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NCT02699437 Clinical Trial

Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

Preeclampsia Clinical Trial

Official title:
Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02699437
Other study ID # HME
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2019

Study information
Verified date October 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Testing for antiphospholipid antibodies
Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant

Locations
Country Name City State
Egypt Obstetrics and Gynecology Department in Mansoura University Hospital Mansoura Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mohamed Sayed Abdelhafez

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of positive antiphospholipid antibodies Number of women having positive antiphospholipid antibodies per total number of women 20 weeks to 42 weeks gestational age
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