RightFit
RecruitingPhase not listed

Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether certain blood proteins can predict pregnancy problems. It includes pregnant patients with lupus (SLE), antiphospholipid syndrome (APS), or aPL antibodies, as well as a comparison group. Researchers observe patients rather than test a treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a living pregnancy inside the womb, confirmed by a pregnancy test. Be no more than 12 weeks pregnant without aPL antibodies, or 18 weeks with them.
  • Be age 18–45 and able to agree to join, or under 18 with a parent's consent.
  • Have a hematocrit above 26%. This test measures how much of your blood is made up of red blood cells.
  • For the aPL-positive group, listed blood test results include aCL or anti-β2GPI antibody levels of at least 40 GPL units for IgG or 40 MPL units for IgM, and a positive lupus anticoagulant (LAC) test.
  • For the comparison group: have had at least one successful pregnancy, no pregnancy loss at 10 weeks or later, and no more than one miscarriage before 10 weeks.
  • For the comparison group: have no past positive aPL test at a local lab and no positive aPL test at the study lab during screening.
  • For the comparison group: do not currently smoke.
  • For the comparison group: have no health problems that need ongoing treatment.

Who can't join

  • Had type 1 or type 2 diabetes before pregnancy.
  • Have, or may have, an inherited lack of complement proteins, which are part of the immune system. This is defined by a CH50 blood test result of zero.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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% * For APL positive: * aCL: IgG \>= 40 GPL units; IgM \>= 40 MPL units * Positive LAC (RVVT, Kaolin, dilute TTI or PTT LA) * Anti-β2GPI: IgG \>= 40 GPL units; IgM \>= 40 MPL units * For control subjects: * At least one successful pregnancy * No history of fetal death (death of conceptus ≥ 10 weeks' gestation) * No more than 1 miscarriage \< 10 weeks' gestation * No history of positive aPL in local lab or positive aPL in core labs at screening * Not currently a smoker * No medical problems requiring chronic treatment Exclusion Criteria: * Diabetes mellitus (Type I and Type II) antedating pregnancy * Known or suspected hereditary complement deficiency (defined by CH50 = 0)

Study sites (8)

IL

MD

NY

OK

UT