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

NCT ID: NCT00143039

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Hydrops Fetalis Fetal Growth Retardation

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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NIH/SSIUGR fetuses

Group 1 includes pregnancies complicated by a fetus with either Non-Immune Hydrops or Severe Symmetrical IUGR.

Tandem MS test for inborn errors of metabolism

Intervention Type PROCEDURE

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

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.

Tandem MS test for inborn errors of metabolism

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Tandem MS

Eligibility Criteria

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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


* 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

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


* Asymmetrical IUGR
* Structural anomaly identified by ultrasound
* Chromosomal aneuploidy
* Multiple gestations
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Obstetrix Medical Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karrie Francois, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatrix-Obstetrix Medical Group, Inc.

Locations

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Banner Good Sammaritan Hospital

Phoenix, Arizona, United States

Site Status

Banner Desert Samaritan Hospital

Phoenix, Arizona, United States

Site Status

Saddleback Memorial Medical Center

Laguna Hills, California, United States

Site Status

Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status

Good Samaritan Hospital

San Jose, California, United States

Site Status

Swedish Medical Center

Denver, Colorado, United States

Site Status

Presbyterian/St Luke's Hospital

Denver, Colorado, United States

Site Status

DeKalb Medical Center

Decatur, Georgia, United States

Site Status

Southern Regional Medical Center

Riverdale, Georgia, United States

Site Status

Harris Methodist Fort Worth Hospital

Fort Worth, Texas, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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Tandem MS - 0005.3

Identifier Type: -

Identifier Source: secondary_id

OBX 0005.3

Identifier Type: -

Identifier Source: org_study_id