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

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ClinicalTrials.gov Identifier: NCT00143039
Recruitment Status : Terminated (No metabolic disordered ID'd by TMS in either control/test group at >50%enrolled)
First Posted : September 2, 2005
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Pediatrix ( Obstetrix Medical Group )

Tracking Information
First Submitted Date August 31, 2005
First Posted Date September 2, 2005
Last Update Posted Date December 19, 2014
Study Start Date March 2006
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2012)		 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. ]
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.
Original Primary Outcome Measures
 (submitted: September 1, 2005)		 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.
Change History
Current Secondary Outcome Measures
 (submitted: March 15, 2012)		 Incidence of Neonatal Complications [ Time Frame: during the neonatal period ]
Will include neonatal complications in pregnancies complicated by NIH and severe symmetrical IUGR.
Original Secondary Outcome Measures
 (submitted: September 1, 2005)		 Will include obstetrical complications and neonatal outcomes of pregnancies complicated by NIH and severe symmetrical IUGR. Review of the medical records and neonatal RDS database queries will be used to evaluate these varia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Amniotic Fluid Tandem Mass Spectrometry for Pregnancies Complicated by NIH and Severe Symmetrical IUGR
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
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 spectrometry for inborn errors of metabolism.
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Hydrops Fetalis
  • Fetal Growth Retardation
Intervention 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
Study Groups/Cohorts
  • NIH/SSIUGR fetuses
    Group 1 includes pregnancies complicated by a fetus with either Non-Immune Hydrops or Severe Symmetrical IUGR.
    Intervention: Procedure: Tandem MS test for inborn errors of metabolism
  • 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.
    Intervention: Procedure: Tandem MS test for inborn errors of metabolism
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: August 20, 2009)		 48
Original Enrollment
 (submitted: September 1, 2005)		 81
Actual Study Completion Date August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00143039
Other Study ID Numbers OBX 0005.3
Tandem MS - 0005.3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Pediatrix ( Obstetrix Medical Group )
Original Responsible Party Not Provided
Current Study Sponsor Obstetrix Medical Group
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Karrie Francois, MD Pediatrix-Obstetrix Medical Group, Inc.
PRS Account Pediatrix
Verification Date December 2014