Status:
COMPLETED
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
Lead Sponsor:
University of South Florida
Conditions:
Intrauterine Growth Retardation
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic twins typically affects on...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01177553
Start Date
May 1 2007
End Date
February 1 2009
Last Update
February 21 2013
Active Locations (2)
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1
University of Southern California
Los Angeles, California, United States, 90089
2
University of South Florida
Tampa, Florida, United States, 33606