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Interim analysis unfavorable to continue the study
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| Name | Class |
|---|---|
| Maternal-Infantil Vall d´Hebron Hospital | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| Bürgerhospital Frankfurt |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual management | No Intervention | Usual management of monochorionic pregnancy without the pessary placement | |
| Arabin Cervical Pessary | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arabin Cervical Pessary | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery before 32 weeks | Rate of delivery before 32 weeks | Within the first 15 days after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Birth weight | Median weight (g) of the newborns at birth. | Within the first 15 days after delivery |
| Fetal or neonatal death | Rate of intrauterine demise or neonatal death during the first 24 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Carreras, PhD | Hospital Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven. Campus Gasthuisberg | Leuven | 3000 | Belgium | |||
| Frauenklinik - Zentrum für Ultraschalldiagnostik und Pränatalmedizin Bürgerhospital und Clementine Kinderhospital gemeinnützige GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23055333 | Background | 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. | |
| 22475493 | Background |
| Label | URL |
|---|---|
| Arabin Cervical Pessary | View source |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D005330 | Fetofetal Transfusion |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER |
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|
| Within the first 15 days after the death |
| Neonatal morbidity | Rate of major adverse neonatal outcomes before discharge from the hospital. | 30 days after the discharge from the hospital |
| 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 |
| 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 |
| Preterm birth before 37 weeks | Rate of delivery before 36+6 weeks | Within 15 days after delivery |
| Rupture of membranes before 32 weeks | Rupture of amniotic membranes before 31+6 weeks | Within 15 days after delivery |
| 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 |
| Time to birth | Within 15 days after delivery |
| Preterm birth before 34 weeks | rate of delivery before 33+6 weeks | Within 15 days after delivery |
| Preterm birth before 30 weeks | rate of delivery before 29+6 weeks | Within 15 days after delivery |
| Preterm birth before 28 weeks | rate of delivery before 27+6 weeks | Within 15 days after delivery |
| Frankfurt |
| 60318 |
| Germany |
| University Medical Center Eppendorf | Hamburg | 20246 | Germany |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| 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. |
| 21305638 | Background | 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. |
| 23924878 | Background | 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. |
| 38036166 | Derived | Rodo C, Maiz N, Arevalo S, Lewi L, Couck I, Hollwitz B, Kyvernitakis I, Carreras E, Hecher K. The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2024 Aug;231(2):252.e1-252.e11. doi: 10.1016/j.ajog.2023.11.1245. Epub 2023 Nov 29. |
| 28764674 | Derived | 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. |
| D000091642 | Urogenital Diseases |
| D000751 | Anemia, Neonatal |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |