RECRUITING

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

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Conditions

Twin Reversal Arterial Perfusion SyndromemonochorionicTRAPacardiac twin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence: an Open-label Randomized Controlled Trial: TRAPIST - TRAP Intervention STudy

Quick Facts

Study Start:2016-05
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02621645

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Women aged 18 years or more, who are able to consent
  3. * Anatomically normal pump twin
  4. * Provide written informed consent to participate in this randomized controlled trial, forms being approved by the Ethical Committees
  1. * Contraindication for an intervention due to a severe maternal medical condition or threatening miscarriage
  2. * Inaccessibility of the acardiac twin due to a retroverted uterus, severe maternal obesity, uterine fibroids, bowel or placental superposition
  3. * A major anomaly in the pump twin, requiring surgery or leading to infant death or severe handicap
  4. * Spontaneous arrest of the reverse flow and/or pump twin demise at diagnosis

Contacts and Locations

Study Contact

Isabel Couck, MD
CONTACT
+32 16 342294
isabel.couck@uzleuven.be
Liesbeth Lewi, MD PhD
CONTACT
+32 16 342862
liesbeth.lewi@uzleuven.be

Principal Investigator

Liesbeth Lewi, MD PhD
STUDY_CHAIR
UZ Leuven

Study Locations (Sites)

Children's Memorial Hermann Hospital
Houston, Texas
United States

Collaborators and Investigators

Sponsor: Universitaire Ziekenhuizen KU Leuven

  • Liesbeth Lewi, MD PhD, STUDY_CHAIR, UZ Leuven

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-05
Study Completion Date2025-06

Study Record Updates

Study Start Date2016-05
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • monochorionic
  • TRAP
  • acardiac twin

Additional Relevant MeSH Terms

  • Twin Reversal Arterial Perfusion Syndrome