Early vs Late Intervention for TRAP Syndrome
(TRAPIST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if early treatment for TRAP syndrome in twin pregnancies leads to better outcomes than the usual later treatment. TRAP syndrome is a rare condition in identical twin pregnancies where one twin (the acardiac twin) doesn't develop a heart, and the other twin (the pump twin) does all the work. The TRAP Intervention Study tests whether intervening between 12 and 14 weeks yields better results than the typical timing of 16 to 19 weeks. Women pregnant with monochorionic diamniotic twins (twins sharing a placenta but with separate amniotic sacs) diagnosed with TRAP sequence in the early weeks of pregnancy might be suitable candidates. As a Phase 4 trial, this study involves a treatment already FDA-approved and proven effective, aiming to understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for these treatments?
Research has shown that early treatment of TRAP syndrome—a condition in twins where one twin lacks a heart and the other must pump blood for both—might be safer than delaying intervention. Early treatments are less likely to fail and result in fewer cases of very early birth, before 32 weeks, indicating that early procedures are generally well-tolerated.
For later treatment, studies have indicated that methods like laser therapy and radiofrequency ablation (which uses energy waves to shrink tissue) are safe and reliable. These treatments are commonly used and have a good safety record.
Overall, both early and late treatments for TRAP syndrome appear safe, with early intervention possibly offering some benefits in terms of outcomes.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about this trial because it explores the timing of interventions for TRAP Syndrome, a condition typically managed by selective reduction of the TRAP mass. The trial compares early intervention, done between 12 to 14 weeks, with the standard late intervention, performed between 16 to 19 weeks. The early intervention approach could potentially prevent further complications by addressing the issue sooner, which might improve outcomes for patients. By investigating the timing of these interventions, researchers hope to find the most effective strategy for managing this condition, possibly leading to better health outcomes and fewer risks for those affected.
What evidence suggests that this trial's treatments could be effective for TRAP syndrome?
This trial will compare early intervention with late intervention for TRAP syndrome. Research has shown that starting treatment early for TRAP syndrome can lead to better results. Participants in the early intervention arm will receive treatment between 12 to 14 weeks of pregnancy, a timing that has increased the chances of a successful outcome. Early treatment stops blood flow to the non-viable twin sooner, protecting the healthy twin. Specifically, patients who received early treatment experienced fewer problems and better survival rates for the healthy twin. This evidence supports the idea that acting quickly can significantly impact managing TRAP syndrome.12456
Who Is on the Research Team?
Liesbeth Lewi, MD PhD
Principal Investigator
UZ Leuven
Are You a Good Fit for This Trial?
This trial is for women over 18 who can consent, with a monochorionic diamniotic twin pregnancy diagnosed with TRAP sequence between 11.6 and 13.6 weeks. The pump twin must be anatomically normal, and participants need to provide written informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Early Intervention
Early selective reduction of TRAP mass between 12.0 and 14.0 weeks
Late Intervention
Late selective reduction of TRAP mass between 16.0 and 19.0 weeks
Follow-up
Participants are monitored for fetal well-being and development after intervention
What Are the Treatments Tested in This Trial?
Interventions
- Early selective reduction of TRAP mass
- 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
- Late selective reduction of TRAP mass
- TRAP Intervention STudy
- Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle
- Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle
TRAP Intervention STudy is already approved in European Union, United States for the following indications:
- Twin Reversed Arterial Perfusion Sequence
- Twin Reversed Arterial Perfusion Sequence
Find a Clinic Near You
Who Is Running the Clinical Trial?
Universitaire Ziekenhuizen Leuven
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
Sheba Medical Center Tel-Hashomer, Israel
Collaborator
St. George's Hospital, University of London (UK sponsor)
Collaborator
Leiden University Medical Center
Collaborator
Ospedalo Maggiore Policlinico di Milano, Italy
Collaborator
Hospital Universitari Vall d'hebron Barcelona, Spain
Collaborator
Centro Médico-Chirurgical et Obstétrical (CMCO) Schiltigheim, France
Collaborator
Universitätsklinik für Frauenheilkunde und Geburtshilfe Graz, Austria
Collaborator
Ospedale dei Bambini "Vittore Buzzi" Milano, Italy
Collaborator