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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Dec 2, 2015

Keywords

ClinConnect Summary

The TRAP Intervention Study is looking at the best timing for treating a condition called Twin Reversal Arterial Perfusion Syndrome (TRAP), which affects twin pregnancies where one twin is not developing properly. This clinical trial will compare two groups of pregnant women: one group will receive treatment early, between 12 to 14 weeks of pregnancy, and the other group will receive treatment later, between 16 to 19 weeks. The goal is to see if starting treatment earlier can lead to better outcomes for the healthy twin.

To participate in this study, women must be at least 18 years old, able to give consent, and have been diagnosed with TRAP in a specific type of twin pregnancy between 11.6 and 13.6 weeks. They should also have a normally developing twin, known as the "pump twin." Participants will be randomly assigned to either the early or late treatment group and will be monitored throughout the study. This research is important as it may help improve care for mothers and their twins facing this challenging condition.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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