The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers. The purpose of the study is 1) to determine whether certain proteins (called complement split products) that can injure healthy organs can be used to predict poor pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid syndrome (APS), and/or 2) to determine whether elevated levels of circulating antiangiogenic factors predict pregnancy complications in patients with aPL antibodies and/or SLE.
Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated β-HCG, but ≤ 12 weeks by gestation (for subjects without aPL antibodies) and ≤18 weeks (for subjects with aPL antibodies)
Patient between the ages of 18-45 and able to give informed consent, or age < 18 years with parental consent
Hematocrit > 26%
aCL: IgG >= 40 GPL units; IgM >= 40 MPL units
Diabetes mellitus (Type I and Type II) antedating pregnancy
Known or suspected hereditary complement deficiency (defined by CH50 = 0)
Pregnant patients identified by investigators at each study site
Case-control
Prospective
Not listed
Otherwise unexplained fetal death occurring after 12 weeks gestation
Fetal death occurring after 12 weeks' gestation and not explained by chromosomal abnormalities, anatomic malformations, or congenital infections.
Neonatal death
Neonatal death prior to hospital discharge and due to complications of prematurity
Preterm delivery prior to 36 weeks' gestation
Indicated preterm delivery prior to 36 weeks' gestation because of gestational hypertension, preeclampsia-eclampsia or placental insufficiency
Small for gestational age (SGA) <5th %ile
Small for gestational age (SGA) \<5th %ile in the absence of anatomical or chromosomal abnormalities and/or delivery before 36 weeks because of intrauterine growth restriction (IUGR).
Gestational age
Gestational age (weeks and days) at the end of pregnancy
Birth weight
Birth weight
Number of days neonate requires positive pressure ventilation
Number of days neonate requires positive pressure ventilation
Total number of days neonate is hospitalized
Total number of days neonate is hospitalized
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Hospital for Special Surgery, New York
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
