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

Status unconfirmed · Phase 4

Conditions studied: Twin Reversal Arterial Perfusion Syndrome

In brief

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 facts

Study ID

NCT02621645

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

126

Starts

2016-05-01

Expected to finish

2025-06-01

Last updated by the study team

2024-07-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Memorial Hermann Hospital — Houston, Texas, United States (enrolling)
• Universitätsklinik für Frauenheilkunde und Geburtshilfe — Graz, Austria (enrolling)
• Universitaire Ziekenhuizen Leuven — Leuven, Belgium (enrolling)
• Mount Sinai Hospital — Toronto, Canada (enrolling)
• Centre Médico-Chirurgical et Obstétrical — Schiltigheim, France (enrolling)
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Sheba Medical Center — Tel Litwinsky, Israel (enrolling)
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
• Ospedale dei Bambini Vittore Buzzi — Milan, Italy (enrolling)
• Leiden University Medical Center — Leiden, Netherlands (enrolling)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (enrolling)
• Birmingham Women's Hospital — Birmingham, United Kingdom (enrolling)
• King's College — London, United Kingdom (enrolling)
• St. George's Hospital, University of London (UK sponsor) — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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