The TAPS Trial - Fetoscopic Laser Surgery for Twin Anemia Polycythemia Sequence
NCT ID: NCT04432168
Last Updated: 2020-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
44 participants
INTERVENTIONAL
2019-04-30
2024-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fetoscopic Laser Surgery
fetoscopic laser coagulation of the vascular anastomoses at the placental surface
Fetoscopic Laser Surgery
Fetoscopic Photocoagulation of the connecting vascular anastomoses on the surface of the placenta.
Standard Treatment
Expectant management, IUT (with or without PET), preterm delivery
Standard Treatment
In the control group, the choices of treatment include expectant management, intrauterine transfusion (IUT) (with or without partial exchange transfusion (PET)) or preterm delivery, depending on the judgment of the fetal surgeon with regard to the gestational age and state of the disease.
* Expectant management will consist of close monitoring with ultrasound including Doppler measurements of the middle cerebral artery peak systolic velocity (MCA-PSV), at least every week.
* IUT: the intrauterine infusion of red blood cells into the circulation of the donor twin treat anemia.
* PET: the intrauterine infusion of saline into the circulation of the recipient twin to treat polycythemia.
* Preterm delivery: Induction of labor or cesarean section before 36 weeks of gestation.
Interventions
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Fetoscopic Laser Surgery
Fetoscopic Photocoagulation of the connecting vascular anastomoses on the surface of the placenta.
Standard Treatment
In the control group, the choices of treatment include expectant management, intrauterine transfusion (IUT) (with or without partial exchange transfusion (PET)) or preterm delivery, depending on the judgment of the fetal surgeon with regard to the gestational age and state of the disease.
* Expectant management will consist of close monitoring with ultrasound including Doppler measurements of the middle cerebral artery peak systolic velocity (MCA-PSV), at least every week.
* IUT: the intrauterine infusion of red blood cells into the circulation of the donor twin treat anemia.
* PET: the intrauterine infusion of saline into the circulation of the recipient twin to treat polycythemia.
* Preterm delivery: Induction of labor or cesarean section before 36 weeks of gestation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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DickOepkes
Prof. dr. D. Oepkes
Principal Investigators
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Dick Oepkes, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
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Yale University
New Haven, Connecticut, United States
Vittore Buzzi Children's Hospital
Milan, Lombardy, Italy
Leiden University Medical Center
Leiden, South Holland, Netherlands
Vall d'Hebron University Hospital
Barcelona, , Spain
Karolinska University Hospital
Stockholm, Södermanland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Ozan Bahtiyar, MD PhD
Role: primary
References
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Lopriore E, Middeldorp JM, Oepkes D, Kanhai HH, Walther FJ, Vandenbussche FP. Twin anemia-polycythemia sequence in two monochorionic twin pairs without oligo-polyhydramnios sequence. Placenta. 2007 Jan;28(1):47-51. doi: 10.1016/j.placenta.2006.01.010. Epub 2006 Mar 3.
Robyr R, Lewi L, Salomon LJ, Yamamoto M, Bernard JP, Deprest J, Ville Y. Prevalence and management of late fetal complications following successful selective laser coagulation of chorionic plate anastomoses in twin-to-twin transfusion syndrome. Am J Obstet Gynecol. 2006 Mar;194(3):796-803. doi: 10.1016/j.ajog.2005.08.069.
Sananes N, Veujoz M, Severac F, Barthoulot M, Meyer N, Weingertner AS, Kohler M, Guerra F, Gaudineau A, Nisand I, Favre R. Evaluation of the Utility of in utero Treatment of Twin Anemia-Polycythemia Sequence. Fetal Diagn Ther. 2015;38(3):170-8. doi: 10.1159/000380822. Epub 2015 Mar 17.
Slaghekke F, Favre R, Peeters SH, Middeldorp JM, Weingertner AS, van Zwet EW, Klumper FJ, Oepkes D, Lopriore E. Laser surgery as a management option for twin anemia-polycythemia sequence. Ultrasound Obstet Gynecol. 2014 Sep;44(3):304-10. doi: 10.1002/uog.13382. Epub 2014 Aug 4.
Other Identifiers
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NL6442700018
Identifier Type: -
Identifier Source: org_study_id
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