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

Antiphospholipid Syndrome in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03505840
• Other study ID #: vocal in placenta
• Status: Recruiting
• Start date: April 24, 2018
• Est. completion date: October 10, 2020

Study information

• Verified date: January 2020
• Source: Aljazeera Hospital
• Contact: Mahmoud Alalfy
• Phone: 01002611058
• Email: mahmoudalalfy[@]ymail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 10, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Antiphospholipid Syndrome in Pregnancy
• Neovascularization, Pathologic
• Syndrome

Intervention

Diagnostic Test:
• Ultrasound with Doppler and 3D technology
ultrasound will be made to pregnant females in 3rd trimester with doppler and 3D technology

Locations

Country	Name	City	State
Egypt	Algazeerah	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Aljazeera Hospital	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants who will have impaired placental doppler indices		within 2 months