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The TAPS Trial - Laser Surgery for Twin Anemia Polycythemia Sequence

The TAPS Trial: Fetoscopic Laser Surgery for Twin Anemia Polycythemia Sequence - a multicenter open-label randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26505
Enrollment
44
Registered
2018-01-15
Start date
2018-07-02
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Twin Anemia Polycythemia Sequence (Tweeling Anemie Polycythemie Sequentie) Monochorionic Twins (Monochoriale tweelingen) Feto-fetal transfusion syndrome (foeto-foetaal transfusiesyndroom) Fetoscopic Laser Surgery (Foetoscopische Laserchirurgie) Twin-to-Twin Transfusion Syndrome (Tweelingtransfusiesyndroom)

Interventions

In the experimental group fetoscopic laser surgery is performed, whereas the control group is treated with standard care (expectant management, IUT (with PET), selective feticide and/or preterm delive

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Monochorionic twin pregnancy complicated by either spontaneous or post-laser TAPS, stage ≥ 2, diagnosed between 20+0 and till 28+0 weeks of gestation • Women aged 18 years or more, who are able to consent.

Exclusion criteria

Exclusion criteria: • TAPS stage 1 • TAPS stage≥ 2, diagnosed within 1 week after laser surgery for TTTS* • Triplet pregnancies, or higher order multiple pregnancies • TAPS cases that already underwent an intrauterine treatment (with the exception of laser surgery for TTTS in post-laser TAPS cases) • Congenital abnormalities (including severe cerebral injury) in one or both twins

Design outcomes

Primary

MeasureTime frame
The primary outcome is gestational age at birth.

Secondary

MeasureTime frame
Secondary outcomes include: perinatal mortality or severe neonatal morbidity, hematological complication, procedure related complications and long-term neurodevelopmental outcome at 2 years.

Contacts

Public ContactL.S.A. Tollenaar

Leiden University Medical Center, Building 1, Room J-06-182

l.s.a.tollenaar@lumc.nl+31(0)71 52627488

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)