Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

Completed

• Conditions: Preeclampsia
• Interventions: Other: Testing for antiphospholipid antibodies

• Registration Number: NCT02699437
• Lead Sponsor: Mohamed Sayed Abdelhafez

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-04
• Study Start: 2017-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of positive antiphospholipid antibodies	20 weeks to 42 weeks gestational age	Number of women having positive antiphospholipid antibodies per total number of women

Trial Locations

Locations (1)

Obstetrics and Gynecology Department in Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt