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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03882099
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 6.5
• Patients Per Site Per Month: 76.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency; Pre-Eclampsia; Eclampsia, Antepartum	Diagnostic Test: Determination of Vitamin D by ELISA

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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Vitamin D Level in Patients With Pre-eclampsia, Eclampsia and Normal Full Term Pregnant
• Actual Study Start Date: Mar 17, 2019
• Anticipated Primary Completion Date: Sep 17, 2019
• Anticipated Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Pregnant women with pre-eclampsia	Diagnostic Test: Determination of Vitamin D by ELISA; Blood samples
Pregnant women with eclampsia	Diagnostic Test: Determination of Vitamin D by ELISA; Blood samples
Normotensive pregnant women	Diagnostic Test: Determination of Vitamin D by ELISA; Blood samples

Outcome Measures

Primary Outcome Measures

1. To compare vitamin D levels in the three groups [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	12573

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yahia El-Faissal, Dr, Cairo University
• ClinicalTrials.gov Identifier: NCT03882099
• Other Study ID Numbers: 173019OBGYN
• First Posted: Mar 20, 2019
• Last Update Posted: Mar 20, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Eclampsia; Pre-Eclampsia; Vitamin D Deficiency; Vitamin D

Study Results

No Results Posted as of Mar 20, 2019