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

NCT00143039 | Terminated DMC

• 2 other identifiers: OBX 0005.3Tandem MS - 0005.3
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 11

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.

Conditions

Hydrops Fetalis; Fetal Growth Retardation

Keywords

NIH; Severe Symmetrical IUGR; Tandem Mass Spectrometry; Nonimmune Hydrops; Severe Symmetrical Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Incidence of Neonatal Complications

  during the neonatal period

Study Arms (2)

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

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

Interventions

Tandem MS test for inborn errors of metabolism PROCEDURE

Tandem MS spectrometry test will be done on all maternal blood, amniotic fluid and newborn blood samples for both groups.

Also known as: Tandem MS

Control-Normal fetus; NIH/SSIUGR fetuses

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Singleton gestation
• 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

You may not qualify if:

• 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
• Singleton gestation
• 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
• Asymmetrical IUGR
• Structural anomaly identified by ultrasound
• Chromosomal aneuploidy
• Multiple gestations

Sponsors & Collaborators

• Obstetrix Medical Group: lead

Study Sites (11)

Banner Good Sammaritan Hospital

Phoenix, Arizona, 85006, United States

Location

Banner Desert Samaritan Hospital

Phoenix, Arizona, 85202, United States

Location

Saddleback Memorial Medical Center

Laguna Hills, California, 92653, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90801-1428, United States

Location

Good Samaritan Hospital

San Jose, California, 95124, United States

Location

Swedish Medical Center

Denver, Colorado, 80110, United States

Location

Presbyterian/St Luke's Hospital

Denver, Colorado, 80218, United States

Location

DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, 30274, United States

Location

Harris Methodist Fort Worth Hospital

Fort Worth, Texas, 76104, United States

Location

Swedish Medical Center

Seattle, Washington, 98122-4307, United States

Location

MeSH Terms

Conditions

Hydrops Fetalis; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Erythroblastosis, Fetal; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; alpha-Thalassemia; Thalassemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Immune System Diseases; Edema; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Growth Disorders; Pathologic Processes

Study Officials

• Karrie Francois, MD

  Pediatrix-Obstetrix Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: March 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (11)