Premature BirthPECEPLASERNCT01334489
The Trial of Pessary After Laser for TTTS
A study testing Arabin Cervical Pessary in people with Premature Birth, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in 3 countries.
Trial summary
Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated by fetoscopic laser coagulation (FLC) decreases the spontaneous preterm birth rate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premature Birth
- What is being tested?
- Arabin Cervical Pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Dec 2012to 25 Jun 2020
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Monochorionic twin pregnancies with severe TTTS requiring intrauterine surgery
- Less than 26 weeks
- Minimal age of 18 years
- Informed consent signature
Who cannot join
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- Cerclage prior to randomisation
- Uterine malformation
- Placenta previa
- Active vaginal bleeding at the moment of randomization
- Spontaneous rupture of membranes at the time of randomization
Show all 10Show fewer
- Death of both twins after the surgery
- Monochorionic-monoamniotic twin pregnancy
- Silicone allergy
- Current participation in other RCT
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Frauenklinik - Zentrum für Ultraschalldiagnostik und Pränatalmedizin Bürgerhospital und Clementine Kinderhospital gemeinnützige GmbH
Frankfurt, 60318
University Medical Center Eppendorf
Hamburg, 20246
About this study
Official title: Arabin Cervical Pessary for Prevention of Preterm Birth in Cases of Twin-to-twin Transfusion Syndrome Treated by Fetoscopic Laser Coagulation: The PECEP Laser Trial
Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated by fetoscopic laser coagulation (FLC) decreases the spontaneous preterm birth rate.
Read the detailed description
Monochorionic (MC) twin pregnancies present with a high rate of fetal complications, most of them associated with the placental vascular anastomoses. Fetoscopic laser coagulation (FLC) is a surgical technique that allows minimally invasive access into the uterus and has emerged as a useful tool in the management of the most common and severe of these complications, twin to twin transfusion syndrome (TTTS). Even though, preterm birth remains a common cause of adverse outcome because TTTS is associated with a 29% risk of delivering before 28 weeks.
A short cervical length (CL), defined as a CL ≤ 25 mm, detected by transvaginal ultrasound is an independent risk factor for preterm birth in twin pregnancies but no effective treatment has been described to prevent it.
Although is usually accepted that in twin pregnancies cerclage may increase the risk of preterm birth, Salomon and co-workers, found that in cases of TTTS with a CL below the 5th percentile (15 mm) at the time of surgery, performing an emergency cerclage prolonged the pregnancy and allow for better outcome, But still preterm birth after FLC remains a big challenge, so new methods to prevent it must be investigated.
Previous studies in singletons and twins have shown that the use of cervical pessary significantly reduces the frequency of birth before 32 weeks and prolongs pregnancy. The advantage of using cervical pessary is that it is less invasive than cerclage and can be removed easily. That's the reason why pessaries could be considered an alternative, non invasive option to prevent preterm birth in cases of twin to twin transfusion syndrome (TTTS) treated by laser surgery.
- Conditions
- Premature Birth
- Being tested
- Arabin Cervical Pessary
- Keywords
- Monochorionic pregnancy, Twin to twin transfusion syndrome, Cervical pessary, Cervical length
- Medical subject headings
- Premature Birth, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabin Cervical PessaryDevice
The Arabin cervical pessary, which is CE-certified for preventing SPB (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC).
It is a vaginal device which is used to treat pregnant women for preventing spontaneous preterm birth. This device can be easily placed around the uterine cervix without pain.
| Study group | Role | What they receive |
|---|---|---|
| Usual management | No intervention | Usual management of monochorionic pregnancy without the pessary placement |
| Arabin Cervical Pessary | Other | The pessary will be inserted 24 hours after fetal surgery in the exploration room. This procedure does not need anaesthesia and it does not need to be done in a surgery room. During the following explorations the correct placement of the pessary is assessed, and if it does not, it can be easily adjusted.
The pessary will be removed at 37 weeks of gestation, or before if any unexpected event occurs. Receives: Device: Arabin Cervical Pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery before 32 weeks
Rate of delivery before 32 weeks
Measured: Within the first 15 days after delivery
Secondary outcomes (12)
Birth weight
Median weight (g) of the newborns at birth.
Measured: Within the first 15 days after delivery
Fetal or neonatal death
Rate of intrauterine demise or neonatal death during the first 24 hours.
Measured: Within the first 15 days after the death
Neonatal morbidity
Rate of major adverse neonatal outcomes before discharge from the hospital.
Measured: 30 days after the discharge from the hospital
Significant maternal adverse events
Rate of heavy bleeding (bleeding that requires a medical intervention), cervical tear (cervical rupture due to the pessary placement), and/or uterine rupture (rupture of the uterus due to contractions or surgery).
Measured: Within 15 days after discharge from the hospital
Physical or psychological intolerance to pessary
Discomfort or pain due to the pessary that makes daily life uncomfortable (number of cases).
Measured: Within 15 days after discharge from hospital
Preterm birth before 37 weeks
Rate of delivery before 36+6 weeks
Measured: Within 15 days after delivery
Rupture of membranes before 32 weeks
Rupture of amniotic membranes before 31+6 weeks
Measured: Within 15 days after delivery
Hospitalisation for threatened preterm labour before 32 weeks
Requirement of hospitalisation due to preterm contractions that need medical treatment to try to stop them before 31+6 weeks (rate).
Measured: Within 15 days after delivery
Time to birth
Measured: Within 15 days after delivery
Preterm birth before 34 weeks
rate of delivery before 33+6 weeks
Measured: Within 15 days after delivery
Preterm birth before 30 weeks
rate of delivery before 29+6 weeks
Measured: Within 15 days after delivery
Preterm birth before 28 weeks
rate of delivery before 27+6 weeks
Measured: Within 15 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startDec 2012
- Primary completionJan 2020
- Study completion25 Jun 2020
Why it stopped: Interim analysis unfavorable to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Maternal-Infantil Vall d´Hebron Hospital, Universitaire Ziekenhuizen KU Leuven, Universitätsklinikum Hamburg-Eppendorf, Bürgerhospital Frankfurt
- Responsible party
- Sponsor
- Investigators
- Elena Carreras, PhD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334489
- Sponsor's protocol ID
- PECEP_LASER Trial
- Acronym
- PECEPLASER
- Status last verified
- Aug 2020
- First submitted
- 12 Apr 2011
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carreras E, Arevalo S, Bello-Munoz JC, Goya M, Rodo C, Sanchez-Duran MA, Peiro JL, Cabero L. Arabin cervical pessary to prevent preterm birth in severe twin-to-twin transfusion syndrome treated by laser surgery. Prenat Diagn. 2012 Dec;32(12):1181-5. doi: 10.1002/pd.3982. Epub 2012 Oct 11.
PubMed 23055333Goya 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 22475493Goya M, Pratcorona L, Higueras T, Perez-Hoyos S, Carreras E, Cabero L. Sonographic cervical length measurement in pregnant women with a cervical pessary. Ultrasound Obstet Gynecol. 2011 Aug;38(2):205-9. doi: 10.1002/uog.8960. Epub 2011 Jul 18.
PubMed 21305638Liem S, Schuit E, Hegeman M, Bais J, de Boer K, Bloemenkamp K, Brons J, Duvekot H, Bijvank BN, Franssen M, Gaugler I, de Graaf I, Oudijk M, Papatsonis D, Pernet P, Porath M, Scheepers L, Sikkema M, Sporken J, Visser H, van Wijngaarden W, Woiski M, van Pampus M, Mol BW, Bekedam D. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial. Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5.
PubMed 23924878Rodo C, Maiz N, Arevalo S, Lewi L, Couck I, Hollwitz B, Kyvernitakis I, Carreras E, Hecher K. The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2024 Aug;231(2):252.e1-252.e11. doi: 10.1016/j.ajog.2023.11.1245. Epub 2023 Nov 29.
PubMed 38036166Rodo C, Arevalo S, Lewi L, Couck I, Hollwitz B, Hecher K, Carreras E. Arabin cervical pessary for prevention of preterm birth in cases of twin-to-twin transfusion syndrome treated by fetoscopic LASER coagulation: the PECEP LASER randomised controlled trial. BMC Pregnancy Childbirth. 2017 Aug 1;17(1):256. doi: 10.1186/s12884-017-1435-0.
PubMed 28764674
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arabin Cervical Pessary for Prevention of Preterm Birth in Cases of Twin-to-twin Transfusion Syndrome Treated by Fetoscopic Laser Coagulation: The PECEP Laser Trial
- ClinicalTrials.gov ID
- NCT01334489
- Acronym / sponsor ID
- PECEPLASER / PECEP_LASER Trial
- Conditions
- Premature Birth
- Keywords
- Monochorionic pregnancy, Twin to twin transfusion syndrome, Cervical pessary, Cervical length
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis unfavorable to continue the study
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Maternal-Infantil Vall d´Hebron Hospital, Universitaire Ziekenhuizen KU Leuven, Universitätsklinikum Hamburg-Eppendorf, Bürgerhospital Frankfurt
- Study start
- Dec 2012 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 13 Apr 2011 (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.
Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated by fetoscopic laser coagulation (FLC) decreases the spontaneous preterm birth rate.
Detailed description
Monochorionic (MC) twin pregnancies present with a high rate of fetal complications, most of them associated with the placental vascular anastomoses. Fetoscopic laser coagulation (FLC) is a surgical technique that allows minimally invasive access into the uterus and has emerged as a useful tool in the management of the most common and severe of these complications, twin to twin transfusion syndrome (TTTS). Even though, preterm birth remains a common cause of adverse outcome because TTTS is associated with a 29% risk of delivering before 28 weeks.
A short cervical length (CL), defined as a CL ≤ 25 mm, detected by transvaginal ultrasound is an independent risk factor for preterm birth in twin pregnancies but no effective treatment has been described to prevent it.
Although is usually accepted that in twin pregnancies cerclage may increase the risk of preterm birth, Salomon and co-workers, found that in cases of TTTS with a CL below the 5th percentile (15 mm) at the time of surgery, performing an emergency cerclage prolonged the pregnancy and allow for better outcome, But still preterm birth after FLC remains a big challenge, so new methods to prevent it must be investigated.
Previous studies in singletons and twins have shown that the use of cervical pessary significantly reduces the frequency of birth before 32 weeks and prolongs pregnancy. The advantage of using cervical pessary is that it is less invasive than cerclage and can be removed easily. That's the reason why pessaries could be considered an alternative, non invasive option to prevent preterm birth in cases of twin to twin transfusion syndrome (TTTS) treated by laser surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual management | No intervention | –Usual management of monochorionic pregnancy without the pessary placement |
| Arabin Cervical Pessary | Other | Device: Arabin Cervical PessaryThe pessary will be inserted 24 hours after fetal surgery in the exploration room. This procedure does not need anaesthesia and it does not need to be done in a surgery room. During the following explorations the correct placement of the pessary is assessed, and if it does not, it can be easily adjusted. The pessary will be removed at 37 weeks of gestation, or before if any unexpected event occurs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Monochorionic twin pregnancies with severe TTTS requiring intrauterine surgery
- Less than 26 weeks
- Minimal age of 18 years
- Informed consent signature
Key exclusion criteria (10 listed)
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- Cerclage prior to randomisation
- Uterine malformation
- Placenta previa
- Active vaginal bleeding at the moment of randomization
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 |
|---|---|---|
| Arabin Cervical PessaryThe Arabin cervical pessary, which is CE-certified for preventing SPB (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC). It is a vaginal device which is used to treat pregnant women for preventing spontaneous preterm birth. This device can be easily placed around the uterine cervix without pain. | Device | Arabin Cervical Pessary |
Primary outcome
Delivery before 32 weeks
Time frame: Within the first 15 days after delivery
Rate of delivery before 32 weeks
12 secondary outcomes
Birth weight
Time frame: Within the first 15 days after delivery
Fetal or neonatal death
Time frame: Within the first 15 days after the death
Neonatal morbidity
Time frame: 30 days after the discharge from the hospital
Significant maternal adverse events
Time frame: Within 15 days after discharge from the hospital
Physical or psychological intolerance to pessary
Time frame: Within 15 days after discharge from hospital
Preterm birth before 37 weeks
Time frame: Within 15 days after delivery
Rupture of membranes before 32 weeks
Time frame: Within 15 days after delivery
Hospitalisation for threatened preterm labour before 32 weeks
Time frame: Within 15 days after delivery
Time to birth
Time frame: Within 15 days after delivery
Preterm birth before 34 weeks
Time frame: Within 15 days after delivery
Preterm birth before 30 weeks
Time frame: Within 15 days after delivery
Preterm birth before 28 weeks
Time frame: Within 15 days after delivery
Results and safety
The study was stopped early (reason given: Interim analysis unfavorable to continue the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Background: PubMed 23055333Carreras E, Arevalo S, Bello-Munoz JC, Goya M, Rodo C, Sanchez-Duran MA, Peiro JL, Cabero L. Arabin cervical pessary to prevent preterm birth in severe twin-to-twin transfusion syndrome treated by laser surgery. Prenat Diagn. 2012 Dec;32(12):1181-5. doi: 10.1002/pd.3982. Epub 2012 Oct 11.
- Background: 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.
- Background: PubMed 21305638Goya M, Pratcorona L, Higueras T, Perez-Hoyos S, Carreras E, Cabero L. Sonographic cervical length measurement in pregnant women with a cervical pessary. Ultrasound Obstet Gynecol. 2011 Aug;38(2):205-9. doi: 10.1002/uog.8960. Epub 2011 Jul 18.
- Background: PubMed 23924878Liem S, Schuit E, Hegeman M, Bais J, de Boer K, Bloemenkamp K, Brons J, Duvekot H, Bijvank BN, Franssen M, Gaugler I, de Graaf I, Oudijk M, Papatsonis D, Pernet P, Porath M, Scheepers L, Sikkema M, Sporken J, Visser H, van Wijngaarden W, Woiski M, van Pampus M, Mol BW, Bekedam D. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial. Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5.
- Derived from this study: PubMed 38036166Rodo C, Maiz N, Arevalo S, Lewi L, Couck I, Hollwitz B, Kyvernitakis I, Carreras E, Hecher K. The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2024 Aug;231(2):252.e1-252.e11. doi: 10.1016/j.ajog.2023.11.1245. Epub 2023 Nov 29.
- Derived from this study: PubMed 28764674Rodo C, Arevalo S, Lewi L, Couck I, Hollwitz B, Hecher K, Carreras E. Arabin cervical pessary for prevention of preterm birth in cases of twin-to-twin transfusion syndrome treated by fetoscopic LASER coagulation: the PECEP LASER randomised controlled trial. BMC Pregnancy Childbirth. 2017 Aug 1;17(1):256. doi: 10.1186/s12884-017-1435-0.
- Arabin Cervical PessaryLink provided by the sponsor.
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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 principal investigator
Hospital Vall d'Hebron
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arabin Cervical Pessary in people with Premature Birth, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in 3 countries.
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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 27 Aug 2020. 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 Germany, Belgium, 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?
The study was stopped early (reason given: Interim analysis unfavorable to continue the study). Results are not available in the source record.
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?
Delivery before 32 weeks (time frame: Within the first 15 days after delivery). 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 NCT01334489, which also lists 6 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 27 Aug 2020.