Clinical trial NCT01334489: The Trial of Pessary After Laser for TTTS
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Birth
Keywords: Monochorionic pregnancy
Twin to twin transfusion syndrome
Cervical pessary
Cervical length
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Maternal-Infantil Vall d´Hebron Hospital
name: Universitaire Ziekenhuizen KU Leuven
name: Universitätsklinikum Hamburg-Eppendorf
name: Bürgerhospital Frankfurt
First posted: 2011-04-13
Enrollment: 352
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delivery before 32 weeks
timeFrame: Within the first 15 days after delivery
Secondary outcomes:
measure: Birth weight
timeFrame: Within the first 15 days after delivery
measure: Fetal or neonatal death
timeFrame: Within the first 15 days after the death
measure: Neonatal morbidity
timeFrame: 30 days after the discharge from the hospital
measure: Significant maternal adverse events
timeFrame: Within 15 days after discharge from the hospital
measure: Physical or psychological intolerance to pessary
timeFrame: Within 15 days after discharge from hospital
measure: Preterm birth before 37 weeks
timeFrame: Within 15 days after delivery
measure: Rupture of membranes before 32 weeks
timeFrame: Within 15 days after delivery
measure: Hospitalisation for threatened preterm labour before 32 weeks
timeFrame: Within 15 days after delivery
measure: Time to birth
timeFrame: Within 15 days after delivery
measure: Preterm birth before 34 weeks
timeFrame: Within 15 days after delivery
measure: Preterm birth before 30 weeks
timeFrame: Within 15 days after delivery
measure: Preterm birth before 28 weeks
timeFrame: Within 15 days after delivery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven. Campus Gasthuisberg
city: Frankfurt
country: Germany
facility: Frauenklinik - Zentrum für Ultraschalldiagnostik und Pränatalmedizin Bürgerhospital und Clementine Kinderhospital gemeinnützige GmbH
city: Hamburg
country: Germany
facility: University Medical Center Eppendorf
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Elena Carreras, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Goya 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.
citation: Liem 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.
citation: Rodo 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.