NCT03882099

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 17, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 17, 2019

Last Update Submit

March 17, 2019

Conditions

Vitamin D DeficiencyPre-EclampsiaEclampsia, Antepartum

Outcome Measures

Primary Outcomes (1)

  • To compare vitamin D levels in the three groups

    6 months

Study Arms (3)

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

Determination of Vitamin D by ELISADIAGNOSTIC_TEST

Blood samples

Normotensive pregnant womenPregnant women with eclampsiaPregnant women with pre-eclampsia

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12573, Egypt

RECRUITING

MeSH Terms

Conditions

Vitamin D DeficiencyPre-EclampsiaEclampsia

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesHypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 20, 2019

Study Start

March 17, 2019

Primary Completion

September 17, 2019

Study Completion

October 1, 2019

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations

EG(1)