Preterm BirthPhase 4PECEP-TWINSNCT01242410

Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins

A Phase 4 study testing Silicon ring (Arabin Cervical Pessary) in people with Preterm Birth, run by Maternal-Infantil Vall d´Hebron Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with twins and a 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 Cervical Pessary)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 1 siteSpain
Study dates: Jan 2011to 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

Twins
Minimal age of 18 years

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Vall d'Herbron
Barcelona, Barcelona, 08036

Other trials in Spain

About this study

Official title: Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with twins and a short cervical length at 18-22 weeks scan.

Read the detailed description

This trial includes pregnant women with twins undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Conditions: Preterm Birth
Being tested: Silicon ring (Arabin Cervical Pessary)
Keywords: Short cervix, Preterm birth, Cervical pessary, Twins
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 Cervical Pessary)Device
Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003

Study groups in NCT01242410
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: Silicon ring (Arabin Cervical 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.

Jan 2011Jul 2014

First posted17 Nov 2010 (estimated)
Study startJan 2011
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 (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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01242410
Sponsor's protocol ID: Pessary in twins TRIAL
Acronym: PECEP-TWINS
Status last verified: Jul 2014
First submitted: 28 Sep 2010
Last updated: 12 May 2015
Results posted: No
Data monitoring committee: Yes

Publications

Goya M, de la Calle M, Pratcorona L, Merced C, Rodo C, Munoz B, Juan M, Serrano A, Llurba E, Higueras T, Carreras E, Cabero L; PECEP-Twins Trial Group. Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins). Am J Obstet Gynecol. 2016 Feb;214(2):145-152. doi: 10.1016/j.ajog.2015.11.012. Epub 2015 Nov 25.
PubMed 26627728

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Preterm Birth trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2015. 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 in Twins
ClinicalTrials.gov ID: NCT01242410
Acronym / sponsor ID: PECEP-TWINS / Pessary in twins TRIAL
Conditions: Preterm Birth
Keywords: Short cervix, Preterm birth, Cervical pessary, Twins
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Maternal-Infantil Vall d´Hebron HospitalUniversity, hospital or other
Study start: Jan 2011
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 twins and a short cervical length at 18-22 weeks scan.

Detailed description

This trial includes pregnant women with twins 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
Expectant Management	No intervention	–
Placement of cervical pessary since 23 weeks until 37 weeks	Experimental	Device: Silicon ring (Arabin Cervical Pessary)

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Twins
Minimal age of 18 years

Key exclusion criteria (5 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
Silicon ring (Arabin Cervical Pessary)Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003	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 12 May 2015.
Derived from this study: PubMed 26627728Goya M, de la Calle M, Pratcorona L, Merced C, Rodo C, Munoz B, Juan M, Serrano A, Llurba E, Higueras T, Carreras E, Cabero L; PECEP-Twins Trial Group. Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins). Am J Obstet Gynecol. 2016 Feb;214(2):145-152. doi: 10.1016/j.ajog.2015.11.012. Epub 2015 Nov 25.

Related trials for Preterm Birth

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia

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 M 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 Silicon ring (Arabin Cervical 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 5 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 12 May 2015. 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 NCT01242410, 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 12 May 2015.