Association Between Vitamin D Deficiency and Preeclampsia: A Case Control Study

NCT02677233 | Completed DMC

• 1 other identifier: vid-20
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

To find out if lower levels of vitamin D is more prevalent in preeclamptic women

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• vitamin D level in preeclamptic and non preeclamptic women

  six months

Study Arms (2)

preeclamptic group

1. Blood pressure: greater than or equal to 140 mmHg systolic or greater than or equal to 90 mmHg diastolic on two occasions at least 4 hours apart after 20 weeks of gestation (Roberts et al., 2013). 2. Proteinuria: protein/creatinine ratio greater than or equal to 0.3 3. In the absence of proteinuria, a new-onset hypertension with new onset of the following: * thrombocytopenia: platelet count less than 100.000/microliter * renal insufficiency: serum creatinine greater than 1.1 mg/dl * impaired liver function: elevated concentration of liver transaminases * pulmonary edema * cerebral or visual symptoms * Severe right upper quadrant or epigastric pain unresponsive to medication.

non preeclamptic group

All are normotensive with blood pressure \<140/90 with no proteinuria.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will be carried out on 90 pregnant women recruited at pre labour room at Ain Shams University Maternity Hospital. They will be divided into preeclamptic group and non preeclamptic group, 45 cases in each one

You may qualify if:

• Parity: primigravida.
• Age: 18 - 35 years.
• Singleton pregnancy.
• Gestational age: 36-40 weeks.
• No past history of any medical disorder and with no other medical complications during pregnancy

You may not qualify if:

• Women with preexisting medical conditions like rheumatoid arthritis, thyroid, hepatic or renal failure, metabolic bone disease, diabetes mellitus, malabsorption and lupus.
• History of intake of medications influencing bone, vitamin D or calcium metabolism e.g. antiepileptic, theophylline, antitubercular drugs in the last 6 months.
• Women with multiple pregnancy.
• Women with congenital fetal malformation.
• Women with known thrombophilia

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mohamed salah

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 9, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share