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A Retrospective Review of the Seasonality of Pre-Eclampsia
This study is currently recruiting participants.
Verified by Oklahoma State University Center for Health Sciences, January 2009
First Received: January 20, 2009   No Changes Posted
Sponsored by: Oklahoma State University Center for Health Sciences
Information provided by: Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT00826696
  Purpose

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.


Condition
Preeclampsia

U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Retrospective
Official Title: A Retrospective Review of the Seasonality of Pre-Eclampsia

Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • Number of women per month who had a diagnosis of pre-eclampsia at OSU Medical Center when they delivered a baby. [ Time Frame: Data assessed from patient charts retrospectively ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 500
Study Start Date: January 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Women of all races who were admitted to OSUMC for delivery of a baby (both cesarean and vaginal deliveries) between 1/1/05 and 12/31/07, with or without a diagnosis of pre-eclampsia.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826696

Contacts
Contact: Nicole Bullock, CO 918-261-9638 nckbullock@hotmail.com
Contact: Sarah McCoy, PhD 918-274-0639 sjmccoy98@aol.com

Locations
United States, Oklahoma
Oklahoma State University Medical Center Recruiting
Tulsa, Oklahoma, United States, 74127
Contact: Teri Bycroft, MSN         teri.bycroft@okstate.edu    
Principal Investigator: Nicole Bullock, DO            
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Nicole Bullock, DO OSU Center for Health Sciences
  More Information

No publications provided

Responsible Party: OSUCHS Department of Obstetrics and Gynecology ( Nicole Bullock, D.O. )
Study ID Numbers: 2008021
Study First Received: January 20, 2009
Last Updated: January 20, 2009
ClinicalTrials.gov Identifier: NCT00826696     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
preeclampsia

Study placed in the following topic categories:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Pre-Eclampsia
Preeclampsia
Hypertension

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Pre-Eclampsia

ClinicalTrials.gov processed this record on May 06, 2009