Early versus late intervention for twin reversed arterial perfusion sequence: an open-label randomized controlled trial *TRAPIST*: TRAP Intervention STudy

Recruiting

• Conditions: TRAP acardiacus / alive fetus with no heart - TRAP pump twin/ twin giving blood to demised co twin; 10016849

• Registration Number: NL-OMON43488
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

MCDA twin pregnancy
Complicated by TRAP sequency diagnosed between 11+6 and 13+6 weeks AD
Anatomically normal pump twin
Age > 18
Informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pump twin neonatal survival and birth at or after 34.0 weeks. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Need for re-intervention, maternal morbidity, gestational age at birth,<br /><br>neonatal outcome, 2-year neurodevelopmental outcome</p><br>