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

Sponsor
Aljazeera Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03505840
Collaborator
Cairo University (Other)
100
Enrollment
1
Location
29.6
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Apr 24, 2018
Anticipated Primary Completion Date :
Sep 4, 2020
Anticipated Study Completion Date :
Oct 10, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The number of participants who will have impaired placental doppler indices [within 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Algazeerah Giza Egypt

Sponsors and Collaborators

  • Aljazeera Hospital
  • Cairo University

Investigators

  • Principal Investigator: Mahmoud Alalfy, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud Alalfy, Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital
ClinicalTrials.gov Identifier:
NCT03505840
Other Study ID Numbers:
  • vocal in placenta
First Posted:
Apr 23, 2018
Last Update Posted:
Jan 27, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Antiphospholipid Syndrome
Syndrome
Neovascularization, Pathologic

Study Results

No Results Posted as of Jan 27, 2020