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

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.

Conditions

• Twin Reversal Arterial Perfusion Syndrome

Interventions

PROCEDURE

Early selective reduction of TRAP mass

Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle

PROCEDURE

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.

DEVICE

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

Sponsors & Collaborators

• St. George's Hospital, University of London (UK sponsor)

  collaborator UNKNOWN

• Leiden University Medical Center

  collaborator OTHER

• Ospedalo Maggiore Policlinico di Milano, Italy

  collaborator UNKNOWN

• Hospital Universitari Vall d'hebron Barcelona, Spain

  collaborator UNKNOWN

• Centro Médico-Chirurgical et Obstétrical (CMCO) Schiltigheim, France

  collaborator UNKNOWN

• Universitätsklinik für Frauenheilkunde und Geburtshilfe Graz, Austria

  collaborator UNKNOWN

• Ospedale dei Bambini "Vittore Buzzi" Milano, Italy

  collaborator UNKNOWN

• Birmingham Women's Hospital, UK

  collaborator UNKNOWN

• Sheba Medical Center

  collaborator OTHER_GOV

• Children's Memorial Hermann Hospital Houston Texas, USA

  collaborator UNKNOWN

• Universitätsklinikum Hamburg-Eppendorf, Germany

  collaborator UNKNOWN

• Mount Sinai Hospital, Canada

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University Hospital Innsbruck, Austria

  collaborator UNKNOWN

• Spedali Civili, University of Brescia, Italy

  collaborator UNKNOWN

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Liesbeth Lewi, MD PhD · UZ Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• United States
• Austria
• Belgium
• Canada
• France
• Germany
• Israel
• Italy
• Netherlands
• Spain
• United Kingdom

Study Locations