Recruiting

TRAP Sequence

Sponsor:

Universitaire Ziekenhuizen KU Leuven

Code:

NCT02621645

Conditions

Twin Reversal Arterial Perfusion Syndrome

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early selective reduction of TRAP mass

Late selective reduction of TRAP mass

Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle

Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle

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

Study Details

Brief summary:

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

Twin Reversal Arterial Perfusion Syndrome

Study ID

NCT02621645

Start date

May, 2016

Status verified date

Jul, 2024

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early intervention

Intervention between 12.0 and 14.0 weeks. Early selective reduction of TRAP mass.

active comparator: Late intervention

Intervention between 16.0 and 19.0 weeks. Late selective reduction of TRAP mass. This is the standard timing of the intervention. One of two possible techniques for late reduction is chosen by the treating physician.

Interventions

Early selective reduction of TRAP mass

Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle

Late selective reduction of TRAP mass

Ultrasound-guided intrafetal ablation using a 17 Gauge to 20 Gauge needle OR fetoscopic 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. The treating physician can decide which technique will be used for the selective reduction.

Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle

Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle

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

Primary outcome measure

  • Number of patients with neonatal survival and birth at or after 34.0 weeks of the pump twin [ Time Frame: 2 weeks after expected date of birth ]

Central Contacts and Locations

Central contacts

Isabel Couck, MD

+32 16 342294isabel.couck@uzleuven.be

Liesbeth Lewi, MD PhD

+32 16 342862liesbeth.lewi@uzleuven.be

Locations

Children's Memorial Hermann Hospital

Recruiting

Houston, Texas, United States

Mount Sinai Hospital

Recruiting

Toronto, Canada

More Information

Sponsor

Universitaire Ziekenhuizen KU Leuven

Last update posted

Jul 10, 2024

Last verified

Jul, 2024

Keywords

  • monochorionic
  • TRAP
  • acardiac twin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven on 2024-07-10.