NCT02699437

Brief Summary

The purpose of this study is to determine the prevalence of positive antiphospholipid antibodies among women with preeclampsia and to determine the effect of antiphospholipid antibodies on the severity of preeclampsia and the obstetric outcomes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

February 26, 2016

Last Update Submit

October 27, 2023

Conditions

Preeclampsia

Keywords

PreeclampsiaAntiphospholipid Antibodies

Outcome Measures

Primary Outcomes (1)

  • Rate of positive antiphospholipid antibodies

    Number of women having positive antiphospholipid antibodies per total number of women

    20 weeks to 42 weeks gestational age

Study Arms (1)

Pregnant women with preeclampsia

Testing for antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant) will be performed in pregnant women with preeclampsia.

Other: Testing for antiphospholipid antibodies

Interventions

Testing for antiphospholipid antibodiesOTHER

Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant

Pregnant women with preeclampsia

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Attendants of Tertiary Hospital Obstetric Outpateint Clinics and Emergency Department

You may qualify if:

  • Pregnant women with preeclampsia.

You may not qualify if:

  • Women with systemic autoimmune disease.
  • Women with active thromboembolic disorders.
  • Women with history of previous thromboembolic disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Antibodies, Antiphospholipid

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AutoantibodiesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hanaa M El-Shafiey

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • Mohamed S Abdelhafez, Dr

    Mansoura University

    STUDY DIRECTOR

  • Alaa El-Din M El-Gohary, Dr

    Mansoura University

    STUDY DIRECTOR

  • El-Said M Abd El-Hady, Prof

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 4, 2016

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations

EG(1)