TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence

Part of paid clinical trials in Houston, Texas.

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT02621645
Phase
PHASE4
Status
Recruiting
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Conditions

  • Twin Reversal Arterial Perfusion Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Early selective reduction of TRAP mass — PROCEDURE
    Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle
  • Late selective reduction of TRAP mass — PROCEDURE
    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 — DEVICE
  • Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle — DEVICE
  • 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 — DEVICE

Study Details

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.

Key Dates

Start date
May 31, 2016
Status verified
Jul 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Early intervention
    Intervention between 12.0 and 14.0 weeks. Early selective reduction of TRAP mass.
  • Active Comparator: 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.

Primary Outcome Measure

Number of patients with neonatal survival and birth at or after 34.0 weeks of the pump twin [ Time Frame: 2 weeks after expected date of birth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Memorial Hermann HospitalHoustonTexas-
Anthony Johnson
Noemi Boring

Find similar trials in Houston, TX

By research site
Children's Memorial Hermann Hospital· Houston, TX

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