The Trial of Pessary After Laser for TTTS (PECEPLASER)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|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|
- Delivery before 32 weeks [ Time Frame: Within the first 15 days after delivery ] [ Designated as safety issue: No ]Rate of delivery before 32 weeks
- Birth weight [ Time Frame: Within the first 15 days after delivery ] [ Designated as safety issue: No ]Median weight (g) of the newborns at birth.
- Fetal or neonatal death [ Time Frame: Within the first 15 days after the death ] [ Designated as safety issue: No ]Rate of intrauterine demise or neonatal death during the first 24 hours.
- Neonatal morbidity [ Time Frame: 30 days after the discharge from the hospital ] [ Designated as safety issue: No ]Rate of major adverse neonatal outcomes before discharge from the hospital.
- Significant maternal adverse events [ Time Frame: Within 15 days after discharge from the hospital ] [ Designated as safety issue: No ]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).
- Physical or psychological intolerance to pessary [ Time Frame: Within 15 days after discharge from hospital ] [ Designated as safety issue: No ]Discomfort or pain due to the pessary that makes daily life uncomfortable (number of cases).
- Preterm birth before 37 weeks [ Time Frame: Within 15 days after delivery ] [ Designated as safety issue: No ]Rate of delivery before 36+6 weeks
- Rupture of membranes before 32 weeks [ Time Frame: Within 15 days after delivery ] [ Designated as safety issue: No ]Rupture of amniotic membranes before 31+6 weeks
- Hospitalisation for threatened preterm labour before 32 weeks [ Time Frame: Within 15 days after delivery ] [ Designated as safety issue: No ]Requirement of hospitalisation due to preterm contractions that need medical treatment to try to stop them before 31+6 weeks (rate).
- Time to birth [ Time Frame: Within 15 days after delivery ] [ Designated as safety issue: No ]
- Preterm birth before 34 weeks [ Time Frame: Within 15 days after delivery ] [ Designated as safety issue: No ]rate of delivery before 33+6 weeks
- Preterm birth before 30 weeks [ Time Frame: Within 15 days after delivery ] [ Designated as safety issue: No ]rate of delivery before 29+6 weeks
- Preterm birth before 28 weeks [ Time Frame: Within 15 days after delivery ] [ Designated as safety issue: No ]rate of delivery before 27+6 weeks
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
No Intervention: Usual management
Usual management of monochorionic pregnancy without the pessary placement
Arabin Cervical Pessary
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334489
|Contact: Carlota Rodo, MDemail@example.com|
|Contact: Elena Carreras, PhDfirstname.lastname@example.org|
|UZ Leuven. Campus Gasthuisberg||Not yet recruiting|
|Leuven, Belgium, 3000|
|Contact: Liesbeth Lewi, PhD +32 16 34 28 62 Liesbeth.Lewi@uzleuven.be|
|Contact: Isabel Couk, MD email@example.com|
|University Medical Center Eppendorf||Not yet recruiting|
|Hamburg, Germany, 20246|
|Contact: Kurt Hecher, PhD firstname.lastname@example.org|
|Contact: Bettina Hollowitz, MD +49-40-7410-20321 email@example.com|
|Hospital Universitari Vall d'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Carlota Rodo, MD 0034-934893072 firstname.lastname@example.org|
|Contact: Arevalo Silvia, MD 0034-934893072 email@example.com|
|Principal Investigator: Elena Carreras, PhD|
|Principal Investigator: Carlota Rodo, MD|
|Sub-Investigator: Silvia Arevalo, MD|
|Sub-Investigator: Anna Maroto, MD|
|Principal Investigator:||Elena Carreras, PhD||Hospital Universitari Vall d'Hebron|