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Trial record 32 of 133 for:    Lupus AND (woman OR women OR female)

Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

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ClinicalTrials.gov Identifier: NCT02699437
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

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
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 Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia
Study Start Date : April 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Rate of positive antiphospholipid antibodies [ Time Frame: 20 weeks to 42 weeks gestational age ]
    Number of women having positive antiphospholipid antibodies per total number of women


Biospecimen Retention:   Samples Without DNA
Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Attendants of Tertiary Hospital Obstetric Outpateint Clinics and Emergency Department
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699437


Contacts
Contact: Hanaa M El-Shafiey hanaamohamed.80@gmail.com

Locations
Egypt
Obstetrics and Gynecology Department in Mansoura University Hospital Recruiting
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

Responsible Party: Mohamed Sayed Abdelhafez, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02699437     History of Changes
Other Study ID Numbers: HME
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
Preeclampsia
Antiphospholipid Antibodies

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Antibodies
Immunoglobulins
Antibodies, Antiphospholipid
Antibodies, Anticardiolipin
Immunologic Factors
Physiological Effects of Drugs