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

Fetal Growth Retardation Clinical Trial

— TandemMS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00143039
• Other study ID #: OBX 0005.3
• Secondary ID: Tandem MS - 0005
• Status: Terminated
• Phase: Phase 1
• First received: August 31, 2005
• Last updated: December 17, 2014
• Start date: March 2006
• Est. completion date: August 2009

Study information

• Verified date: December 2014
• Source: Mednax Center for Research, Education and Quality
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Edema
• Fetal Growth Retardation
• Hydrops Fetalis

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.

Locations

Country	Name	City	State
United States	DeKalb Medical Center	Decatur	Georgia
United States	Presbyterian/St Luke's Hospital	Denver	Colorado
United States	Swedish Medical Center	Denver	Colorado
United States	Harris Methodist Fort Worth Hospital	Fort Worth	Texas
United States	Saddleback Memorial Medical Center	Laguna Hills	California
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Banner Desert Samaritan Hospital	Phoenix	Arizona
United States	Banner Good Sammaritan Hospital	Phoenix	Arizona
United States	Southern Regional Medical Center	Riverdale	Georgia
United States	Good Samaritan Hospital	San Jose	California
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Obstetrix Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	comparrison down with in 2 days of life.	No
Secondary	Incidence of Neonatal Complications	Will include neonatal complications in pregnancies complicated by NIH and severe symmetrical IUGR.	during the neonatal period	No

External Links

•   The Clinical Protocols home page on the sponsor's Web site. Click the Tandem Mass Protocol for more information about this study.