Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513591
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2007-08-06
Brief Title:
Duke Autoimmunity in Pregnancy Registry
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Duke Autoimmunity in Pregnancy Registry
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
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:
DAP Registry
Brief Summary:
It is difficult to predict how a women with an autoimmune disease will do during pregnancy Some women will improve others will worsen Some pregnancies progress normally and others become very complicated
The Duke Autoimmunity in Pregnancy DAP Registry will enroll women with autoimmune diseases such as lupus rheumatoid arthritis scleroderma and Sjogrens syndrome who wish to become or already are pregnant We will follow these women throughout pregnancy to better understand how their autoimmune disease affects their pregnancy and vice versa
The Duke Autoimmunity in Pregnancy DAP Registry will enroll women with autoimmune diseases such as lupus rheumatoid arthritis scleroderma and Sjogrens syndrome who wish to become or already are pregnant We will follow these women throughout pregnancy to better understand how their autoimmune disease affects their pregnancy and vice versa
Detailed Description:
Women with a systemic autoimmune disease that would be followed by a rheumatologist will be included in this study
All women will be seen every 4-6 weeks throughout pregnancy At each visit women will complete a questionnaire the physician will determine the current level of disease activity and a blood sample will be taken For women with lupus and healthy women and additional visit will occur at the start of the 3rd trimester for a closer evaluation of predictors of preterm birth
This is not an intervention study Women will not be given experimental medication All recommendations for treatment and monitoring will be made based on the best available data with input from the treating obstetrician
Women in this Registry are not required to be seen by Duke Obstetrics nor to deliver at a Duke Hospital
All women will be seen every 4-6 weeks throughout pregnancy At each visit women will complete a questionnaire the physician will determine the current level of disease activity and a blood sample will be taken For women with lupus and healthy women and additional visit will occur at the start of the 3rd trimester for a closer evaluation of predictors of preterm birth
This is not an intervention study Women will not be given experimental medication All recommendations for treatment and monitoring will be made based on the best available data with input from the treating obstetrician
Women in this Registry are not required to be seen by Duke Obstetrics nor to deliver at a Duke Hospital
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