Status:
UNKNOWN
The TAPS Trial - Fetoscopic Laser Surgery for Twin Anemia Polycythemia Sequence
Lead Sponsor:
Leiden University Medical Center
Conditions:
Twin Anemia Polycythemia Sequence
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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 fet...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04432168
Start Date
April 30 2019
End Date
April 30 2024
Last Update
June 16 2020
Active Locations (5)
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1
Yale University
New Haven, Connecticut, United States, 208327
2
Vittore Buzzi Children's Hospital
Milan, Lombardy, Italy, 20154
3
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA
4
Vall d'Hebron University Hospital
Barcelona, Spain, 08035