Preterm BirthPoPPSNCT02056652
Prevention of Preterm Birth With a Pessary in Singleton Gestations
A study testing Bioteque cup pessary in people with Preterm Birth and Short Cervix, run by University of Pennsylvania at 4 sites in United States.
Trial summary
Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm 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
- 122 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2014to Nov 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
- Singleton pregnancy (limits the participants to female gender)
- Short cervical length (less than or equal to 25 mm) on second trimester 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
4 sites in 1 country.
United States4 sites
Geisinger Medical Center
Danville, Pennsylvania, 17822
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 associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. The rate of PTB in the United States increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of PTB and is currently recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous PTB and through the development of an effective prevention for this complication. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing PTB. 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
- Preterm Birth, Short Cervix
- Being tested
- Bioteque cup pessary
- Keywords
- Preterm birth, Preterm 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 23 6/7 weeks gestation, and will be removed during the 37th 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 Subjects Experiencing Preterm Birth
Birth before 37 weeks gestation was captured.
Measured: Before 37 weeks gestation (20 0/7 - 36 6/7 weeks)
Secondary outcomes (5)
Average Birth Weight of Babies Born on Trial
The birth weights of babies born in the pessary group was compared to those born in the no pessary group
Measured: Time of delivery
Number of Participants That Experienced Spontaneous Preterm Births on Trial
The number of spontaneous births that occurred in participants on trial before 37 weeks was captured.
Measured: Before 37 weeks gestation
Number of Participants Experiencing Spontaneous Rupture of Membranes
Rupture of membranes before 34 weeks gestation was captured in each group.
Measured: Less than 34 weeks gestation
Number of Subjects Experiencing Neonatal Death
Number of participants who experienced neonatal deaths from birth to day 28 was captured for each group.
Measured: Between birth and 28 days of age
Number of Subjects Experiencing Chorioamnionitis
The AE of Chorioamnionitis was captured for 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 completionSep 2016
- Study completionNov 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.
- 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 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
- 122 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, MD, Principal investigator, Thomas Jefferson UniversityJack Ludmir, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056652
- Sponsor's protocol ID
- 817797
- Acronym
- PoPPS
- 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
Publications
Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2022 Dec 1;12(12):CD014508. doi: 10.1002/14651858.CD014508.
PubMed 36453699
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 Singleton Gestations
- ClinicalTrials.gov ID
- NCT02056652
- Acronym / sponsor ID
- PoPPS / 817797
- Conditions
- Preterm Birth, Short Cervix
- Keywords
- Preterm birth, Preterm delivery, short cervix, pessary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 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 associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. The rate of PTB in the United States increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of PTB and is currently recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous PTB and through the development of an effective prevention for this complication. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing PTB. 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 23 6/7 weeks gestation, and will be removed during the 37th 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
- Singleton pregnancy (limits the participants to female gender)
- Short cervical length (less than or equal to 25 mm) on second trimester 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 |
|---|---|---|
| Bioteque cup pessary | Device | Pessary |
Primary outcome
Number of Subjects Experiencing Preterm Birth
Time frame: Before 37 weeks gestation (20 0/7 - 36 6/7 weeks)
Birth before 37 weeks gestation was captured.
5 secondary outcomes
Average Birth Weight of Babies Born on Trial
Time frame: Time of delivery
Number of Participants That Experienced Spontaneous Preterm Births on Trial
Time frame: Before 37 weeks gestation
Number of Participants Experiencing Spontaneous Rupture of Membranes
Time frame: Less than 34 weeks gestation
Number of Subjects Experiencing 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.
- Derived from this study: PubMed 36453699Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2022 Dec 1;12(12):CD014508. doi: 10.1002/14651858.CD014508.
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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, MD principal investigator
Thomas Jefferson University
Jack Ludmir, MD principal investigator
University of Pennsylvania
4 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 Preterm Birth and Short Cervix, run by University of Pennsylvania at 4 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 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 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 4 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 Subjects Experiencing Preterm Birth (time frame: Before 37 weeks gestation (20 0/7 - 36 6/7 weeks)). 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 NCT02056652, 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 29 May 2018.