The Trial of Pessary After Laser for TTTS

Premature Birth Clinical Trial

— PECEPLASER  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01334489
• Other study ID #: PECEP_LASER Trial
• Status: Terminated
• Phase: N/A
• Start date: December 2012
• Est. completion date: June 25, 2020

Study information

• Verified date: August 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 352
• Est. completion date: June 25, 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Device:
• Arabin Cervical Pessary
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.

Locations

Country	Name	City	State
Belgium	UZ Leuven. Campus Gasthuisberg	Leuven
Germany	Frauenklinik - Zentrum für Ultraschalldiagnostik und Pränatalmedizin Bürgerhospital und Clementine Kinderhospital gemeinnützige GmbH	Frankfurt
Germany	University Medical Center Eppendorf	Hamburg
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Bürgerhospital Frankfurt, Maternal-Infantil Vall d´Hebron Hospital, Universitaire Ziekenhuizen Leuven, Universitätsklinikum Hamburg-Eppendorf

Countries where clinical trial is conducted

Belgium,  Germany,  Spain, 

References & Publications (4)

Carreras E, Arévalo S, Bello-Muñoz JC, Goya M, Rodó 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. — View 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. — View Citation

Goya M, Pratcorona L, Merced C, Rodó C, Valle L, Romero A, Juan M, Rodríguez A, Muñoz B, Santacruz B, Bello-Muñoz 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. Erratum in: Lancet. 2012 May 12;379(9828):1790. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery before 32 weeks	Rate of delivery before 32 weeks	Within the first 15 days after delivery
Secondary	Birth weight	Median weight (g) of the newborns at birth.	Within the first 15 days after delivery
Secondary	Fetal or neonatal death	Rate of intrauterine demise or neonatal death during the first 24 hours.	Within the first 15 days after the death
Secondary	Neonatal morbidity	Rate of major adverse neonatal outcomes before discharge from the hospital.	30 days after the discharge from the hospital
Secondary	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).	Within 15 days after discharge from the hospital
Secondary	Physical or psychological intolerance to pessary	Discomfort or pain due to the pessary that makes daily life uncomfortable (number of cases).	Within 15 days after discharge from hospital
Secondary	Preterm birth before 37 weeks	Rate of delivery before 36+6 weeks	Within 15 days after delivery
Secondary	Rupture of membranes before 32 weeks	Rupture of amniotic membranes before 31+6 weeks	Within 15 days after delivery
Secondary	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).	Within 15 days after delivery
Secondary	Time to birth		Within 15 days after delivery
Secondary	Preterm birth before 34 weeks	rate of delivery before 33+6 weeks	Within 15 days after delivery
Secondary	Preterm birth before 30 weeks	rate of delivery before 29+6 weeks	Within 15 days after delivery
Secondary	Preterm birth before 28 weeks	rate of delivery before 27+6 weeks	Within 15 days after delivery

External Links

•   Arabin Cervical Pessary