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Antiphospholipid Antibodies and Fetal Growth Restriction

S

Saint Thomas Hospital (HST)

Status

Unknown

Conditions

Antiphospholipid Syndrome
Fetal Growth Restriction

Study type

Observational

Funder types

Other

Identifiers

NCT01538134
MHST2012-01B

Details and patient eligibility

About

The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of fetal growth restriction (diagnosed postpartum), but this was done without solid evidence of a relation between the two or using the most common form of fetal growth restriction diagnosis (ultrasound). Our study will try to add information to this particular point.

Enrollment

90 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Gestational age between 24-34 weeks.

  • Ultrasonographic evidence of fetal growth restriction

    • Abdominal circumference < 3rd percentile.
    • Doppler with increase of placental resistance.

Exclusion criteria

  • Known antiphospholipid syndrome.
  • Known presence of antiphospholipid antibodies.
  • Patients with systemic lupus erythematosus.

Trial design

90 participants in 2 patient groups

Cases
Description:
Patients with ultrasonographic diagnosis of fetal growth restriction.
Control
Description:
Patients with normal pregnancies at term.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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