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

NCT ID: NCT03882099

Last Updated: 2019-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-17

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vitamin D Deficiency Pre-Eclampsia Eclampsia, Antepartum

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women with pre-eclampsia

Determination of Vitamin D by ELISA

Intervention Type DIAGNOSTIC_TEST

Blood samples

Pregnant women with eclampsia

Determination of Vitamin D by ELISA

Intervention Type DIAGNOSTIC_TEST

Blood samples

Normotensive pregnant women

Determination of Vitamin D by ELISA

Intervention Type DIAGNOSTIC_TEST

Blood samples

Interventions

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Determination of Vitamin D by ELISA

Blood samples

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Twin pregnancy
* Other medical conditions during pregnancy
* Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yahia El-Faissal

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Yahia El-Faissal, M.D.

Role: primary

+201001844020

Other Identifiers

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173019OBGYN

Identifier Type: -

Identifier Source: org_study_id

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