A Retrospective Review of the Seasonality of Pre-Eclampsia

This study has been completed.

Sponsor:

Information provided by:

Oklahoma State University Center for Health Sciences

ClinicalTrials.gov Identifier:

NCT00826696

First received: January 20, 2009

Last updated: January 26, 2010

Last verified: January 2010

History of Changes

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


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	A Retrospective Review of the Seasonality of Pre-Eclampsia

Resource links provided by NLM:

Genetics Home Reference related topics: preeclampsia

Genetic and Rare Diseases Information Center resources: Eclampsia

U.S. FDA Resources

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 ]


Estimated Enrollment:	500
Study Start Date:	January 2009
Study Completion Date:	July 2009
Primary Completion Date:	April 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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Nicole Bullock, D.O., OSUCHS Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier:	NCT00826696 History of Changes
Other Study ID Numbers:	2008021
Study First Received:	January 20, 2009
Last Updated:	January 26, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:


preeclampsia

Additional relevant MeSH terms:


Pre-Eclampsia Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications

ClinicalTrials.gov processed this record on September 30, 2016

To Top