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The Value of Placental Vascularization and Placental Volume in Pregnancy in APLS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03505840
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Mahmoud Alalfy, Aljazeera Hospital

Brief Summary:
Antiphospholipid antibodies are autoantibodies directed against phospholipid‐binding proteins. Among these groups of antibodies, lupus anticoagulant (LA) and anticardiolipin antibodies (aCL)

Condition or disease Intervention/treatment
Antiphospholipid Syndrome in Pregnancy Diagnostic Test: Ultrasound with Doppler and 3D technology

Detailed Description:
APLS can be primary when no evidence of autoimmune disease is found, or secondary to autoimmune processes like systemic lupus erythematous (SLE) in a 40% of the cases.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TheValue of Placental Vascularization Indices and Placental Volume in Pregnancies With Antiphospholipid Syndrome for Prediction of Neonatal Outcome"
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
antiphospholipid group
pregnant ladies in the third trimester who have antiphospholipid syndrome
Diagnostic Test: Ultrasound with Doppler and 3D technology
ultrasound will be made to pregnant females in 3rd trimester with doppler and 3D technology

control group
pregnant ladies in the third trimester who have no medical disorders with pregnancy
Diagnostic Test: Ultrasound with Doppler and 3D technology
ultrasound will be made to pregnant females in 3rd trimester with doppler and 3D technology




Primary Outcome Measures :
  1. The number of participants who will have impaired placental doppler indices [ Time Frame: within 2 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant females with antiphospholipid syndrome
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Singleton pregnancy.

  • Gestational age of 34‐37 weeks.
  • Pregnant women with antiphospholipid syndrome
Criteria

Inclusion Criteria:

  • Singleton pregnancy.

    • Gestational age of 34‐37 weeks.
    • Pregnant women with antiphospholipid syndrome

Exclusion Criteria:

  • Twin or multiple pregnancies.
  • Congenital fetal anomalies.
  • Gestational age of less than 34.
  • Gestational age of more than 37.
  • Women with placental or umbilical artery anomalies.
  • Antepartum hemorrhage (placental abruption, placenta previa and vasa previa).
  • Posterior placenta.
  • History of rupture of membrane.
  • Patient refusal or fall outs.

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): NCT03505840


Contacts
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Contact: Mahmoud Alalfy 01002611058 mahmoudalalfy@ymail.com

Locations
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Egypt
Algazeerah Recruiting
Giza, Egypt
Contact: Mahmoud Alalfy, master    +201002611058    mahmoudalalfy@ymail.com   
Contact: Ahmed Elgazzar, M.D    +201014005959      
Principal Investigator: Mahmoud Alalfy, master         
Sponsors and Collaborators
Aljazeera Hospital
Cairo University
Investigators
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Principal Investigator: Mahmoud Alalfy Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

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Responsible Party: Mahmoud Alalfy, Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT03505840     History of Changes
Other Study ID Numbers: vocal in placenta
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The research data will be published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Syndrome
Neovascularization, Pathologic
Disease
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Metaplasia