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Amniotic Fluid Tandem Mass Spectrometry for Pregnancies Complicated by NIH and Severe Symmetrical IUGR (TandemMS)
This study is currently recruiting participants.
Verified by Obstetrix Medical Group, March 2008
Sponsored by: Obstetrix Medical Group
Information provided by: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT00143039
  Purpose

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 spectrometry for inborn errors of metabolism.


Condition Intervention Phase
Hydrops Fetalis
Fetal Growth Retardation
Procedure: Tandem MS test for inborn errors of metabolism
Phase I

Genetics Home Reference related topics: beta thalassemia
MedlinePlus related topics: Edema
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Amniotic Fluid Tandem Mass Spectrometry for Pregnancies Complicated by Nonimmune Hydrops and Severe Symmetrical Intrauterine Growth Restriction-A Multicenter Prospective Pilot Cohort Study

Further study details as provided by Obstetrix Medical Group:

Primary Outcome Measures:
  • Will assess whether amniotic fluid tandem mass spectrometry results are valid when compared to neonatal blood samples for normal pregnancies and those pregnancies complicated by NIH and severe symmetrical IUGR. [ Time Frame: comparrison down with in 2 days of life. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Will include OB complications and neonatal outcomes of pregnancies complicated by NIH and severe symmetrical IUGR. [ Time Frame: during the neonatal period ] [ Designated as safety issue: No ]
  • Review of the medical records and neonatal RDS database queries will be used to evaluate these variables. [ Time Frame: during neonatal period ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 82
Study Start Date: March 2006
Estimated Study Completion Date: October 2008
Groups/Cohorts Assigned Interventions
NIH/SSIUGR fetuses
Group 1 includes pregnancies complicated by a fetus with either Non-Immune Hydrops or Severe Symmetrical IUGR.
Procedure: Tandem MS test for inborn errors of metabolism
Tandem MS spectrometry test will be done on all maternal blood, amniotic fluid and newborn blood samples for both groups.
Control-Normal fetus
Group 2 includes all normally appearing fetuses on U/S who will be having a diagnostic amniocentesis as part of their routine care.
Procedure: Tandem MS test for inborn errors of metabolism
Tandem MS spectrometry test will be done on all maternal blood, amniotic fluid and newborn blood samples for both groups.

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 assessment and diagnosis prior to and after birth. Both of these conditions have high perinatal and neonatal mortality rates. While antepartum ultrasound and amniotic fluid evaluations of fetal karyotype and viral DNA studies diagnose some etiologies for NIH and severe symmetrical IUGR, large percentages of NIH (30-40%) and IUGR (20-30%) cases are attributed to idiopathic causes. Because of this uncertainty in diagnosis, many cases are subjected to prolonged antepartum hospitalization with intensive fetal monitoring and urgent delivery by Cesarean section for non-reassuring fetal status, only to succumb to a neonatal demise in the nursery. A small percentage (1-2%) of these cases are found to be due to inborn errors of metabolism by neonatal and/or postmortem evaluation; however, when combined together, greater than 50% of NIH and IUGR cases have no identifiable etiology. Therefore, any new test that may make a diagnosis for NIH or severe symmetrical IUGR prior to delivery would be extremely important to the management of both the mother and the infant. Tandem mass spectrometry for inborn errors of metabolism may represent a new tool for assessing, identifying, and treating currently unexplained cases of NIH and severe symmetrical IUGR.

This is a prospective pilot cohort study of all pregnancies complicated by NIH and severe symmetrical IUGR within the Pediatrix-Obstetrix network. This network encompasses several perinatal sites throughout the United States with corresponding neonatal intensive care units utilizing a computerized patient database (RDS). The objective of this study is to prospectively evaluate amniotic fluid of pregnancies complicated by NIH and severe symmetrical IUGR by a method called tandem mass spectrometry for inborn errors of metabolism.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnancies complicated by NIH or SSIUGR fetuses as compared to a control group of pregnancies with normally appearing fetuses requiring a diagnostic amniocentesis as part of her care.

Criteria

NIH Inclusion Criteria:

  • 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 Criteria:

  • 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 Exclusion Criteria:

  • Asymmetrical IUGR
  • Structural anomaly identified by ultrasound
  • Chromosomal aneuploidy
  • Multiple gestations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143039

Contacts
Contact: Kimberly A Maurel, RN, MSN, CNS 714-593-9171 kimberly_maurel@pediatrix.com
Contact: Diana Abril, RN, BSN 480-65--8644 diana_abril@pediatrix.com

Locations
United States, Arizona
Banner Good Sammaritan Hospital Recruiting
Phoenix, Arizona, United States, 85006
Contact: Karrie Francois, MD     480-969-5999 ext 201     karrie_Francois@pediatrix.com    
Contact: Melissa Ingersoll, RN            
Principal Investigator: Karrie Francois, MD            
Banner Desert Samaritan Hospital Recruiting
Phoenix, Arizona, United States, 85202
Contact: Melissa Ingersoll, RN     602-239-3632     melissa_ingersoll@pediatrix.com    
Principal Investigator: Karrie Francious, MD            
United States, California
Good Samaritan Hospital Recruiting
San Jose, California, United States, 95124
Contact: Andrew Combs, MD     408-371-7111     andrew_combs@pediatrix.com    
Principal Investigator: Andrew Combs, MD            
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90801-1428
Contact: Katherine Berkowitz, MD     562-933-2730     katherine_berkowitz@pediatrix.com    
Principal Investigator: Katherine Berkowitz, MD            
Saddleback Memorial Medical Center Not yet recruiting
Laguna Hills, California, United States, 92653
Contact: James Kurtzman, MD     949-452-7199     jtk@stanfordalumni.org    
Principal Investigator: James Kurtzman, MD            
United States, Colorado
Swedish Medical Center Recruiting
Denver, Colorado, United States, 80110
Contact: Kent Heyborne, MD     303-860-9990     kent_heyborne@pediatrix.com    
Principal Investigator: Kent Heyborne, MD            
Presbyterian/St Luke's Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Richard Porreco, MD     303-860-9990     richard_porreco@pediatrix.com    
Principal Investigator: Richard Porreco, MD            
United States, Georgia
DeKalb Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Bobbie Boyd, RN     770-279-3838     Bobbie_boyd@pediatrix.com    
Principal Investigator: Paul Browne, MD            
Southern Regional Medical Center Recruiting
Riverdale, Georgia, United States, 30274
Contact: Bobbie Boyd, RN     770-279-3838     bobbie_boyd@pediatrix.com    
Principal Investigator: Paul Browne, MD            
United States, Texas
Harris Methodist Fort Worth Hospital Active, not recruiting
Fort Worth, Texas, United States, 76104
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122-4307
Contact: David Luthy, MD     206-386-2101     david_luthy@pediatrix.com    
Principal Investigator: David Luthy, MD            
Sub-Investigator: David Gorenberg, MD            
Sponsors and Collaborators
Obstetrix Medical Group
Investigators
Principal Investigator: Karrie Francois, MD Pediatrix-Obstetrix Medical Group, Inc.
  More Information

The Clinical Protocols home page on the sponsor's Web site. Click the Tandem Mass Protocol for more information about this study.  This link exits the ClinicalTrials.gov site

Responsible Party: Pediatrix Medical Group ( Kimberly Maurel )
Study ID Numbers: OBX 0005.3, Tandem MS - 0005.3
Study First Received: August 31, 2005
Last Updated: March 12, 2008
ClinicalTrials.gov Identifier: NCT00143039  
Health Authority: United States: Institutional Review Board

Keywords provided by Obstetrix Medical Group:
NIH
Severe Symmetrical IUGR
Tandem Mass Spectrometry
Nonimmune Hydrops
Severe Symmetrical Intrauterine Growth Restriction

Study placed in the following topic categories:
Erythroblastosis, Fetal
Pregnancy Complications
Hematologic Diseases
Hydrops fetalis
Edema
Thalassemia
Alpha-Thalassemia
Signs and Symptoms
Fetal Diseases
Fetal edema
Genetic Diseases, Inborn
Hydrops Fetalis
Hemoglobinopathies
Growth Disorders
Hemoglobinopathy
Fetal Growth Retardation

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases
Blood Group Incompatibility

ClinicalTrials.gov processed this record on January 16, 2009