Premature BirthPoPPTNCT02056639
Prevention of Preterm Birth With a Pessary in Twin Gestations
A study testing Bioteque cup pessary in people with Premature Birth and Short Cervix, run by University of Pennsylvania at 3 sites in United States.
Trial summary
Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall perinatal mortality. Twins are at increased risk for PTB. The number of twins births has risen substantially due to the increased use of assisted reproductive technology. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Premature Birth, Short Cervix
- What is being tested?
- Bioteque cup pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18-27 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
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- 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
3 sites in 1 country.
United States3 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall perinatal mortality. Twins are at increased risk for PTB. The number of twins births has risen substantially due to the increased use of assisted reproductive technology. The rate of twin births in the United States rose from 18.9 to 32.2 per 100 live births between 1980 and 2004. The increased rate of PTB in twins is associated with increased morbidity and mortality rates. Almost one in four very low birth-weight infants (below 1500 g) born in the United States are twins, as are one in six infants who die in the first month of life. Cervical shortening is a risk factor for PTB. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. There is currently no effective treatment to decrease the incidence of PTB in women with twin gestations, but there is some evidence that the use of a cervical pessary in women with a short cervix has promise. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.
- Conditions
- Premature Birth, Short Cervix
- Being tested
- Bioteque cup pessary
- Keywords
- Premature birth, Premature delivery, Short cervix, 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.
Bioteque cup pessaryDevice
| Study group | Role | What they receive |
|---|---|---|
| Pessary | Experimental | Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated) Receives: Device: Bioteque cup pessary |
| No pessary | No intervention | 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.
Number of Participants With Preterm Delivery
Measured: Less than 34 weeks gestation
Secondary outcomes (4)
Average Birth Weight of Babies in Each Group
The birth weight of babies is the pessary group and no pessary group were recorded and analyzed for comparison.
Measured: Time of delivery
Spontaneous Preterm Birth Rates
Measured: Less than 37 weeks gestation
Number of Participants That Experienced Neonatal Death
Number of participants that experienced neonatal deaths that occurred in each group following birth was recorded and analyzed.
Measured: Between birth and 28 days of age
Number of Subjects Experiencing Chorioamnionitis
Chorioamnionitis was recorded and analyzed for participants in each group.
Measured: Time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorraine Dugoff, MD, Principal investigator, University of PennsylvaniaVincenzo Berghella, Principal investigator, Thomas Jefferson UniversityJack Ludmir, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056639
- Sponsor's protocol ID
- 819122
- Acronym
- PoPPT
- Status last verified
- Apr 2018
- First submitted
- 4 Feb 2014
- Last updated
- 29 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Preterm Birth With a Pessary in Twin Gestations
- ClinicalTrials.gov ID
- NCT02056639
- Acronym / sponsor ID
- PoPPT / 819122
- Conditions
- Premature Birth, Short Cervix
- Keywords
- Premature birth, Premature delivery, Short cervix, Pessary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Posted 29 May 2018
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 health problem and contributes to more than 50% of the overall perinatal mortality. Twins are at increased risk for PTB. The number of twins births has risen substantially due to the increased use of assisted reproductive technology. The rate of twin births in the United States rose from 18.9 to 32.2 per 100 live births between 1980 and 2004. The increased rate of PTB in twins is associated with increased morbidity and mortality rates. Almost one in four very low birth-weight infants (below 1500 g) born in the United States are twins, as are one in six infants who die in the first month of life. Cervical shortening is a risk factor for PTB. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. There is currently no effective treatment to decrease the incidence of PTB in women with twin gestations, but there is some evidence that the use of a cervical pessary in women with a short cervix has promise. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pessary | Experimental | Device: Bioteque cup pessaryUse of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated) |
| No pessary | No intervention | –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 18-27 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 |
|---|---|---|
| Bioteque cup pessary | Device | Pessary |
Primary outcome
Number of Participants With Preterm Delivery
Time frame: Less than 34 weeks gestation
4 secondary outcomes
Average Birth Weight of Babies in Each Group
Time frame: Time of delivery
Spontaneous Preterm Birth Rates
Time frame: Less than 37 weeks gestation
Number of Participants That Experienced Neonatal Death
Time frame: Between birth and 28 days of age
Number of Subjects Experiencing Chorioamnionitis
Time frame: Time of delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lorraine Dugoff, MD principal investigator
University of Pennsylvania
Vincenzo Berghella principal investigator
Thomas Jefferson University
Jack Ludmir principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioteque cup pessary in people with Premature Birth and Short Cervix, run by University of Pennsylvania at 3 sites in United States.
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: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 29 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With 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 29 May 2018.