Actively Recruiting
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Led by Hospital for Special Surgery, New York · Updated on 2026-04-28
700
Participants Needed
10
Research Sites
1226 weeks
Total Duration
On this page
Sponsors
H
Hospital for Special Surgery, New York
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient pregnant with live intrauterine pregnancy confirmed by elevated beta-HCG and gestational age ≤ 12 weeks if without aPL antibodies or ≤ 18 weeks if with aPL antibodies
- Age between 18 and 45 years and able to give informed consent (or under 18 with parental consent)
- Hematocrit greater than 26%
- For aPL positive patients: positive aCL IgG ≥ 40 GPL units or IgM ≥ 40 MPL units, positive lupus anticoagulant, or positive anti-β2GPI IgG ≥ 40 GPL units or IgM ≥ 40 MPL units
- For control subjects: at least one successful pregnancy, no history of fetal death at or beyond 10 weeks gestation, no more than one miscarriage before 10 weeks gestation, no history of positive aPL tests locally or at screening, non-smoker, and no medical problems requiring chronic treatment
You will not qualify if you...
- Diabetes mellitus (Type I or Type II) diagnosed before pregnancy
- Known or suspected hereditary complement deficiency defined by CH50 = 0
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Completed
2
University of Chicago
Chicago, Illinois, United States, 60637
Completed
3
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Completed
4
NYU Langone Medical Center/Hospital for Joint Diseases
New York, New York, United States, 10016
Actively Recruiting
5
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
6
Columbia University Medical Center
New York, New York, United States, 10032
Completed
7
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Completed
8
University of Utah Salt Lake City
Salt Lake City, Utah, United States, 84132
Actively Recruiting
9
Mt. Sinai Hospital
Toronto, Ontario, Canada, M5G 2K4
Actively Recruiting
10
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Completed
Research Team
M
Marta M. Guerra, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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