Actively Recruiting
TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-10
126
Participants Needed
14
Research Sites
474 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
S
St. George's Hospital, University of London (UK sponsor)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- TRAP sequence diagnosed in a monochorionic diamniotic twin pregnancy between 11.6 and 13.6 weeks
- Women aged 18 years or older who can give consent
- Anatomically normal healthy (pump) twin
- Signed informed consent to participate in this trial
You will not qualify if you...
- Severe maternal medical condition or miscarriage risk preventing intervention
- Inaccessibility of the abnormal twin due to uterus position, obesity, fibroids, bowel, or placenta
- Major anomaly in the healthy twin requiring surgery or causing death or severe disability
- Spontaneous stop of abnormal blood flow or death of the healthy twin at diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Children's Memorial Hermann Hospital
Houston, Texas, United States
Actively Recruiting
2
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Graz, Austria
Actively Recruiting
3
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Actively Recruiting
4
Mount Sinai Hospital
Toronto, Canada
Actively Recruiting
5
Centre Médico-Chirurgical et Obstétrical
Schiltigheim, France
Actively Recruiting
6
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
7
Sheba Medical Center
Tel Litwinsky, Israel
Actively Recruiting
8
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
9
Ospedale dei Bambini Vittore Buzzi
Milan, Italy
Actively Recruiting
10
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
11
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
12
Birmingham Women's Hospital
Birmingham, United Kingdom
Actively Recruiting
13
King's College
London, United Kingdom
Actively Recruiting
14
St. George's Hospital, University of London (UK sponsor)
London, United Kingdom
Actively Recruiting
Research Team
I
Isabel Couck, MD
CONTACT
L
Liesbeth Lewi, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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