The TAPS Trial - Fetoscopic Laser Surgery for Twin Anemia Polycythemia Sequence
Status unconfirmed · Not applicable
Conditions studied: Twin Anemia Polycythemia Sequence
In brief
This multicenter open-label randomized controlled trial is set up to evaluate the effect of fetoscopic laser surgery on the gestational age at birth for monochorionic twin pregnancies diagnosed with twin anemia-polycythemia sequence. Half op the patients will be treated with fetoscopic laser surgery, while the other half will be managed with standard treatment. The hypothesis is that fetoscopic laser therapy will improve neonatal outcome by prolonging pregnancy.
Key facts
- Study ID
- NCT04432168
- Run by
- Leiden University Medical Center
- People needed
- 44
- Starts
- 2019-04-30
- Expected to finish
- 2024-04-30
- Last updated by the study team
- 2020-06-16
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Monochorionic twin pregnancy complicated by either spontaneous or post-laser twin anemia polycythemia sequence (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.
- Written informed consent to participate in this randomized controlled trial, forms being approved by the Ethical Committees.
You may not qualify if…
- TAPS stage 1
- TAPS stage≥ 2, diagnosed within 1 week after laser surgery for twin-twin transfusion syndrome (TTTS) (a large inter-twin middle cerebral artery peak systolic velocity difference within a week after laser for TTTS is likely to related to hemodynamic reequilibration, and is usually not based on TAPS)
- 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
Where it is running
- Vittore Buzzi Children's Hospital — Milan, Lombardy, Italy (enrolling)
- Leiden University Medical Center — Leiden, South Holland, Netherlands (enrolling)
- Vall d'Hebron University Hospital — Barcelona, Spain (enrolling)
- Yale University — New Haven, Connecticut, United States
- Karolinska University Hospital — Stockholm, Södermanland County, Sweden
Full record on ClinicalTrials.gov
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