Twin Anemia Polycythemia Sequence Clinical Trial
Official title:
The TAPS Trial - Fetoscopic Laser Surgery for Twin Anemia-Polycythemia Sequence - a Multicenter Open-Label Randomized Controlled Trial
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.
Rationale: Monochorionic twins share one placenta and are connected to each other via
vascular anastomoses at the placental surface, allowing the blood to transfer
bi-directionally between the two fetuses. Unbalanced inter-twin blood transfusion can result
in twin anemia-polycythemia sequence (TAPS). Management options include: fetoscopic laser
surgery, intrauterine blood transfusion (IUT) with or without partial exchange transfusion
(PET), preterm delivery, selective feticide and expectant management. The optimal treatment
for TAPS is not clear. Fetoscopic laser surgery is the only causative treatment option, but
data on the feasibility of this procedure are mainly based on case reports and small cohort
studies. A large randomized controlled trial is needed to evaluate the possible beneficial
effect of fetoscopic laser surgery and to determine the optimal treatment option for TAPS.
Objective: The aim of this trial is to investigate whether fetoscopic laser surgery improves
the outcome for TAPS twins as compared to the control group (standard care consisting of
expectant management, IUT, preterm delivery). The hypothesis is that fetoscopic laser therapy
will improve neonatal outcome by prolonging pregnancy.
Study design: International multi-centered open-label randomized controlled trial to assess
whether fetoscopic laser surgery (experimental group) improves the outcome of TAPS twins
compared to standard care (control group).
Study population: Monochorionic twin pregnancies with TAPS stage ≥ 2 (spontaneous or
post-laser) diagnosed between 20 and 28 weeks of gestation.
Intervention: 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 delivery, depending on the opinion of the fetal surgeon).
Main study endpoints: The primary outcome is gestational age at birth. Secondary outcomes
include: perinatal mortality or severe neonatal morbidity, hematological complication,
procedure related complications and long-term neurodevelopmental outcome at 2 years.
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