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CompletedNCT02699437Updated Oct 30, 2023

Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

An observational study in Preeclampsia, sponsored by Mohamed Sayed Abdelhafez. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-10-30.

Sponsored by Mohamed Sayed Abdelhafez · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
200
Ages
20 Years to 35 Years
Sex
Female
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Study 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

Read the detailed description

For all women included in the study, blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant. The clinical details of all women will be collected by reviewing their hospital and prenatal records. The following clinical characteristics will be evaluated: maternal age, previous gestations, parity, past or family history of preeclampsia, gestational age at the onset of preeclampsia, gestational age at delivery and birth weight. The following pregnancy and delivery complications will be assessed: placental insufficiency, intrauterine growth restriction, fetal loss (stillbirth) and early neonatal death.

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Conditions studied

  • Preeclampsia

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Keywords

  • Preeclampsia
  • Antiphospholipid Antibodies
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In context

Pre-Eclampsia

904 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.

This study's enrollment of 200 is above the median of 160 across 389 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Mohamed Sayed Abdelhafez is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Attendants of Tertiary Hospital Obstetric Outpateint Clinics and Emergency Department

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women with preeclampsia.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
200 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • OtherTesting for antiphospholipid antibodies

    Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant

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What researchers measure

Primary outcomes

  1. Rate of positive antiphospholipid antibodies

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

    Time frame: 20 weeks to 42 weeks gestational age

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Study locations

1 site
  • Obstetrics and Gynecology Department in Mansoura University Hospital
    Al Mansurah, Dakahlia Governorate 35111, Egypt
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Dec 2019, 35 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2016
First posted
Mar 4, 2016
StartActual
Jan 1, 2017
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Oct 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02699437
Lead sponsor
Mohamed Sayed Abdelhafez
Responsible party
Mohamed Sayed Abdelhafez (Dr, Mansoura University) — Sponsor-investigator
First posted
Mar 4, 2016
Start date
Jan 1, 2017
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Oct 30, 2023

Study contacts

Hanaa M El-Shafiey
principal investigator · Mansoura University
Mohamed S Abdelhafez, Dr
study director · Mansoura University
Alaa El-Din M El-Gohary, Dr
study director · Mansoura University
El-Said M Abd El-Hady, Prof
study chair · Mansoura University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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