Antiphospholipid Antibodies and Fetal Growth Restriction | NCT01538134

Studies
Antiphospholipid Antibodies and Fetal Growth Restriction

NCT01538134

Sponsor

Saint Thomas Hospital, Panama

Status

Unknown status

Last Update Posted

Jan 5, 2015Estimated

Enrollment

90Estimated

Phase

Not provided

Conditions

Fetal Growth Restriction
Antiphospholipid Syndrome

Interventions

Not provided

Countries

Panama

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Feb 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Feb 19, 2012

First Submission Date that Met QC Criteria

Feb 22, 2012

First Posted Date

Feb 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2015

Last Update Posted Date

Jan 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Osvaldo A. Reyes T., Coordinator of Research & Development, Saint Thomas Hospital, PanamaPrincipal Investigator

Lead Sponsor

Saint Thomas Hospital, PanamaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		Patients with ultrasonographic diagnosis of fetal growth restriction.
Control		Patients with normal pregnancies at term.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lupus anticoagulant	Number of cases positive for Lupus Anticoagulant.	8 months
Anticardiolipin antibodies	Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.	10 months
B2 Glycoprotein I	Number of cases with levels of B2 Glycoprotein I > 99%	10 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pregnant patients admitted for fetal growth restriction (cases) and normal patients in labor at term (controls).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Osvaldo Reyes, MD	Saint Thomas Hospital, Panama	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Thomas Maternity Hospital		Panama City	Provincia de Panamá		Panama

Condition Browse Module

MeSH Terms

ID	Term
D005317	Fetal Growth Retardation
D016736	Antiphospholipid Syndrome

Ancestor Terms

ID	Term
D005315	Fetal Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided