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

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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

Tracking Information
First Submitted Date April 13, 2018
First Posted Date April 23, 2018
Last Update Posted Date November 6, 2018
Actual Study Start Date April 24, 2018
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 20, 2018)
The number of participants who will have impaired placental doppler indices [ Time Frame: within 2 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03505840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Value of Placental Vascularization and Placental Volume in Pregnancy in APLS
Official Title TheValue of Placental Vascularization Indices and Placental Volume in Pregnancies With Antiphospholipid Syndrome for Prediction of Neonatal Outcome"
Brief Summary Antiphospholipid antibodies are autoantibodies directed against phospholipid‐binding proteins. Among these groups of antibodies, lupus anticoagulant (LA) and anticardiolipin antibodies (aCL)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

Singleton pregnancy.

  • Gestational age of 34‐37 weeks.
  • Pregnant women with antiphospholipid syndrome
Condition Antiphospholipid Syndrome in Pregnancy
Intervention Diagnostic Test: Ultrasound with Doppler and 3D technology
ultrasound will be made to pregnant females in 3rd trimester with doppler and 3D technology
Study Groups/Cohorts
  • antiphospholipid group
    pregnant ladies in the third trimester who have antiphospholipid syndrome
    Intervention: Diagnostic Test: Ultrasound with Doppler and 3D technology
  • control group
    pregnant ladies in the third trimester who have no medical disorders with pregnancy
    Intervention: Diagnostic Test: Ultrasound with Doppler and 3D technology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 20, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 10, 2019
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: pregnant females with antiphospholipid syndrome
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mahmoud Alalfy 01002611058 mahmoudalalfy@ymail.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03505840
Other Study ID Numbers vocal in placenta
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The research data will be published
Responsible Party Mahmoud Alalfy, Aljazeera Hospital
Study Sponsor Aljazeera Hospital
Collaborators Cairo University
Investigators
Principal Investigator: Mahmoud Alalfy Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
PRS Account Aljazeera Hospital
Verification Date November 2018