Skip to content

The Trial of Pessary After Laser for TTTS

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01334489
Acronym
PECEPLASER
Enrollment
352
Registered
2011-04-13
Start date
2012-12-31
Completion date
2020-06-25
Last updated
2020-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Monochorionic pregnancy, Twin to twin transfusion syndrome, Cervical pessary, Cervical length

Brief 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.

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.

Interventions

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.

Sponsors

Maternal-Infantil Vall d´Hebron Hospital
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER
Bürgerhospital Frankfurt
CollaboratorOTHER
Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Monochorionic twin pregnancies with severe TTTS requiring intrauterine surgery * Less than 26 weeks * Minimal age of 18 years * Informed consent signature

Exclusion criteria

* 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 * Death of both twins after the surgery * Monochorionic-monoamniotic twin pregnancy * Silicone allergy * Current participation in other RCT

Design outcomes

Primary

MeasureTime frameDescription
Delivery before 32 weeksWithin the first 15 days after deliveryRate of delivery before 32 weeks

Secondary

MeasureTime frameDescription
Fetal or neonatal deathWithin the first 15 days after the deathRate of intrauterine demise or neonatal death during the first 24 hours.
Neonatal morbidity30 days after the discharge from the hospitalRate of major adverse neonatal outcomes before discharge from the hospital.
Significant maternal adverse eventsWithin 15 days after discharge from the hospitalRate 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).
Physical or psychological intolerance to pessaryWithin 15 days after discharge from hospitalDiscomfort or pain due to the pessary that makes daily life uncomfortable (number of cases).
Preterm birth before 37 weeksWithin 15 days after deliveryRate of delivery before 36+6 weeks
Birth weightWithin the first 15 days after deliveryMedian weight (g) of the newborns at birth.
Hospitalisation for threatened preterm labour before 32 weeksWithin 15 days after deliveryRequirement of hospitalisation due to preterm contractions that need medical treatment to try to stop them before 31+6 weeks (rate).
Time to birthWithin 15 days after delivery
Preterm birth before 34 weeksWithin 15 days after deliveryrate of delivery before 33+6 weeks
Preterm birth before 30 weeksWithin 15 days after deliveryrate of delivery before 29+6 weeks
Preterm birth before 28 weeksWithin 15 days after deliveryrate of delivery before 27+6 weeks
Rupture of membranes before 32 weeksWithin 15 days after deliveryRupture of amniotic membranes before 31+6 weeks

Countries

Belgium, Germany, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026