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Search / Trial NCT01622049

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

Launched by UNIVERSITY OF SOUTH FLORIDA · Jun 13, 2012

Trial Information

Current as of May 28, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria
  • To be eligible, patients must meet the following criteria:
  • 1. Maternal age 18 to 55 years
  • 2. Gestational age: 16 weeks, 0 days to 26 weeks, 0 days.
  • 3. Confirmed TTTS patients, who by definition meet the following sonographic criteria:
  • 1. Single placenta.
  • 2. Polyhydramnios: maximum vertical pocket \>= 8 cm in the recipient twin, prior to amniodrainage.
  • 3. Oligohydramnios: maximum vertical pocket \<=2 cm in the donor twin, prior to amniodrainage.
  • 4. Thin dividing membrane (absence of twin peak sign) or absence of dividing membrane (monoamniotic).
  • 5. Same gender, if visible.
  • 4. Patients choosing laser therapy that have undergone prior therapeutic amniocentesis may be included.
  • 5. Patients with an anterior placenta may be included.
  • 6. Triplet gestations with two or three fetuses sharing the same placenta may be included.
  • 7. Patients must be able to give written informed consent. Inclusion Criteria 5.2 Exclusion Criteria
  • The following criteria would exclude patients from participation in the study:
  • 1. Patients unable or unwilling to participate in the study or to be followed up.
  • 2. Patients unable to give written informed consent.
  • 3. Presence of major congenital anomalies that may not warrant surgery.
  • 4. Known unbalanced chromosomal complement.
  • 5. Prior intentional septostomy (purposely making a hole in the dividing membrane).
  • 6. Ruptured membranes.
  • 7. Chorioamnionitis.
  • 8. Abnormal intracranial ultrasound findings of either fetus to include, but not limited to: intraventricular hemorrhage, porencephalic cysts, hydrocephalus, Dandy-Walker syndrome, holoprosencephaly and agenesis of the corpus callosum. Isolated ventriculomegaly (atrium 10-19 mm) may or may not be used an exclusion criteria.
  • 9. Placental abruption.
  • 10. Active labor.
  • 11. Jehovah's Witness.
  • 12. Any other patient deemed inappropriate for the study by the principal investigator.

About University Of South Florida

The University of South Florida (USF) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong commitment to improving patient outcomes, USF leverages its diverse faculty expertise and state-of-the-art facilities to conduct rigorous and ethically sound research. The university fosters collaboration across disciplines, engaging in partnerships that enhance the translation of scientific discoveries into effective therapeutic interventions. USF's clinical trial programs are designed to address pressing health challenges and contribute to the body of knowledge in various medical fields, ultimately aiming to benefit communities and improve public health.

Locations

Tampa, Florida, United States

Patients applied

0 patients applied

Trial Officials

Ruben A Quintero, MD

Principal Investigator

University of South Florida

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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