Status:
COMPLETED
Doppler or Amniocentesis to Predict Fetal Anemia
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Stichting Oranjekliniek, The Netherlands
Conditions:
Rh Isoimmunization
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
In pregnancies complicated by Rhesus disease, the mother has developed antibodies which cross the placenta and can cause anemia and death of the fetus. When the anemia is detected on time, the fetus c...
Detailed Description
In pregnancies complicated by red cell alloimmunization, the fetus may suffer from chronic progressive hemolytic anemia. Severe fetal anemia leading to hydrops and fetal demise can occur as early as 1...
Eligibility Criteria
Inclusion
- Pregnant women with red cell alloimmunization associated with a risk of fetal anemia (D, E, c or Duffy (Fya )antibodies, alone or in combination with other antibodies)
- Gestational age between 12 and 34 weeks at study entry, viable fetus and accurate dating
- Maternal serum test-result, above the threshold at which the fetus is considered to be at risk of developing hemolytic anemia and thus a potential candidate for invasive testing.
Exclusion
- Presence of Kell-antibodies
- Presence of fetal hydrops at first ultrasonographic examination
- Major fetal congenital or chromosomal anomalies
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00295516
Start Date
October 1 2000
End Date
August 1 2004
Last Update
May 24 2006
Active Locations (1)
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1
Mt. Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5