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A Retrospective Review of the Seasonality of Pre-Eclampsia

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ClinicalTrials.gov Identifier: NCT00826696
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : January 28, 2010
Sponsor:
Information provided by:
Oklahoma State University Center for Health Sciences

Study Description
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Brief 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.

Condition or disease
Preeclampsia

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.


Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Retrospective Review of the Seasonality of Pre-Eclampsia
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : July 2009

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826696


Locations
United States, Oklahoma
Oklahoma State University Medical Center
Tulsa, Oklahoma, United States, 74127
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Nicole Bullock, DO OSU Center for Health Sciences
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nicole Bullock, D.O., OSUCHS Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT00826696     History of Changes
Other Study ID Numbers: 2008021
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010

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

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