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

TheValue of Placental Vascularization Indices and Placental Volume in Pregnancies With Antiphospholipid Syndrome for Prediction of Neonatal Outcome"

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

Study Overview

• Status: Unknown
• Conditions: Antiphospholipid Syndrome in Pregnancy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Algazeerah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Singleton pregnancy.

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of participants who will have impaired placental doppler indices	within 2 months

Collaborators and Investigators

• Sponsor: Aljazeera Hospital
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Anticipated): September 4, 2020
• Study Completion (Anticipated): October 10, 2020

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease; Metaplasia; Syndrome; Neovascularization, Pathologic; Antiphospholipid Syndrome
• Other Study ID Numbers: vocal in placenta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The research data will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No