Amniotic Fluid Tandem Mass Spectrometry for Pregnancies Complicated by NIH and Severe Symmetrical IUGR (TandemMS)
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Purpose
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 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: 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 |
- 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. [ Time Frame: comparrison down with in 2 days of life. ] [ Designated as safety issue: No ]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.
- Incidence of Neonatal Complications [ Time Frame: during the neonatal period ] [ Designated as safety issue: No ]Will include neonatal complications in pregnancies complicated by NIH and severe symmetrical IUGR.
| Enrollment: | 48 |
| Study Start Date: | March 2006 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
Tandem MS spectrometry test will be done on all maternal blood, amniotic fluid and newborn blood samples for both groups.
Other Name: Tandem MS
|
|
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
Tandem MS spectrometry test will be done on all maternal blood, amniotic fluid and newborn blood samples for both groups.
Other Name: Tandem MS
|
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| 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:
- 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
Contacts and Locations| United States, Arizona | |
| Banner Good Sammaritan Hospital | |
| Phoenix, Arizona, United States, 85006 | |
| Banner Desert Samaritan Hospital | |
| Phoenix, Arizona, United States, 85202 | |
| United States, California | |
| Saddleback Memorial Medical Center | |
| Laguna Hills, California, United States, 92653 | |
| Long Beach Memorial Medical Center | |
| Long Beach, California, United States, 90801-1428 | |
| Good Samaritan Hospital | |
| San Jose, California, United States, 95124 | |
| United States, Colorado | |
| Swedish Medical Center | |
| Denver, Colorado, United States, 80110 | |
| Presbyterian/St Luke's Hospital | |
| Denver, Colorado, United States, 80218 | |
| United States, Georgia | |
| DeKalb Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| Southern Regional Medical Center | |
| Riverdale, Georgia, United States, 30274 | |
| United States, Texas | |
| Harris Methodist Fort Worth Hospital | |
| Fort Worth, Texas, United States, 76104 | |
| United States, Washington | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98122-4307 | |
| Principal Investigator: | Karrie Francois, MD | Pediatrix-Obstetrix Medical Group, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Obstetrix Medical Group |
| ClinicalTrials.gov Identifier: | NCT00143039 History of Changes |
| Other Study ID Numbers: | OBX 0005.3, Tandem MS - 0005.3 |
| Study First Received: | August 31, 2005 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Obstetrix Medical Group:
|
NIH Severe Symmetrical IUGR Tandem Mass Spectrometry Nonimmune Hydrops Severe Symmetrical Intrauterine Growth Restriction |
Additional relevant MeSH terms:
|
Alpha-Thalassemia Edema Fetal Growth Retardation Hydrops Fetalis Pregnancy Complications Signs and Symptoms Fetal Diseases Growth Disorders |
Pathologic Processes Erythroblastosis, Fetal Blood Group Incompatibility Hematologic Diseases Thalassemia Hemoglobinopathies Genetic Diseases, Inborn Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013