Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00143039
Status:
TERMINATED
Last Update Posted:
2014-12-19
First Post:
2005-08-31
Brief Title:
Amniotic Fluid Tandem Mass Spectrometry for Pregnancies Complicated by NIH and Severe Symmetrical IUGR
Sponsor:
Obstetrix Medical Group
Organization:
Pediatrix
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No metabolic disordered IDd by TMS in either controltest group at 50enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TandemMS
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Tandem MS - 00053 | None | None | None |