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Sponsored by: |
Obstetrix Medical Group |
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Information provided by: | Obstetrix Medical Group |
ClinicalTrials.gov Identifier: | NCT00143039 |
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.
Condition | Intervention | Phase |
---|---|---|
Hydrops Fetalis Fetal Growth Retardation |
Procedure: Tandem MS test for inborn errors of metabolism |
Phase I |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
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 |
Estimated Enrollment: | 82 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | October 2008 |
Groups/Cohorts | Assigned Interventions |
---|---|
NIH/SSIUGR fetuses
Group 1 includes pregnancies complicated by a fetus with either Non-Immune Hydrops or Severe Symmetrical IUGR.
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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.
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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.
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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.
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
NIH Inclusion Criteria:
NIH Exclusion Criteria:
IUGR Inclusion Criteria:
IUGR Exclusion Criteria:
Contact: Kimberly A Maurel, RN, MSN, CNS | 714-593-9171 | kimberly_maurel@pediatrix.com |
Contact: Diana Abril, RN, BSN | 480-65--8644 | diana_abril@pediatrix.com |
United States, Arizona | |
Banner Good Sammaritan Hospital | Recruiting |
Phoenix, Arizona, United States, 85006 | |
Contact: Karrie Francois, MD 480-969-5999 ext 201 karrie_Francois@pediatrix.com | |
Contact: Melissa Ingersoll, RN | |
Principal Investigator: Karrie Francois, MD | |
Banner Desert Samaritan Hospital | Recruiting |
Phoenix, Arizona, United States, 85202 | |
Contact: Melissa Ingersoll, RN 602-239-3632 melissa_ingersoll@pediatrix.com | |
Principal Investigator: Karrie Francious, MD | |
United States, California | |
Good Samaritan Hospital | Recruiting |
San Jose, California, United States, 95124 | |
Contact: Andrew Combs, MD 408-371-7111 andrew_combs@pediatrix.com | |
Principal Investigator: Andrew Combs, MD | |
Long Beach Memorial Medical Center | Recruiting |
Long Beach, California, United States, 90801-1428 | |
Contact: Katherine Berkowitz, MD 562-933-2730 katherine_berkowitz@pediatrix.com | |
Principal Investigator: Katherine Berkowitz, MD | |
Saddleback Memorial Medical Center | Not yet recruiting |
Laguna Hills, California, United States, 92653 | |
Contact: James Kurtzman, MD 949-452-7199 jtk@stanfordalumni.org | |
Principal Investigator: James Kurtzman, MD | |
United States, Colorado | |
Swedish Medical Center | Recruiting |
Denver, Colorado, United States, 80110 | |
Contact: Kent Heyborne, MD 303-860-9990 kent_heyborne@pediatrix.com | |
Principal Investigator: Kent Heyborne, MD | |
Presbyterian/St Luke's Hospital | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Richard Porreco, MD 303-860-9990 richard_porreco@pediatrix.com | |
Principal Investigator: Richard Porreco, MD | |
United States, Georgia | |
DeKalb Medical Center | Recruiting |
Decatur, Georgia, United States, 30033 | |
Contact: Bobbie Boyd, RN 770-279-3838 Bobbie_boyd@pediatrix.com | |
Principal Investigator: Paul Browne, MD | |
Southern Regional Medical Center | Recruiting |
Riverdale, Georgia, United States, 30274 | |
Contact: Bobbie Boyd, RN 770-279-3838 bobbie_boyd@pediatrix.com | |
Principal Investigator: Paul Browne, MD | |
United States, Texas | |
Harris Methodist Fort Worth Hospital | Active, not recruiting |
Fort Worth, Texas, United States, 76104 | |
United States, Washington | |
Swedish Medical Center | Recruiting |
Seattle, Washington, United States, 98122-4307 | |
Contact: David Luthy, MD 206-386-2101 david_luthy@pediatrix.com | |
Principal Investigator: David Luthy, MD | |
Sub-Investigator: David Gorenberg, MD |
Principal Investigator: | Karrie Francois, MD | Pediatrix-Obstetrix Medical Group, Inc. |
Responsible Party: | Pediatrix Medical Group ( Kimberly Maurel ) |
Study ID Numbers: | OBX 0005.3, Tandem MS - 0005.3 |
Study First Received: | August 31, 2005 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00143039 |
Health Authority: | United States: Institutional Review Board |
NIH Severe Symmetrical IUGR Tandem Mass Spectrometry Nonimmune Hydrops Severe Symmetrical Intrauterine Growth Restriction |
Erythroblastosis, Fetal Pregnancy Complications Hematologic Diseases Hydrops fetalis Edema Thalassemia Alpha-Thalassemia Signs and Symptoms |
Fetal Diseases Fetal edema Genetic Diseases, Inborn Hydrops Fetalis Hemoglobinopathies Growth Disorders Hemoglobinopathy Fetal Growth Retardation |
Pathologic Processes Immune System Diseases Blood Group Incompatibility |