Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

• Sponsor: Mohamed Sayed Abdelhafez (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02699437
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 56
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia	Other: Testing for antiphospholipid antibodies

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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: Nov 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Pregnant women with preeclampsia Testing for antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant) will be performed in pregnant women with preeclampsia.	Other: Testing for antiphospholipid antibodies; Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant

Outcome Measures

Primary Outcome Measures

1. Rate of positive antiphospholipid antibodies [20 weeks to 42 weeks gestational age]

   Number of women having positive antiphospholipid antibodies per total number of women

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansoura	Dakahlia	Egypt	35111

Sponsors and Collaborators

• Mohamed Sayed Abdelhafez

Investigators

• Principal Investigator: Hanaa M El-Shafiey, Mansoura University
• Study Director: Mohamed S Abdelhafez, Dr, Mansoura University
• Study Director: Alaa El-Din M El-Gohary, Dr, Mansoura University
• Study Chair: El-Said M Abd El-Hady, Prof, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Sayed Abdelhafez, Dr, Mansoura University
• ClinicalTrials.gov Identifier: NCT02699437
• Other Study ID Numbers: HME
• First Posted: Mar 4, 2016
• Last Update Posted: Oct 4, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Mohamed Sayed Abdelhafez, Dr, Mansoura University: Preeclampsia; Antiphospholipid Antibodies
• Additional relevant MeSH terms: Pre-Eclampsia; Antibodies; Antibodies, Antiphospholipid

Study Results

No Results Posted as of Oct 4, 2019