labor
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pessary | Experimental | Device: arabin pessarySilicon device applied on the cervix |
| No Pessary | Active comparator | Device: no pessarystandard care, no pessary |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton gestations
- Diagnosis of arrested PTL
- 18-50 years of age
- TVU CL ≤25mm at the time of randomization
Key exclusion criteria (11 listed)
- Multiple gestations
- Rupture of membranes at the time of randomization
- Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
- Fetal death at the time of randomization
- Cerclage in situ at the time of randomization
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 |
|---|---|---|
| arabin pessaryarabin pessary: silicon device | Device | Pessary |
| no pessarycontrol group | Device | No Pessary |
Primary outcome
Pre-term Birth
Time frame: at the time of delivery
delivery before 37 weeks of gestations
6 secondary outcomes
Pre-term Birth <34, <32, and <28 weeks
Time frame: at the time of delivery
Mean gestational age at delivery in weeks
Time frame: at the time of delivery
Mean latency in days
Time frame: at the time of delivery
Maternal side effects related to the intervention
Time frame: at the time of delivery
Chorioamnionitis
Time frame: at the time of delivery
Composite adverse perinatal outcome
Time frame: Between birth and 28 days of ag
Results and safety
The study was stopped early (reason given: competing trial on same population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Derived from this study: PubMed 33422659Mastantuoni E, Saccone G, Gragnano E, Di Spiezio Sardo A, Zullo F, Locci M; Italian Preterm Birth Prevention Working Group. Cervical pessary in singleton gestations with arrested preterm labor: a randomized clinical trial. Am J Obstet Gynecol MFM. 2021 Mar;3(2):100307. doi: 10.1016/j.ajogmf.2021.100307. Epub 2021 Jan 7.
- Individual participant dataSharing planned: Undecided. not decided yet
Related trials for Preterm Birth
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NEC - Necrotizing Enterocolitis
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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 study testing arabin pessary and no 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 4 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: stopped early, as of the sponsor's last update on 19 Dec 2019. 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?
The study was stopped early (reason given: competing trial on same population.). Results are not available in the source record.
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?
Pre-term Birth (time frame: at the time of delivery). 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 NCT03543475, 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 19 Dec 2019.