Amniotic Fluid Tandem Mass Spectrometry for Pregnancies Complicated by NIH and Severe Symmetrical IUGR (TandemMS)

This study has been terminated.
(No metabolic disordered ID'd by TMS in either control/test group at >50%enrolled)
Sponsor:
Information provided by (Responsible Party):
Obstetrix Medical Group
ClinicalTrials.gov Identifier:
NCT00143039
First received: August 31, 2005
Last updated: March 15, 2012
Last verified: March 2012
  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 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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

Resource links provided by NLM:


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 ]
    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.


Secondary Outcome Measures:
  • Incidence of Neonatal Complications [ Time Frame: during the neonatal period ] [ Designated as safety issue: No ]
    Will include neonatal complications in pregnancies complicated by NIH and severe symmetrical IUGR.


Enrollment: 48
Study Start Date: March 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.
Other Name: Tandem MS
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.
Other Name: Tandem MS

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143039

Locations
United States, Arizona
Banner Desert Samaritan Hospital
Phoenix, Arizona, United States, 85202
Banner Good Sammaritan Hospital
Phoenix, Arizona, United States, 85006
United States, California
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
Long Beach Memorial Medical Center
Long Beach, California, United States, 90801-1428
Good Samaritan Hospital
San Jose, California, United States, 95124
United States, Colorado
Swedish Medical Center
Denver, Colorado, United States, 80110
Presbyterian/St Luke's Hospital
Denver, Colorado, United States, 80218
United States, Georgia
DeKalb Medical Center
Decatur, Georgia, United States, 30033
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274
United States, Texas
Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States, 76104
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122-4307
Sponsors and Collaborators
Obstetrix Medical Group
Investigators
Principal Investigator: Karrie Francois, MD Pediatrix-Obstetrix Medical Group, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT00143039     History of Changes
Other Study ID Numbers: OBX 0005.3, Tandem MS - 0005.3
Study First Received: August 31, 2005
Last Updated: March 15, 2012
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

Additional relevant MeSH terms:
Edema
Fetal Growth Retardation
Hydrops Fetalis
Alpha-Thalassemia
Blood Group Incompatibility
Erythroblastosis, Fetal
Fetal Diseases
Genetic Diseases, Inborn
Growth Disorders
Hematologic Diseases
Hemoglobinopathies
Immune System Diseases
Pathologic Processes
Pregnancy Complications
Signs and Symptoms
Thalassemia

ClinicalTrials.gov processed this record on October 23, 2014