Clinical trial NCT00143039: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hydrops Fetalis
Fetal Growth Retardation
Keywords: NIH
Severe Symmetrical IUGR
Tandem Mass Spectrometry
Nonimmune Hydrops
Severe Symmetrical Intrauterine Growth Restriction
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: 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.
timeFrame: comparrison down with in 2 days of life.
Secondary outcomes:
measure: Incidence of Neonatal Complications
timeFrame: during the neonatal period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Sammaritan Hospital
state: Arizona
city: Phoenix
country: United States
facility: Banner Desert Samaritan Hospital
state: Arizona
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Denver
country: United States
facility: Swedish Medical Center
state: Colorado
city: Denver
country: United States
facility: Presbyterian/St Luke's Hospital
state: Colorado
city: Decatur
country: United States
facility: DeKalb Medical Center
state: Georgia
city: Riverdale
country: United States
facility: Southern Regional Medical Center
state: Georgia
city: Fort Worth
country: United States
facility: Harris Methodist Fort Worth Hospital
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Pediatrix-Obstetrix Medical Group, Inc.
name: Karrie Francois, MD
role: PRINCIPAL_INVESTIGATOR
References: