Status:
TERMINATED
Amniotic Fluid Tandem Mass Spectrometry for Pregnancies Complicated by NIH and Severe Symmetrical IUGR
Lead Sponsor:
Obstetrix Medical Group
Conditions:
Hydrops Fetalis
Fetal Growth Retardation
Eligibility:
FEMALE
18-60 years
Brief Summary
The objective of this pilot study is to prospectively evaluate amniotic fluid of pregnancies complicated by non-immune hydrops and severe symmetrical intrauterine growth restriction by tandem mass spe...
Detailed Description
Nonimmune hydrops (NIH) and severe symmetrical intrauterine growth restriction (IUGR) represent two obstetrical circumstances that occur with relative frequency yet often escape adequate etiology asse...
Eligibility Criteria
Inclusion
- NIH
- Singleton gestation
- 18 years of age or older
- Excess extracellular fluid in at least two fetal sites as noted by ultrasound: abdomen (ascites), the chest (pleural and pericardial effusions), the skin (edema \> 5mm), the amniotic cavity (polyhydramnios), and the placenta (thickening \> 6cm)
- NIH diagnosis \> 15w0d gestation
- Diagnostic amniocentesis performed at \> 15w0d gestation
- NIH
Exclusion
- Immune-mediated hydrops fetalis as diagnosed by maternal red cell antigens and fetal anemia suspected by middle cerebral artery doppler ultrasound and/or confirmed by percutaneous umbilical blood sampling
- Structural anomaly identified by ultrasound
- Chromosomal aneuploidy
- Multiple gestations
- IUGR Inclusion Criteria:
- Singleton gestation
- 18 years of age or older
- Severe symmetrical IUGR defined as a \> 3 week lag of all fetal ultrasound measurements (biparietal diameter, head circumference, abdominal circumference, and femur length)
- IUGR diagnosis between 24-32 weeks gestation
- Diagnostic amniocentesis performed prior to 32 weeks gestation
- IUGR
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00143039
Start Date
March 1 2006
End Date
August 1 2009
Last Update
December 19 2014
Active Locations (11)
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1
Banner Good Sammaritan Hospital
Phoenix, Arizona, United States, 85006
2
Banner Desert Samaritan Hospital
Phoenix, Arizona, United States, 85202
3
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
4
Long Beach Memorial Medical Center
Long Beach, California, United States, 90801-1428