A Retrospective Review of the Seasonality of Pre-Eclampsia

Preeclampsia Clinical Trial

Official title:

A Retrospective Review of the Seasonality of Pre-Eclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826696
• Other study ID #: 2008021
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: January 26, 2010
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: January 2010
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This retrospective review will will attempt to determine whether our data show a significant difference in number of deliveries of women with pre-eclampsia compared to deliveries without pre-eclampsia during certain months of the year.

Description:

This study is a retrospective review of obstetrics charts of women who gave birth at OSU Medical Center between January 01, 2005 and December 31, 2007.

Included will be patient charts of women > 18 years old who were admitted to OSUMC for delivery (both cesarean and vaginal deliveries) between 1/1/05 and 12/31/07, with and without a diagnosis of pre-eclampsia. The data collected will be recorded in a spreadsheet by month/day of delivery, and whether pre-eclampsia was a diagnosis. Also included will be total number of deliveries per month and total number of pre-eclampsia diagnoses per month. The rate of pre-eclampsia will be calculated.

A contingency table with corresponding chi square test will be performed to determine whether there is a significant relationship of the diagnosis of pre-eclampsia with seasonality, defined primarily by month. Certain data occurring during transition periods between seasons may be excluded from analyses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women who gave birth at OSU Medical Center between January 01, 2005 and December 31, 2007 and were > 18 years old who were admitted to OSUMC for delivery (both cesarean and vaginal deliveries) between 1/1/05 and 12/31/07, with and without a diagnosis of pre-eclampsia.

Exclusion Criteria:

• Females under age 18

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
United States	Oklahoma State University Medical Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women per month who had a diagnosis of pre-eclampsia at OSU Medical Center when they delivered a baby.		Data assessed from patient charts retrospectively	No