TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
NCT ID: NCT02621645
Last Updated: 2024-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
126 participants
INTERVENTIONAL
2016-05-31
2025-06-30
Brief Summary
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Detailed Description
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All interventions will be done under local anaesthesia and/or conscious sedation in sterile conditions by an experienced operator. They must be performed within 1 week after randomisation and at the latest at 14.0 weeks in the early group and 19.0 weeks in the late group. In the early group, only intrafetal coagulation will be used. Intrafetal ablation will be performed under ultrasound guidance using an 18-gauge (1.27 mm) to 20-gauge (0.91 mm) needle with a free-hand technique. The needle is introduced into the pelvis/abdomen of the TRAP mass close to the intra-abdominal portion of the feeding vessel, while avoiding puncture of the placenta and pump twin sac. The procedure is considered successful when there is complete cessation of reverse flow into the TRAP mass on intraoperative color-flow mapping.
In the late intervention/control group either intrafetal coagulation or fetoscopic laser coagulation will be performed of the cord and/or anastomosing vessels, unless the flow has stopped spontaneously or demise of the pump twin has occurred in the meantime. Intrafetal coagulation is done as described above by using a 17-gauge (1.47 mm) to 20-gauge needle. Alternatively, fetoscopic laser coagulation of the cord or anastomosing vessels can be performed through a 17-gauge to 7 French trocar with 1-1,3 mm fetoscope and 400 μm laser fiber. The rationale not to standardize the technique in the late intervention group is that several techniques have been reported for treatment after 16 weeks without any significant differences in outcome. Also, it is usual for the surgeon to adapt the technique to the requirements of each individual case, e.g. for a posterior placenta, the surgeon may prefer fetoscopic rather than intrafetal coagulation. Not restricting the technique to only 1 option will therefore more truly represent current practice and increase the generalizability of the trial's findings.
Patients will be discharged the same day or 1 day after the procedure. Management and follow-up will be similar for the study and the control or current practice group. A follow-up scan is usually performed 1 week after the intervention to check for fetal well-being and exclude anemia. A detailed ultrasound scan will be arranged in a fetal medicine center at 20 and 30 weeks to assess the heart and brain anatomy. Some centers may offer an MRI scan at around 30 weeks as part of the protocol for monochorionic twin pregnancies that underwent an intrauterine intervention. Antenatal, peripartum and postnatal care of the mother will be similar to that of a singleton pregnancy and at the discretion of the referring physician. Intrauterine intervention for TRAP sequence is not an indication for cesarean or elective preterm birth.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early intervention
Intervention between 12.0 and 14.0 weeks. Early selective reduction of TRAP mass.
Early selective reduction of TRAP mass
Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle
Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle
Late intervention
Intervention between 16.0 and 19.0 weeks. Late selective reduction of TRAP mass. This is the standard timing of the intervention. One of two possible techniques for late reduction is chosen by the treating physician.
Late selective reduction of TRAP mass
Ultrasound-guided intrafetal ablation using a 17 Gauge to 20 Gauge needle OR fetoscopic laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber. The treating physician can decide which technique will be used for the selective reduction.
Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle
Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber
Interventions
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Early selective reduction of TRAP mass
Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle
Late selective reduction of TRAP mass
Ultrasound-guided intrafetal ablation using a 17 Gauge to 20 Gauge needle OR fetoscopic laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber. The treating physician can decide which technique will be used for the selective reduction.
Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle
Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle
Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber
Eligibility Criteria
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Inclusion Criteria
* Women aged 18 years or more, who are able to consent
* Anatomically normal pump twin
* Provide written informed consent to participate in this randomized controlled trial, forms being approved by the Ethical Committees
Exclusion Criteria
* Inaccessibility of the acardiac twin due to a retroverted uterus, severe maternal obesity, uterine fibroids, bowel or placental superposition
* A major anomaly in the pump twin, requiring surgery or leading to infant death or severe handicap
* Spontaneous arrest of the reverse flow and/or pump twin demise at diagnosis
18 Years
FEMALE
No
Sponsors
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St. George's Hospital, University of London (UK sponsor)
UNKNOWN
Leiden University Medical Center
OTHER
Ospedalo Maggiore Policlinico di Milano, Italy
UNKNOWN
Hospital Universitari Vall d'hebron Barcelona, Spain
UNKNOWN
Centro Médico-Chirurgical et Obstétrical (CMCO) Schiltigheim, France
UNKNOWN
Universitätsklinik für Frauenheilkunde und Geburtshilfe Graz, Austria
UNKNOWN
Ospedale dei Bambini "Vittore Buzzi" Milano, Italy
UNKNOWN
Birmingham Women's Hospital, UK
UNKNOWN
Sheba Medical Center
OTHER_GOV
Children's Memorial Hermann Hospital Houston Texas, USA
UNKNOWN
Universitätsklinikum Hamburg-Eppendorf, Germany
UNKNOWN
Mount Sinai Hospital, Canada
OTHER
University of Pittsburgh
OTHER
University Hospital Innsbruck, Austria
UNKNOWN
Spedali Civili, University of Brescia, Italy
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Liesbeth Lewi, MD PhD
Role: STUDY_CHAIR
UZ Leuven
Locations
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Children's Memorial Hermann Hospital
Houston, Texas, United States
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Graz, , Austria
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Mount Sinai Hospital
Toronto, , Canada
Centre Médico-Chirurgical et Obstétrical
Schiltigheim, , France
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Sheba Medical Center
Tel Litwinsky, , Israel
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale dei Bambini Vittore Buzzi
Milan, , Italy
Leiden University Medical Center
Leiden, , Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Birmingham Women's Hospital
Birmingham, , United Kingdom
King's College
London, , United Kingdom
St. George's Hospital, University of London (UK sponsor)
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Anthony Johnson
Role: primary
Noemi Boring
Role: backup
Philipp Klaritsch
Role: primary
Liesbeth Lewi
Role: primary
Tim Van Mieghem
Role: primary
Greg Ryan
Role: backup
Romain Favre
Role: primary
Christian Bamberg
Role: primary
Yoav Yinon
Role: primary
Nicola Persico
Role: primary
Mariano Lanna
Role: primary
Dick Oepkes
Role: primary
Monique Haak
Role: backup
Carlota Rodo
Role: primary
Mark Kilby
Role: primary
Sarah Bower
Role: primary
Asma Khalil
Role: primary
Sarah Davies
Role: backup
References
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Moore TR, Gale S, Benirschke K. Perinatal outcome of forty-nine pregnancies complicated by acardiac twinning. Am J Obstet Gynecol. 1990 Sep;163(3):907-12. doi: 10.1016/0002-9378(90)91094-s.
Pagani G, D'Antonio F, Khalil A, Papageorghiou A, Bhide A, Thilaganathan B. Intrafetal laser treatment for twin reversed arterial perfusion sequence: cohort study and meta-analysis. Ultrasound Obstet Gynecol. 2013 Jul;42(1):6-14. doi: 10.1002/uog.12495.
Hecher K, Lewi L, Gratacos E, Huber A, Ville Y, Deprest J. Twin reversed arterial perfusion: fetoscopic laser coagulation of placental anastomoses or the umbilical cord. Ultrasound Obstet Gynecol. 2006 Oct;28(5):688-91. doi: 10.1002/uog.3816.
Chaveeva P, Poon LC, Sotiriadis A, Kosinski P, Nicolaides KH. Optimal method and timing of intrauterine intervention in twin reversed arterial perfusion sequence: case study and meta-analysis. Fetal Diagn Ther. 2014;35(4):267-79. doi: 10.1159/000358593. Epub 2014 Apr 16.
Lewi L, Valencia C, Gonzalez E, Deprest J, Nicolaides KH. The outcome of twin reversed arterial perfusion sequence diagnosed in the first trimester. Am J Obstet Gynecol. 2010 Sep;203(3):213.e1-4. doi: 10.1016/j.ajog.2010.04.018. Epub 2010 Jun 3.
O'Donoghue K, Barigye O, Pasquini L, Chappell L, Wimalasundera RC, Fisk NM. Interstitial laser therapy for fetal reduction in monochorionic multiple pregnancy: loss rate and association with aplasia cutis congenita. Prenat Diagn. 2008 Jun;28(6):535-43. doi: 10.1002/pd.2025.
Scheier M, Molina FS. Outcome of twin reversed arterial perfusion sequence following treatment with interstitial laser: a retrospective study. Fetal Diagn Ther. 2012;31(1):35-41. doi: 10.1159/000334156. Epub 2011 Dec 23.
Berg C, Holst D, Mallmann MR, Gottschalk I, Gembruch U, Geipel A. Early vs late intervention in twin reversed arterial perfusion sequence. Ultrasound Obstet Gynecol. 2014 Jan;43(1):60-4. doi: 10.1002/uog.12578.
Jelin E, Hirose S, Rand L, Curran P, Feldstein V, Guevara-Gallardo S, Jelin A, Gonzales K, Goldstein R, Lee H. Perinatal outcome of conservative management versus fetal intervention for twin reversed arterial perfusion sequence with a small acardiac twin. Fetal Diagn Ther. 2010;27(3):138-41. doi: 10.1159/000295176. Epub 2010 Mar 9.
Lewi L, Gratacos E, Ortibus E, Van Schoubroeck D, Carreras E, Higueras T, Perapoch J, Deprest J. Pregnancy and infant outcome of 80 consecutive cord coagulations in complicated monochorionic multiple pregnancies. Am J Obstet Gynecol. 2006 Mar;194(3):782-9. doi: 10.1016/j.ajog.2005.09.013.
Kerstjens JM, Nijhuis A, Hulzebos CV, van Imhoff DE, van Wassenaer-Leemhuis AG, van Haastert IC, Lopriore E, Katgert T, Swarte RM, van Lingen RA, Mulder TL, Laarman CR, Steiner K, Dijk PH. The Ages and Stages Questionnaire and Neurodevelopmental Impairment in Two-Year-Old Preterm-Born Children. PLoS One. 2015 Jul 20;10(7):e0133087. doi: 10.1371/journal.pone.0133087. eCollection 2015.
Other Identifiers
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S58224
Identifier Type: -
Identifier Source: org_study_id
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