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Compares treatment options for Twin Reversal Arterial Perfusion Syndrome
Official title TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
ClinicalTrials.gov ID: NCT02621645
What this study is testing
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- Women aged 18 years or more, who are able to consent
- Anatomically normal pump twin
- Provide written informed consent to participate in this assigned by chance controlled trial, forms being approved by the Ethical Committees
You likely can't join 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Graz, Austria
- Leuven, Belgium
- Toronto, Canada
- Schiltigheim, France
- Hamburg, Germany
- Tel Litwinsky, Israel
- Milan, Italy
- Leiden, Netherlands
- Barcelona, Spain
- Birmingham, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Graz, Austria; Leuven, Belgium; Toronto, Canada; Schiltigheim, France; Hamburg, Germany and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.