TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late intervention group (1:1), using a web-based application and a computer-generated list with random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention to treat.
Eligibility criteria
Qualifiers
TRAP sequence in a monochorionic diamniotic twin pregnancy diagnosed between 11.6 and 13.6 weeks, as determined by the crown-rump length of the pump twin in spontaneous conceptions and by the date of insemination or embryonic age at replacement in pregnancies resulting from subfertility treatment
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
Disqualifiers
Contraindication for an intervention due to a severe maternal medical condition or threatening miscarriage
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
Trial design
Treatments tested in this trial
- Early selective reduction of TRAP mass
- Late selective reduction of TRAP mass
- 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
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
St. George's Hospital, University of London (UK sponsor)
Collaborator
Leiden University Medical Center
Collaborator
Ospedalo Maggiore Policlinico di Milano, Italy
Collaborator
Hospital Universitari Vall d'hebron Barcelona, Spain
Collaborator
Centro Médico-Chirurgical et Obstétrical (CMCO) Schiltigheim, France
Collaborator
Universitätsklinik für Frauenheilkunde und Geburtshilfe Graz, Austria
Collaborator
Ospedale dei Bambini "Vittore Buzzi" Milano, Italy
Collaborator
Birmingham Women's Hospital, UK
Collaborator
Sheba Medical Center
Collaborator
Children's Memorial Hermann Hospital Houston Texas, USA
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
Mount Sinai Hospital, Canada
Collaborator
University of Pittsburgh
Collaborator
University Hospital Innsbruck, Austria
Collaborator
Spedali Civili, University of Brescia, Italy
Collaborator
Source ClinicalTrials.gov