Preterm BirthPhase 3PWKNCT02849301
Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix
A Phase 3 study testing Arabin cervical pessary in people with Preterm Birth, run by Federico II University at 1 site in Italy.
Trial summary
Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S. healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths are directly attributable to PTB. 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 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
- Jul 2016to Mar 2018
- 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 ages
- Singleton pregnancy
- 24(0) - 34(6) weeks of gestation
- Arrested preterm labor after primary tocolysis
- Transvaginal ultrasound cervical length less than 25mm at admission
- Agreement to regular follow-up and provision of written informed consent
Who cannot join
- pessary and no cerclage in situ
- vaginal bleeding
- placeta previa/accreta
- multiple gestations
- <24(0) or >24(6) weeks of gestation
- Cervical dilatation greater than 3 cm
Show all 13Show fewer
- Chorioamnionitis
- Major fetal abnormalities
- Abruptio placentae
- PPROM
- Polyhydramnios or oligohydramnios
- IUGR/FGR with or without Doppler abnormalities
- Preeclampsia or pregnancy-related hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S. healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths are directly attributable to PTB.
Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.
The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin pessary compared to standard care in singleton gestations with arrested PTL and with short transvaginal ultrasound (TVU) cervical length (CL) <25mm
- Conditions
- Preterm Birth
- Being tested
- Arabin 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.
Arabin cervical pessaryDevice
| Study group | Role | What they receive |
|---|---|---|
| Cervical pessary | Experimental | Arabin cervical pessary Receives: Device: Arabin cervical pessary |
| Standard care | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous preterm birth (SPTB)
Measured: Less than 34 weeks gestation
Secondary outcomes (9)
Spontaneous preterm birth (SPTB)
Measured: Less than 37,35,32,28 and 24 weeks gestation
Gestational age at delivery
mean gestational age at delivery
Measured: Delivery (at birth)
Latency
mean latency in days (from randomization to delivery)
Measured: Delivery (at birth)
Birth weight
mean birth weight in grams
Measured: Delivery (at birth)
Admission to neonatal intensive care unit
Measured: Delivery (at birth)
respiratory distress syndrome
Measured: Delivery (at birth)
low birth weight
birth weight <2500 grams
Measured: Delivery (at birth)
intraventricular hemorrhage
grade 3 or 4
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionMar 2018
Why it stopped: different protocol started, new registration
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- NCT02849301
- Sponsor's protocol ID
- 2378
- Acronym
- PWK
- Status last verified
- Nov 2018
- First submitted
- 27 Jul 2016
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
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
- Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix
- ClinicalTrials.gov ID
- NCT02849301
- Acronym / sponsor ID
- PWK / 2378
- Conditions
- Preterm Birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: different protocol started, new registration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 29 Jul 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 (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S. healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths are directly attributable to PTB.
Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.
The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin pessary compared to standard care in singleton gestations with arrested PTL and with short transvaginal ultrasound (TVU) cervical length (CL) <25mm
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: Arabin cervical pessaryArabin cervical pessary |
| Standard care | No intervention | –No treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-50 ages
- Singleton pregnancy
- 24(0) - 34(6) weeks of gestation
- Arrested preterm labor after primary tocolysis
- Transvaginal ultrasound cervical length less than 25mm at admission
Key exclusion criteria (13 listed)
- pessary and no cerclage in situ
- vaginal bleeding
- placeta previa/accreta
- multiple gestations
- <24(0) or >24(6) weeks of gestation
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 cervical pessary | Device | Cervical pessary |
Primary outcome
Spontaneous preterm birth (SPTB)
Time frame: Less than 34 weeks gestation
9 secondary outcomes
Spontaneous preterm birth (SPTB)
Time frame: Less than 37,35,32,28 and 24 weeks gestation
Gestational age at delivery
Time frame: Delivery (at birth)
Latency
Time frame: Delivery (at birth)
Birth weight
Time frame: Delivery (at birth)
Admission to neonatal intensive care unit
Time frame: Delivery (at birth)
respiratory distress syndrome
Time frame: Delivery (at birth)
low birth weight
Time frame: Delivery (at birth)
intraventricular hemorrhage
Time frame: Between birth and 28 days of age
neonatal mortality
Time frame: Between birth and 28 days of age
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.
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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 Arabin 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 6 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: 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 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 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?
Spontaneous preterm birth (SPTB) (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.