Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

October 27, 2023 updated by: Mohamed Sayed Abdelhafez
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35111
        • Obstetrics and Gynecology Department in Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Attendants of Tertiary Hospital Obstetric Outpateint Clinics and Emergency Department

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 weeks to 42 weeks gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Sayed Abdelhafez

Investigators

  • Principal Investigator: Hanaa M El-Shafiey, 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 Director: Mohamed S Abdelhafez, Dr, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimated)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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