Preterm BirthPhase 4PECEP-RETARDNCT01242384
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)
A Phase 4 study testing Device: Silicon ring (Arabin Pessary) in people with Preterm Birth, run by Maternal-Infantil Vall d´Hebron Hospital at 1 site in Spain.
Trial summary
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Device: Silicon ring (Arabin Pessary)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2008to Jul 2014
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Minimal age of 18 years
- Episode of threatened preterm labour
Who cannot join
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- Spontaneous rupture of membranes at the time of randomization
- Cervical cerclage in situ
- Active vaginal bleeding
- Placenta previa
- Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.
- Conditions
- Preterm Birth
- Being tested
- Device: Silicon ring (Arabin 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.
Device: Silicon ring (Arabin Pessary)Device
Placement of a silicon pessary in the vagina, around the cervix.
| Study group | Role | What they receive |
|---|---|---|
| Expectant Management | No intervention | Not described |
| Placement of cervical pessary since 23 weeks until 37 weeks | Experimental | Not described Receives: Device: Device: Silicon ring (Arabin Pessary) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous delivery before 34 completed weeks
Measured: Each 6 months
Secondary outcomes (7)
Birth weight
Measured: Each 6 months
Fetal-Neonatal Death
Measured: Each 6 months
Neonatal morbidity
Measured: Each 6 months
Maternal adverse effects
Measured: Each 6 months
Preterm birth before 37 weeks or 28 weeks
Measured: Each 6 months
Rupture of membranes before 34 weeks
Measured: Each 6 months
Hospitalisation for threatened preterm labour
Measured: Each 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startJun 2008
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal-Infantil Vall d´Hebron Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
- Investigators
- Elena Carreras, Study director, Hospital Vall d'HebronMaria Goya, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242384
- Sponsor's protocol ID
- PECEP-RETARD TRIAL
- Acronym
- PECEP-RETARD
- Status last verified
- Sep 2016
- First submitted
- 28 Sep 2010
- Last updated
- 20 Sep 2016
- Results posted
- No
- 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 36453699Merced C, Goya M, Pratcorona L, Rodo C, Llurba E, Higueras T, Cabero L, Carreras E; PECEP-RETARD Trial Group. Cervical pessary for preventing preterm birth in twin pregnancies with maternal short cervix after an episode of threatened preterm labor: randomised controlled trial. Am J Obstet Gynecol. 2019 Jul;221(1):55.e1-55.e14. doi: 10.1016/j.ajog.2019.02.035. Epub 2019 Feb 28.
PubMed 30826339
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor
- ClinicalTrials.gov ID
- NCT01242384
- Acronym / sponsor ID
- PECEP-RETARD / PECEP-RETARD TRIAL
- Conditions
- Preterm Birth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Maternal-Infantil Vall d´Hebron HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Nov 2010 (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.
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expectant Management | No intervention | – |
| Placement of cervical pessary since 23 weeks until 37 weeks | Experimental | Device: Device: Silicon ring (Arabin Pessary) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Minimal age of 18 years
- Episode of threatened preterm labour
Key exclusion criteria (6 listed)
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- Spontaneous rupture of membranes at the time of randomization
- Cervical cerclage in situ
- Active vaginal bleeding
- Placenta previa
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 |
|---|---|---|
| Device: Silicon ring (Arabin Pessary)Placement of a silicon pessary in the vagina, around the cervix. | Device | Placement of cervical pessary since 23 weeks until 37 weeks |
Primary outcome
Spontaneous delivery before 34 completed weeks
Time frame: Each 6 months
7 secondary outcomes
Birth weight
Time frame: Each 6 months
Fetal-Neonatal Death
Time frame: Each 6 months
Neonatal morbidity
Time frame: Each 6 months
Maternal adverse effects
Time frame: Each 6 months
Preterm birth before 37 weeks or 28 weeks
Time frame: Each 6 months
Rupture of membranes before 34 weeks
Time frame: Each 6 months
Hospitalisation for threatened preterm labour
Time frame: Each 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- 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.
- Derived from this study: PubMed 30826339Merced C, Goya M, Pratcorona L, Rodo C, Llurba E, Higueras T, Cabero L, Carreras E; PECEP-RETARD Trial Group. Cervical pessary for preventing preterm birth in twin pregnancies with maternal short cervix after an episode of threatened preterm labor: randomised controlled trial. Am J Obstet Gynecol. 2019 Jul;221(1):55.e1-55.e14. doi: 10.1016/j.ajog.2019.02.035. Epub 2019 Feb 28.
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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.
Elena Carreras study director
Hospital Vall d'Hebron
Maria Goya principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Device: Silicon ring (Arabin Pessary) in people with Preterm Birth, run by Maternal-Infantil Vall d´Hebron Hospital at 1 site in Spain.
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 2 inclusion and 6 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 20 Sep 2016. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 delivery before 34 completed weeks (time frame: Each 6 months). 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 NCT01242384, which also lists 2 linked publications.
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 20 Sep 2016.