Recruiting

Pregnancy Outcome

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT00198068

Conditions

Systemic Lupus Erythematosus

Antiphospholipid Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Systemic Lupus Erythematosus

Antiphospholipid Syndrome

Study ID

NCT00198068

Start date

Sep, 2003

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1: aPL+/SLE-

Positive antiphospholipid antibodies (aPL) defined as positive LAC and/or anti cardiolipin IgG/IgM >= 40 units and/or anti-beta 2 glycoprotein I IgG or IgM >= 40 units; no SLE

Group 2: aPL+/SLE+

Positive antiphospholipid antibodies (aPL) defined as positive LAC and/or anti cardiolipin IgG/IgM >= 40 units and/or anti-beta 2 glycoprotein I IgG or IgM >= 40 units AND SLE defined as four or more American College of Rheumatology criteria for SLE.

Group 3: aPL-/SLE+

No antiphospholipid antibodies; SLE defined as four or more American College of Rheumatology criteria for SLE.

Group 4: aPL-/SLE-

Healthy controls: no antiphospholipid antibodies; no SLE

Primary outcome measure

  • Otherwise unexplained fetal death occurring after 12 weeks gestation [ Time Frame: End of pregnancy ]
  • Neonatal death [ Time Frame: Time of neonatal death ]
  • Preterm delivery prior to 36 weeks' gestation [ Time Frame: End of pregnancy ]
  • Small for gestational age (SGA) <5th %ile [ Time Frame: End of pregnancy ]

Central Contacts and Locations

Central contacts

Marta M. Guerra, MS

212-774-7361guerram@hss.edu

Locations

NYU Langone Medical Center/Hospital for Joint Diseases

Recruiting

New York, New York, United States, 10016

Contacts

Marta M Guerra, MS

212-774-7361guerram@hss.edu

Principal Investigator:

Jill P. Buyon, M.D.

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Marta M Guerra, MS

212-774-7361guerram@hss.edu

Principal Investigator:

Michael D. Lockshin, M.D.

University of Utah Salt Lake City

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Tyler R Cavin

801-585-7617tyler.cavin@hsc.utah.edu

Principal Investigator:

Ware Branch, M.D.

Mt. Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2K4

Contacts

Karen Spitzer

416-506-9203kspitzer@triofertility.com

Principal Investigator:

Carl Laskin, M.D.

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Apr 28, 2026

Last verified

Mar, 2026

Keywords

  • Pregnancy outcomes
  • Systemic lupus erythematosus
  • Antiphospholipid syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-04-28.