RecruitingNCT05008744

Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome

Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome (TTTS)


Sponsor

Seattle Children's Hospital

Enrollment

2,000 participants

Start Date

Oct 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to evaluate the use of diode laser photocoagulation of the communicating vessels in twin-to- twin transfusion syndrome (TTTS) with respect to maternal, fetal and neonatal outcomes.


Eligibility

Sex: FEMALE

Inclusion Criteria5

  • Single placenta (Monochorionic)
  • Polyhydramnios present in recipient twin (Greater than 8 cm maximum vertical pocket below 20 weeks and greater than a 10 cm pocket for greater than 20 weeks gestational age)
  • Oligohydramnios present in donor twin (Less than 2 cm maximum vertical pocket)
  • Prominent bladder in the recipient/ non-filling bladder in the donor
  • Thin dividing membrane

Exclusion Criteria5

  • Patients unwilling to participate in the study or to be followed up
  • Presence of major congenital anomalies incompatible with survival
  • Active pre-term labor Ruptured membranes
  • Chorioamnionitis
  • Vaginal bleeding

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Interventions

PROCEDUREFetoscopic laser ablation

Under ultrasound guidance, a 2 mm skin incision will be made and a 10Fr Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity. The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope.


Locations(2)

Seattle Childrens Hospital

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

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NCT05008744


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