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

• Conditions: Eclampsia, Antepartum; Pre-Eclampsia; Vitamin D Deficiency
• Interventions: Diagnostic Test: Determination of Vitamin D by ELISA

• Registration Number: NCT03882099
• Lead Sponsor: Cairo University

Brief 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.

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.

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-17
• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-03-17
• Last Update Submitted: 2019-03-17
• Study First Posted: 2019-03-20
• Last Update Posted: 2019-03-20
• Primary Completion: 2019-09-17
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women with pre-eclampsia	Determination of Vitamin D by ELISA	-
Pregnant women with eclampsia	Determination of Vitamin D by ELISA	-
Normotensive pregnant women	Determination of Vitamin D by ELISA	-

Primary Outcome Measures

Name	Time	Method
To compare vitamin D levels in the three groups	6 months

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt