NCT03505840

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

April 13, 2018

Last Update Submit

January 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of participants who will have impaired placental doppler indices

    within 2 months

Study Arms (2)

antiphospholipid group

pregnant ladies in the third trimester who have antiphospholipid syndrome

Diagnostic Test: Ultrasound 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

Interventions

ultrasound will be made to pregnant females in 3rd trimester with doppler and 3D technology

antiphospholipid groupcontrol group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant females with antiphospholipid syndrome
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Singleton pregnancy. * Gestational age of 34-37 weeks. * Pregnant women with antiphospholipid syndrome

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

UltrasonographyEchocardiography, Doppler

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisEchocardiographyCardiac Imaging TechniquesUltrasonography, DopplerHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Mahmoud Alalfy

    Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 23, 2018

Study Start

April 24, 2018

Primary Completion

September 4, 2020

Study Completion

October 10, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

The research data will be published

Locations