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Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

NCT ID: NCT02699437

Last Updated: 2023-10-30

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

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to determine the prevalence of positive antiphospholipid antibodies among women with preeclampsia and to determine the effect of antiphospholipid antibodies on the severity of preeclampsia and the obstetric outcomes

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Detailed Description

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For all women included in the study, blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant. The clinical details of all women will be collected by reviewing their hospital and prenatal records. The following clinical characteristics will be evaluated: maternal age, previous gestations, parity, past or family history of preeclampsia, gestational age at the onset of preeclampsia, gestational age at delivery and birth weight. The following pregnancy and delivery complications will be assessed: placental insufficiency, intrauterine growth restriction, fetal loss (stillbirth) and early neonatal death.

Conditions

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Preeclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnant women with preeclampsia

Testing for antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant) will be performed in pregnant women with preeclampsia.

Testing for antiphospholipid antibodies

Intervention Type OTHER

Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant

Interventions

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Testing for antiphospholipid antibodies

Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with preeclampsia.

Exclusion Criteria

* Women with systemic autoimmune disease.
* Women with active thromboembolic disorders.
* Women with history of previous thromboembolic disorders.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Sayed Abdelhafez

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Sayed Abdelhafez

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hanaa M El-Shafiey

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Mohamed S Abdelhafez, Dr

Role: STUDY_DIRECTOR

Mansoura University

Alaa El-Din M El-Gohary, Dr

Role: STUDY_DIRECTOR

Mansoura University

El-Said M Abd El-Hady, Prof

Role: STUDY_CHAIR

Mansoura University

Locations

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Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HME

Identifier Type: -

Identifier Source: org_study_id

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