Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004663
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-07
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:
None
Brief Summary:
OBJECTIVES I Evaluate whether pregnancy is an independent risk factor that affects disease activity in women with systemic lupus erythematosus
II Evaluate whether maternal disease activity is a risk factor for adverse pregnancy outcome
II Evaluate whether maternal disease activity is a risk factor for adverse pregnancy outcome
Detailed Description:
PROTOCOL OUTLINE This is a case-controlled study Intensive data collection begins when a patient becomes pregnant
Pregnant women are evaluated with interval pregnancyexposure history and a clinical exam including the Systemic Lupus Activity Measure SLAM Assessments are scheduled every 3 months as follows visit 1 when the pregnancy is confirmed visit 2 during the second trimester visit 3 during the third trimester visit 4 at 3 months postpartum and visit 5 at 6 months postpartum Visits 4 and 5 include an infant exam for growth and morphologic parameters these visits occur on the same schedule if there is a miscarriage or stillbirth
Patients not currently pregnant are randomly chosen to be followed as controls These patients undergo a review of current pregnancy status and measures of disease activity including SLAM every 3 months for 5 visits
Pregnant women are evaluated with interval pregnancyexposure history and a clinical exam including the Systemic Lupus Activity Measure SLAM Assessments are scheduled every 3 months as follows visit 1 when the pregnancy is confirmed visit 2 during the second trimester visit 3 during the third trimester visit 4 at 3 months postpartum and visit 5 at 6 months postpartum Visits 4 and 5 include an infant exam for growth and morphologic parameters these visits occur on the same schedule if there is a miscarriage or stillbirth
Patients not currently pregnant are randomly chosen to be followed as controls These patients undergo a review of current pregnancy status and measures of disease activity including SLAM every 3 months for 5 visits
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-501 | None | None | None |