CClinicalTrials.gg
Status unknownNCT03882099Updated Mar 20, 2019

Vitamin D Level and Its Relation to Pre-eclampsia and Eclampsia

An observational study in Vitamin D Deficiency, Pre-Eclampsia and Eclampsia, Antepartum, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

To compare 25(OH)D level in patients with pre-eclampsia, eclampsia and normotensive pregnant women as well as to study the prevalence of Vitamin D deficiency among the 3 groups.

Read the detailed description

200 patients with pre-eclampsia, 100 with eclampsia and 200 normotensive pregnant controls attending Delivery/emergency department in Kasr Al Ainy hospital will be included in the study (from March 2019 till September 2019). 25(OH) D level will be measured for the three groups.

  • Preeclampsia is defined as systolic BP >140 and/or diastolic BP>90 on two occasions, 4 hours apart in pregnant females>20 weeks, plus proteinuria >/= 1+ urine dipstick protein.
  • Eclampsia defined as tonic-clonic seizures in women with pre-eclampsia.
  • Controls are normotensive pregnant females with no proteinuria and no other medical disorders.
  • The determination of 25(OH) D is based on a competitive enzyme-linked immunosorbant assay (ELISA) using the 25(OH)D3/D2 ELISA system (ORGENTIC DIAGNOSTIKA GmbH, Germany)

Inclusion criteria:

Age 20-35 years Gestational age 30-40 weeks

Exclsion criteria:

Twin pregnancy Other medical conditions during prrgnancy Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment.

02

Conditions studied

  • Vitamin D Deficiency
  • Pre-Eclampsia
  • Eclampsia, Antepartum
03

In context

Eclampsia

328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.

This study's planned enrollment of 500 is above the median of 158 across 146 observational studies indexed under Eclampsia.

Browse Eclampsia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

200 patients with pre-eclampsia, 100 with eclampsia and 200 normotensive pregnant controls attending Delivery/emergency department in Kasr Al Ainy hospital will be included in the study

Inclusion criteria

  • Age 20-35 years
  • Gestational age 30-40 weeks

Exclusion criteria

Exclusion Criteria:

  • Twin pregnancy
  • Other medical conditions during pregnancy
  • Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pregnant women with pre-eclampsia

    Diagnostic Test: Determination of Vitamin D by ELISA

  • Pregnant women with eclampsia

    Diagnostic Test: Determination of Vitamin D by ELISA

  • Normotensive pregnant women

    Diagnostic Test: Determination of Vitamin D by ELISA

Interventions

  • Diagnostic testDetermination of Vitamin D by ELISA

    Blood samples

06

What researchers measure

Primary outcomes

  1. To compare vitamin D levels in the three groups

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Cairo University
    Cairo, 12573, Egypt
    • Yahia El-Faissal, M.D. · Contact · yahiaelfaissal@gmail.com · +201001844020
    • Omneya M Osman, M.D. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Publication in journals and presentation in conferences

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03882099
Lead sponsor
Cairo University
Responsible party
Yahia El-Faissal (Dr, Cairo University) — Principal investigator
First posted
Mar 20, 2019
Start date
Mar 17, 2019
Primary completion
Sep 17, 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Mar 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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