TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence: an Open-label Randomized Controlled Trial: TRAPIST - TRAP Intervention STudy
Universitaire Ziekenhuizen KU Leuven
126 participants
May 1, 2016
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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
Exclusion Criteria4
- 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
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Interventions
Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle
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.
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT02621645