Because SLE flares are often accompanied by alterations in serum complement levels and lupus flares often occur in pregnancy, a four-group study is necessary to distinguish between the contributions of each condition to poor pregnancy outcome and to characterize the specific markers that predict poor pregnancy outcome in each condition.:
Group 1: Patients with aPL antibodies (defined below) and less than 4 criteria for the American College of Rheumatology (ACR) classification of SLE (8).
Group 2: Patients with at least 4 ACR criteria for SLE and the presence of aPL antibodies.
Group 3: Patients with at least 4 ACR criteria for SLE without aPL antibodies.
Group 4: Healthy controls.
At least one of the following aPL criteria* must be present at screening or within 2 visits post-screening in assays run at core lab:
• aCL: IgG ≥ 40 GPL units; IgM ≥ 40 MPL units
• Positive LAC: RVVT, Kaolin, dilute TTI, PTT LA
• Anti-β2GPI: IgG ≥ 40 GPL units; IgM ≥ 40 MPL units
At least one of the following must be present:
• History of positive aPL pre-pregnancy at local or core lab [History of Moderate/High aCL (IgG > 25 GPL units; IgM > 25 MPL units), History of positive LAC (RVVT, Kaolin, dilute TTI, PTT LA, History of Moderate/High anti-β2GPI (IgG > 25 GPL units; IgM > 25 MPL units)], between six weeks and five years prior to the screening visit.
• A second positive aPL during pregnancy (at core lab, meeting the above aPL criteria*)
• A second positive aPL at 3MPP (at core lab, meeting the above aPL criteria*)
Inclusion Criteria for Groups all groups:
1. Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated β-HCG, but <12 weeks by gestation (for groups 3 and 4) and <18 weeks by gestation (for groups 1 and 2)
2. Age 18-45 years and able to give informed consent
3. Hct > 26%
Inclusion Criteria for Group 4:
1. At least one successful pregnancy
2. No history of fetal death (death of conceptus > 10 weeks’ gestation)
3. No more than 1 miscarriage < 10 weeks’ gestation
4. No history of positive aPL in local lab or positive aPL in core labs at screening
5. Not currently a smoker
6. No medical problems requiring chronic treatment
Inclusion Criteria for Groups 2B and 3B:
(One or more of the following must be present):
1.Prednisone >20 mg/day
2.Renal disease: Proteinuria [urine protein > 1000 mg in 24 hours or protein/creatinine ratio >1000 mg protein/gram creatinine on spot urine (either test performed if dipstick >1+)]; RBC casts; serum creatinine >1.2 mg/dl
3.Hypertension (blood pressure >140/90 mmHg)