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

ConditionTwin Reversal Arterial Perfusion Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early selective reduction of TRAP mass

    Procedure/Surgery

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

  • Late selective reduction of TRAP mass

    Procedure/Surgery

    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

    Device

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

    Device

  • 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

    Device

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Early interventionExperimental treatment 2 interventions
Group B: Late interventionActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Number of patients with need for re-intervention

This means any kind of fetal intervention, such as repeated intrafetal coagulation, intra-uterine transfusion cord-occlusion...

Time frame
2 weeks after expected date of birth
2

Number of patients with maternal morbidity

Maternal morbidity is defined as presence of one or more of the following events: * Need for transfusion for hemorrhage * Abruption * Chorioamnionitis as defined on pathology * Sepsis * Bowel perforation * Other serious maternal morbidity requiring admission to ICU

Time frame
2 weeks after expected date of birth
3

Number of patients with miscarriage

Number of patients with miscarriage before 24 weeks

Time frame
2 weeks after expected date of birth
4

Number of patients with preterm prelabor rupture of membranes (PPROM)

Number of patients with rupture of membranes before onset of labor and before 37 weeks

Time frame
2 weeks after expected date of birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

St. George's Hospital, University of London (UK sponsor)

Collaborator

Leiden University Medical Center

Collaborator

Ospedalo Maggiore Policlinico di Milano, Italy

Collaborator

Hospital Universitari Vall d'hebron Barcelona, Spain

Collaborator

Centro Médico-Chirurgical et Obstétrical (CMCO) Schiltigheim, France

Collaborator

Universitätsklinik für Frauenheilkunde und Geburtshilfe Graz, Austria

Collaborator

Ospedale dei Bambini "Vittore Buzzi" Milano, Italy

Collaborator

Birmingham Women's Hospital, UK

Collaborator

Sheba Medical Center

Collaborator

Children's Memorial Hermann Hospital Houston Texas, USA

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator

Mount Sinai Hospital, Canada

Collaborator

University of Pittsburgh

Collaborator

University Hospital Innsbruck, Austria

Collaborator

Spedali Civili, University of Brescia, Italy

Collaborator

Source ClinicalTrials.gov
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