Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006445
Status:
UNKNOWN
Last Update Posted:
2007-02-22
First Post:
2000-11-04
Brief Title:
Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
First and 2nd Trimester Evaluation of the Risk of Aneuploidy
Status:
UNKNOWN
Status Verified Date:
2003-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Too much or too little genetic information chromosome material can cause abnormal development of the fetus or death Each year approximately 25 million pregnant women are screened for Down Syndrome using invasive screening methods amniocentesis or chorionic villus sampling This 11 center study of 38000 women will compare the accuracy of the several non-invasive tests in the first and second trimesters of pregnancy versus amniocentesis or diagnosis at birth to diagnose aneuploidy or Down Syndrome
Detailed Description:
The FASTER First and Second Trimester Evaluation of Risk Trial is a multicenter prospective study comparing the accuracy of first and second trimester non-invasive screening methods for Down syndrome and other aneuploidies to diagnosis at delivery or miscarriagefetal loss All women will receive the two non-invasive test batteries in both the first and second trimesters The accuracy of the results of different combinations of non-invasive tests will be compared with diagnosis at delivery or at miscarriage or later fetal loss
First trimester screening will involve ultrasound measurement of fetal nuchal translucency NT thickness at 10-14 weeks gestation together with maternal age and serum levels of pregnancy associated plasma protein-A PPAP-A and free-beta human chorionic gonadotropin FbhCG Second trimester screening will be based on the current standard of care serum triple screen which consists of alpha fetoprotein AFP unconjugated estriol uE3 and hCG performed at 15-18 weeks gestation together with maternal age and the new serum marker inhibin-A If patients screen positive risk 1 in 380 the patients are notified and offered invasive testing at 15 weeks a serum quad test an additional tube of blood for analysis of the presence of fetal nucleated erythrocytes in maternal blood NIFTY National Institute of Child Health and Human Development Fetal Cell Study and amniocentesis on those who accept True positive cases receive counseling True negative cases those who decline invasive testing and those who screen negative after the serum quad test receive routine care with final pediatric outcome Patients with an a priori risk for Down Syndrome may elect to have invasive fetal testing at 15 weeks after quad testing For all fetuses with a NT measurement greater than 3 mm and where karyotype is found to be normal after amniocentesis will be followed with a repeat ultrasound examination at 18 to 20 weeks gestation to evaluate fetal anatomy particularly fetal cardiac structure Final pediatric examination information will be obtained following delivery If pregnancy results in miscarriage or later fetal loss attempts will be made to karyotype any fetal tissue This is especially important for those pregnancies that abort spontaneously between the time of the first and second trimester methods of screening Pregnancy outcome data will be obtained in all cases
First trimester screening will involve ultrasound measurement of fetal nuchal translucency NT thickness at 10-14 weeks gestation together with maternal age and serum levels of pregnancy associated plasma protein-A PPAP-A and free-beta human chorionic gonadotropin FbhCG Second trimester screening will be based on the current standard of care serum triple screen which consists of alpha fetoprotein AFP unconjugated estriol uE3 and hCG performed at 15-18 weeks gestation together with maternal age and the new serum marker inhibin-A If patients screen positive risk 1 in 380 the patients are notified and offered invasive testing at 15 weeks a serum quad test an additional tube of blood for analysis of the presence of fetal nucleated erythrocytes in maternal blood NIFTY National Institute of Child Health and Human Development Fetal Cell Study and amniocentesis on those who accept True positive cases receive counseling True negative cases those who decline invasive testing and those who screen negative after the serum quad test receive routine care with final pediatric outcome Patients with an a priori risk for Down Syndrome may elect to have invasive fetal testing at 15 weeks after quad testing For all fetuses with a NT measurement greater than 3 mm and where karyotype is found to be normal after amniocentesis will be followed with a repeat ultrasound examination at 18 to 20 weeks gestation to evaluate fetal anatomy particularly fetal cardiac structure Final pediatric examination information will be obtained following delivery If pregnancy results in miscarriage or later fetal loss attempts will be made to karyotype any fetal tissue This is especially important for those pregnancies that abort spontaneously between the time of the first and second trimester methods of screening Pregnancy outcome data will be obtained in all cases
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 |
|---|---|---|---|
| 1 RO1 HD37523 | None | None | None |