Preterm BirthPECEPNCT00706264
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix
A study testing Silicon ring (Arabin Pessary) in people with Preterm Birth, run by Maternal-Infantil Vall d´Hebron Hospital at 6 sites in Spain.
Trial summary
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan. 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?
- Silicon ring (Arabin Pessary)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 6 sitesSpain
- Study dates
- Jun 2007to Jul 2014
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Minimal age of 18 years
Who cannot join
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- SROM at the time of randomization
- Cervical cerclage in situ
- Active vaginal bleeding
- Previous cone biopsy or cerclage
- Major uterine structural anomalies
- Placenta previa
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Vall d´Hebron
Barcelona, 08035
Institut Universitary Dexeus
Barcelona
Hospital Materno-Infantil de Canarias
Las Palmas de Gran Canaria, Gran Canaria, 35016
Hospital de Fuenlabrada
Madrid
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, 07198
Hospital de Reus
Reus, Tarragona
About this study
Official title: Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.
Read the detailed description
This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
- Conditions
- Preterm Birth
- Being tested
- Silicon ring (Arabin Pessary)
- Keywords
- Short cervix, preterm birth, 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.
Silicon ring (Arabin Pessary)Device
Also called Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
Placement of a silicon pessary in the vagina, around the cervix.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Expectant management |
| 2 | Experimental | Placement of arabin pessary since 23 weeks until 37 weeks Receives: 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
Number of spontaneous preterm births before 34 weeks occurred in each group.
Measured: Between 24 and 34 weeks
Secondary outcomes (23)
Birthweight Less Than 1500 g
Number of newborns whose birthweight is less than 1500 grams
Measured: Time of delivery
Birthweight Less Than 2500 g
Number of newborns whose birthweight is less than 2500 grams
Measured: Time of delivery
Intrauterine Fetal Demise
The number of fetal deaths in the pessary group was compared to those in the no pessary group
Measured: Pregnancy
Neonatal Death
The number of neonatal deaths in the pessary group was compared to those in the no pessary group
Measured: Between birth and 28 days of age
Intraventricular Haemorrhage
The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group
Measured: Between birth and 28 days of age
Respiratory Distress Syndrome
The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group
Measured: Between birth and 28 days of age
Retinopathy of Prematurity
The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group
Measured: Between birth and 28 days of age
Necrotising Enterocolitis
The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group
Measured: Between birth and 28 days of age
Treatment for Sepsis
The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group
Measured: Between birth and 28 days of age
Composite Adverse Outcomes
The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group
Measured: Between birth and 28 days of age
Spontaneous Delivery Before 28 Completed Weeks
Number of preterm births before 28 weeks occurred in each group.
Measured: Between 24 and 28 weeks
Any Delivery Before 34 Completed Weeks
Number of all preterm births before 34 weeks occurred in each group.
Measured: Between 24 and 34 weeks
Spontaneous Delivery Before 37 Completed Weeks
Number of preterm births before 37 weeks occurred in each group.
Measured: Between 24 and 37 weeks
Gestational Age at Delivery
Number of weeks of gestation completed by time of delivery
Measured: At time of birth
Use of Tocolysis
Number of participants required use of tocolytic medication
Measured: participants will be followed for the duration of pregnancy, up to nine months
Use of Antenatal Steroids
Number of participants that received betamethasone to reduce morbidity of expected preterm delivery
Measured: participants will be followed for the duration of pregnancy, up to nine months
Chorioamnionitis
Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Measured: participants will be followed for the duration of pregnancy, up to nine months
Vaginal Bleeding
Number of participants who experienced bleeding from lower genital tract during antepartum period
Measured: participants will be followed for the duration of pregnancy, up to nine months
Preterm Premature Rupture of Membranes
Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Measured: participants will be followed for the duration of pregnancy, up to nine months
Cesarean Delivery
Number of participants that underwent cesarean delivery
Measured: At time of delivery
Vaginal Discharge
Number of participants who experienced an increased vaginal discharge.
Measured: participants will be followed for the duration of pregnancy, up to nine months
Pessary Repositioning Without Removal
Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).
Measured: participants will be followed for the duration of pregnancy, up to nine months
Pessary Withdrawal
Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).
Measured: participants will be followed for the duration of pregnancy, up to nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionJul 2014
- Study completionJul 2014
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.
- 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
- Outcomes assessor
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal-Infantil Vall d´Hebron Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Canarias, Hospital Son Llatzer, Fundacion Dexeus
- Responsible party
- Principal investigator, Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
- Investigators
- ELENA CARRERAS, PhD, Study director, Maternal-Infantil Vall d´Hebron Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706264
- Sponsor's protocol ID
- PECEP-TRIAL
- Acronym
- PECEP
- Status last verified
- Mar 2021
- First submitted
- 24 Jun 2008
- Last updated
- 17 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3.
PubMed 22475493
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)
- ClinicalTrials.gov ID
- NCT00706264
- Acronym / sponsor ID
- PECEP / PECEP-TRIAL
- Conditions
- Preterm Birth
- Keywords
- Short cervix, preterm birth, arabin pessary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Maternal-Infantil Vall d´Hebron HospitalUniversity, hospital or other
- Collaborators
- Hospital Universitario de Canarias, Hospital Son Llatzer, Fundacion Dexeus
- Study start
- Jun 2007
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 17 Mar 2021
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 at 18-22 weeks scan.
Detailed description
This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Expectant management |
| 2 | Experimental | Device: Silicon ring (Arabin Pessary)Placement of arabin pessary since 23 weeks until 37 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Minimal age of 18 years
Key exclusion criteria (7 listed)
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- SROM at the time of randomization
- Cervical cerclage in situ
- Active vaginal bleeding
- Previous cone biopsy or cerclage
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 |
|---|---|---|
| Silicon ring (Arabin Pessary)Also: Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003Placement of a silicon pessary in the vagina, around the cervix. | Device | 2 |
Primary outcome
Spontaneous Delivery Before 34 Completed Weeks
Time frame: Between 24 and 34 weeks
Number of spontaneous preterm births before 34 weeks occurred in each group.
23 secondary outcomes
Birthweight Less Than 1500 g
Time frame: Time of delivery
Birthweight Less Than 2500 g
Time frame: Time of delivery
Intrauterine Fetal Demise
Time frame: Pregnancy
Neonatal Death
Time frame: Between birth and 28 days of age
Intraventricular Haemorrhage
Time frame: Between birth and 28 days of age
Respiratory Distress Syndrome
Time frame: Between birth and 28 days of age
Retinopathy of Prematurity
Time frame: Between birth and 28 days of age
Necrotising Enterocolitis
Time frame: Between birth and 28 days of age
Treatment for Sepsis
Time frame: Between birth and 28 days of age
Composite Adverse Outcomes
Time frame: Between birth and 28 days of age
Spontaneous Delivery Before 28 Completed Weeks
Time frame: Between 24 and 28 weeks
Any Delivery Before 34 Completed Weeks
Time frame: Between 24 and 34 weeks
Spontaneous Delivery Before 37 Completed Weeks
Time frame: Between 24 and 37 weeks
Gestational Age at Delivery
Time frame: At time of birth
Use of Tocolysis
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Use of Antenatal Steroids
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Chorioamnionitis
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Vaginal Bleeding
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Preterm Premature Rupture of Membranes
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Cesarean Delivery
Time frame: At time of delivery
Vaginal Discharge
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Pessary Repositioning Without Removal
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Pessary Withdrawal
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22475493Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3.
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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, PhD study director
Maternal-Infantil Vall d´Hebron Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicon ring (Arabin Pessary) in people with Preterm Birth, run by Maternal-Infantil Vall d´Hebron Hospital at 6 sites 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 7 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2021). 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?
Spontaneous Delivery Before 34 Completed Weeks (time frame: Between 24 and 34 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 NCT00706264, 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 17 Mar 2021.