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

PHASE4RecruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

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

Trial Locations (14)

Unknown

RECRUITING

Children's Memorial Hermann Hospital, Houston

RECRUITING

Universitätsklinik für Frauenheilkunde und Geburtshilfe, Graz

RECRUITING

Universitaire Ziekenhuizen Leuven, Leuven

RECRUITING

Mount Sinai Hospital, Toronto

RECRUITING

Centre Médico-Chirurgical et Obstétrical, Schiltigheim

RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Hamburg

RECRUITING

Sheba Medical Center, Tel Litwinsky

RECRUITING

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan

RECRUITING

Ospedale dei Bambini Vittore Buzzi, Milan

RECRUITING

Leiden University Medical Center, Leiden

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

RECRUITING

Birmingham Women's Hospital, Birmingham

RECRUITING

King's College, London

RECRUITING

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

All Listed Sponsors
collaborator

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

UNKNOWN

collaborator

Leiden University Medical Center

OTHER

collaborator

Ospedalo Maggiore Policlinico di Milano, Italy

UNKNOWN

collaborator

Hospital Universitari Vall d'hebron Barcelona, Spain

UNKNOWN

collaborator

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

UNKNOWN

collaborator

Universitätsklinik für Frauenheilkunde und Geburtshilfe Graz, Austria

UNKNOWN

collaborator

"Ospedale dei Bambini Vittore Buzzi Milano, Italy"

UNKNOWN

collaborator

Birmingham Women's Hospital, UK

UNKNOWN

collaborator

Sheba Medical Center

OTHER_GOV

collaborator

Children's Memorial Hermann Hospital Houston Texas, USA

UNKNOWN

collaborator

Universitätsklinikum Hamburg-Eppendorf, Germany

UNKNOWN

collaborator

Mount Sinai Hospital, Canada

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

University Hospital Innsbruck, Austria

UNKNOWN

collaborator

Spedali Civili, University of Brescia, Italy

UNKNOWN

lead

Universitaire Ziekenhuizen KU Leuven

OTHER