Hydrops FetalisTandemMSNCT00143039
Amniotic Fluid Tandem Mass Spectrometry for Pregnancies Complicated by NIH and Severe Symmetrical IUGR
An observational study of Hydrops Fetalis and Fetal Growth Retardation, run by Obstetrix Medical Group at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Hydrops Fetalis, Fetal Growth Retardation
- What is being tested?
- Tandem MS test for inborn errors of metabolism
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2006to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
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.
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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
DeKalb Medical Center
Decatur, Georgia, 30033
Swedish Medical Center
Denver, Colorado, 80110
Presbyterian/St Luke's Hospital
Denver, Colorado, 80218
Harris Methodist Fort Worth Hospital
Fort Worth, Texas, 76104
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Long Beach Memorial Medical Center
Long Beach, California, 90801-1428
Banner Good Sammaritan Hospital
Phoenix, Arizona, 85006
Banner Desert Samaritan Hospital
Phoenix, Arizona, 85202
Southern Regional Medical Center
Riverdale, Georgia, 30274
Good Samaritan Hospital
San Jose, California, 95124
Swedish Medical Center
Seattle, Washington, 98122-4307
About this study
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
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.
Read the 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.
- Conditions
- Hydrops Fetalis, Fetal Growth Retardation
- Being tested
- Tandem MS test for inborn errors of metabolism
- Keywords
- NIH, Severe Symmetrical IUGR, Tandem Mass Spectrometry, Nonimmune Hydrops, Severe Symmetrical Intrauterine Growth Restriction
- Medical subject headings
- Hydrops Fetalis, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem MS test for inborn errors of metabolismProcedure or surgery
Also called Tandem MS
Tandem MS spectrometry test will be done on all maternal blood, amniotic fluid and newborn blood samples for both groups.
| Study group | Role | What they receive |
|---|---|---|
| NIH/SSIUGR fetuses | Group 1 includes pregnancies complicated by a fetus with either Non-Immune Hydrops or Severe Symmetrical IUGR. Receives: 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. Receives: Procedure: Tandem MS test for inborn errors of metabolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: comparrison down with in 2 days of life.
Secondary outcomes (1)
Incidence of Neonatal Complications
Will include neonatal complications in pregnancies complicated by NIH and severe symmetrical IUGR.
Measured: during the neonatal period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startMar 2006
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: No metabolic disordered ID'd by TMS in either control/test group at \>50%enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrops FetalisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obstetrix Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karrie Francois, MD, Principal investigator, Pediatrix-Obstetrix Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143039
- Sponsor's protocol ID
- OBX 0005.3
- Other IDs
- Tandem MS - 0005.3
- Acronym
- TandemMS
- Status last verified
- Dec 2014
- First submitted
- 31 Aug 2005
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00143039
- Acronym / sponsor ID
- TandemMS / OBX 0005.3
- Conditions
- Hydrops Fetalis, Fetal Growth Retardation
- Keywords
- NIH, Severe Symmetrical IUGR, Tandem Mass Spectrometry, Nonimmune Hydrops, Severe Symmetrical Intrauterine Growth Restriction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No metabolic disordered ID'd by TMS in either control/test group at \>50%enrolled
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Obstetrix Medical GroupIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIH/SSIUGR fetuses | – | Procedure: Tandem MS test for inborn errors of metabolismGroup 1 includes pregnancies complicated by a fetus with either Non-Immune Hydrops or Severe Symmetrical IUGR. |
| Control-Normal fetus | – | Procedure: Tandem MS test for inborn errors of metabolismGroup 2 includes all normally appearing fetuses on U/S who will be having a diagnostic amniocentesis as part of their routine care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tandem MS test for inborn errors of metabolismAlso: Tandem MSTandem MS spectrometry test will be done on all maternal blood, amniotic fluid and newborn blood samples for both groups. | Procedure or surgery | Control-Normal fetus, NIH/SSIUGR fetuses |
Primary outcome
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.
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.
1 secondary outcome
Incidence of Neonatal Complications
Time frame: during the neonatal period
Results and safety
The study was stopped early (reason given: No metabolic disordered ID'd by TMS in either control/test group at \>50%enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
Related trials for Hydrops Fetalis
Active, not recruiting
Hydrops: Diagnosing & Redefining Outcomes With Precision Study
Hydrops Fetalis, Birth Defect
Enrolling by invitation
Uncovering the Etiologies of Non-immune Hydrops Fetalis
Non-Immune Hydrops Fetalis
RecruitingObservational study
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
High Risk Pregnancy, Congenital Heart Disease
Recruiting
In-utero Hematopoietic Stem Cell Transplantation for the Treatment of Fetuses With Bart's Hydrops Fetalis Syndrome
Haemoglobin Barts Hydrops
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karrie Francois, MD principal investigator
Pediatrix-Obstetrix Medical Group, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrops Fetalis and Fetal Growth Retardation, run by Obstetrix Medical Group at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No metabolic disordered ID'd by TMS in either control/test group at \>50%enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.