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

NCT03505840 — Unknown, 100 participants, Aljazeera Hospital

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

Registry	NCT03505840
Status	Unknown
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Aljazeera Hospital (Other); collaborators: Cairo University
Conditions	Antiphospholipid Syndrome in Pregnancy
Interventions	Ultrasound with Doppler and 3D technology (Diagnostic test)
Dates	start 2018-04-24, primary completion 2020-09-04 (estimated), completion 2020-10-10 (estimated), first posted 2018-04-23, last updated 2020-01-27
Locations	1 site in Egypt

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
antiphospholipid group		Diagnostic Test: Ultrasound with Doppler and 3D technology	pregnant ladies in the third trimester who have antiphospholipid syndrome
control group		Diagnostic Test: Ultrasound with Doppler and 3D technology	pregnant ladies in the third trimester who have no medical disorders with pregnancy

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 40 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Algazeerah	Giza	Egypt	Recruiting

+Investigators

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

My Notes

Public

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