Antiphospholipid Antibodies and Fetal Growth Restriction

NCT ID: NCT01538134

Last Updated: 2015-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fetal Growth Restriction Antiphospholipid Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Patients with ultrasonographic diagnosis of fetal growth restriction.

No interventions assigned to this group

Control

Patients with normal pregnancies at term.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Coordinator of Research & Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osvaldo Reyes, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Hospital, Panama

Locations

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Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Site Status

Countries

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Panama

Other Identifiers

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MHST2012-01B

Identifier Type: -

Identifier Source: org_study_id

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