Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence: an Open-label Randomized Controlled Trial: TRAPIST - TRAP Intervention STudy
Universitaire Ziekenhuizen KU Leuven
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.
Description
The investigators propose to conduct a 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 11.6 and 13.6 weeks (1:1) to an early or late intervention group, using a web-based application (www.sealedenvelope.com) with a computer-generated list with random permuted blocks of sizes 2 or 4, stratified by gestational age at inclusion (11.6 -…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Contraindication for an interventi…
Interventions
- ProcedureEarly selective reduction of TRAP mass
Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle
- ProcedureLate 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.
- DeviceUltrasound-guided intrafetal ablation using a 18 to 20 Gauge needle
- DeviceUltrasound-guided intrafetal ablation using a 17 to 20 Gauge needle
- DeviceLaser 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
Locations (14)
- Children's Memorial Hermann HospitalHouston, Texas
- Universitätsklinik für Frauenheilkunde und GeburtshilfeGraz
- Universitaire Ziekenhuizen LeuvenLeuven
- Mount Sinai HospitalToronto
- Centre Médico-Chirurgical et ObstétricalSchiltigheim
- Universitätsklinikum Hamburg-EppendorfHamburg