The Trial of Pessary After Laser for TTTS
- Conditions
- Premature Birth
- Interventions
- Device: Arabin Cervical Pessary
- Registration Number
- NCT01334489
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 352
- Monochorionic twin pregnancies with severe TTTS requiring intrauterine surgery
- Less than 26 weeks
- Minimal age of 18 years
- Informed consent signature
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arabin Cervical Pessary 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.
- Primary Outcome Measures
Name Time Method Delivery before 32 weeks Within the first 15 days after delivery Rate of delivery before 32 weeks
- Secondary Outcome Measures
Name Time Method Rupture of membranes before 32 weeks Within 15 days after delivery Rupture of amniotic membranes before 31+6 weeks
Preterm birth before 34 weeks Within 15 days after delivery rate of delivery before 33+6 weeks
Preterm birth before 28 weeks Within 15 days after delivery rate of delivery before 27+6 weeks
Birth weight Within the first 15 days after delivery Median weight (g) of the newborns at birth.
Preterm birth before 37 weeks Within 15 days after delivery Rate of delivery before 36+6 weeks
Fetal or neonatal death Within the first 15 days after the death Rate of intrauterine demise or neonatal death during the first 24 hours.
Neonatal morbidity 30 days after the discharge from the hospital Rate of major adverse neonatal outcomes before discharge from the hospital.
Significant maternal adverse events Within 15 days after discharge from the hospital 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).
Hospitalisation for threatened preterm labour before 32 weeks Within 15 days after delivery Requirement of hospitalisation due to preterm contractions that need medical treatment to try to stop them before 31+6 weeks (rate).
Preterm birth before 30 weeks Within 15 days after delivery rate of delivery before 29+6 weeks
Physical or psychological intolerance to pessary Within 15 days after discharge from hospital Discomfort or pain due to the pessary that makes daily life uncomfortable (number of cases).
Time to birth Within 15 days after delivery
Trial Locations
- Locations (4)
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
University Medical Center Eppendorf
🇩🇪Hamburg, Germany
UZ Leuven. Campus Gasthuisberg
🇧🇪Leuven, Belgium
Frauenklinik - Zentrum für Ultraschalldiagnostik und Pränatalmedizin Bürgerhospital und Clementine Kinderhospital gemeinnützige GmbH
🇩🇪Frankfurt, Germany