The objective of this pilot study is to prospectively evaluate amniotic fluid of pregnancies complicated by NonImmune Hydrops and severe symmetrical Intrauterine Growth Restriction by tandem mass spectrometry for inborn errors of metabolism.

Condition	Intervention	Phase
* Nonimmune Hydrops * Severe Symmetrical Intrauterine Growth Restriction	Procedure: Tandem Mass Spectrometry test for inborn errors of metabolism	Phase I

Further Study Details: 

Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  81

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 (1-3). Both of these conditions have high perinatal and neonatal mortality rates (4-7). 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 (8,9). 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 (3,8). 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.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Female

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00143039

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

Arizona
      Banner Good Sammaritan Hospital, Phoenix,  Arizona,  85006,  United States
California
      Good Samaritan Hospital, San Jose,  California,  95124,  United States
      Long Beach Memorial Medical Center, Long Beach,  California,  90801-1428,  United States
      Saddleback Memorial Medical Center, Laguna Hills,  California,  92653,  United States
Colorado
      Swedish Medical Center, Denver,  Colorado,  80110,  United States
      Presbyterian/St Luke’s Hospital, Denver,  Colorado,  80218,  United States
Texas
      Harris Methodist Fort Worth Hospital, Fort Worth,  Texas,  76104,  United States
Washington
      Swedish Medical Center, Seattle,  Washington,  98122-4307,  United States

Study chairs or principal investigators

Karrie Francois, MD,  Principal Investigator,  Pediatrix-Obstetrix Medical Group, Inc.   

Study ID Numbers:  OBX0005
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00143039
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06