Randomized Clinical Trial: Expectant Management vs Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation and Absent or Reverse Diastolic Flow in the Umbilical Artery
Launched by UNIVERSITY OF SOUTH FLORIDA · Aug 6, 2010
Trial Information
Current as of April 24, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Gestational age 16--24 weeks
- • Sonographic evidence of monochorionicity: single placenta, same gender, absent twin-peak sign
- • Diagnosis of IUGR present in one twin (fetal weight at or below the 10th percentile for gestational age)
- • Persistent absent or reverse-end diastolic flow in the umbilical artery in the SIUGR twin
- • Able to provide written informed consent
- Exclusion Criteria:
- • Patients unwilling to participate in the study, provide consent, or to be followed up
- • Presence of twin-twin transfusion syndrome (TTTS) defined as a maximum vertical pocket (MVP) of ≤2 cm in one sac and MVP of ≥8 cm in the other sac.
- • Presence of major congenital anomalies (anencephaly, acardia, spina bifida) or intracranial findings in either twin: IVH, porencephalic cysts, ventriculomegaly or other findings suggestive of brain damage.
- • Both twins are \<10th percentile
- • Diastolic flow or intermittently absent end-diastolic flow in the umbilical artery in the SIUGR twin
- • Unbalanced chromosomal complement (if known).
- • Ruptured or detached membranes
- • Placental abruption
- • Chorioamnionitis
- • Triplets
- • Active labor
- • Jehovah's witness
- • Any other patient deemed inappropriate for the study by the principal investigator
- • Placenta previa
Trial Officials
Ruben A Quintero, MD
Principal Investigator
University of South Florida
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampa, Florida, United States
Los Angeles, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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