What this study is
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.
Study details
- Sponsor
- Hospital for Special Surgery, New York
- Conditions
- Systemic Lupus Erythematosus · Antiphospholipid Syndrome
- Enrolling
- 700 people
- Starts
- 2003-09
- Est. completion
- 2027-03
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- Diabetes mellitus (Type I and Type II) antedating pregnancy
- Known or suspected hereditary complement deficiency (defined by CH50 = 0)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
4 openNYU Langone Medical Center/Hospital for Joint Diseases
New York, New York, United States
- Marta M Guerra, MS · Contact212-774-7361guerram@hss.edu
- Jill P. Buyon, M.D. · Principal investigator
RecruitingHospital for Special Surgery
New York, New York, United States
- Marta M Guerra, MS · Contact212-774-7361guerram@hss.edu
- Michael D. Lockshin, M.D. · Principal investigator
- Lisa R. Sammaritano, M.D. · Principal investigator
RecruitingUniversity of Utah Salt Lake City
Salt Lake City, Utah, United States
- Tyler R Cavin · Contact801-585-7617tyler.cavin@hsc.utah.edu
- Ware Branch, M.D. · Principal investigator
- Flint Porter, M.D. · Principal investigator
RecruitingNorthwestern University
Chicago, Illinois, United States
CompletedUniversity of Chicago
Chicago, Illinois, United States
CompletedJohns Hopkins Hospital
Baltimore, Maryland, United States
CompletedColumbia University Medical Center
New York, New York, United States
CompletedOklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Completed
2 sites outside the US
Mt. Sinai Hospital
Toronto, Ontario, Canada
- Karen Spitzer · Contact416-506-9203kspitzer@triofertility.com
- Carl Laskin, M.D. · Principal investigator
RecruitingGuy's & St Thomas' NHS Foundation Trust
London, United Kingdom
Completed
Study team
Sponsor
Hospital for Special Surgery, New York
Study ID 2014-309
Principal investigator
Jane E. Salmon, M.D.
Hospital for Special Surgery, New York
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.