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The TAPS Trial - Fetoscopic Laser Surgery for Twin Anemia Polycythemia Sequence

NCT04432168 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-06-16

No results posted yet for this study

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 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.

Conditions

  • Twin Anemia Polycythemia Sequence

Interventions

PROCEDURE

Fetoscopic Laser Surgery

Fetoscopic Photocoagulation of the connecting vascular anastomoses on the surface of the placenta.

OTHER

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.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Dick Oepkes, MD PhD · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2022-04-30
Completion
2024-04-30

Countries

  • United States
  • Italy
  • Netherlands
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04432168 on ClinicalTrials.gov