Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia - Full Text View

Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

This study is currently recruiting participants.
Verified by University of Mississippi Medical Center, December 2007

Sponsored by:	University of Mississippi Medical Center
Information provided by:	University of Mississippi Medical Center
ClinicalTrials.gov Identifier:	NCT00583635

Purpose

Use of Juice+ food supplements, when initiated in the first trimester and used continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy complications. Study sponsored by National Safety Associates, LLC.

Condition

Preeclampsia
Pregnancy Loss

MedlinePlus related topics:

Antioxidants

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Official Title:	Minimizing Early Pregnancy Oxidative Stress to Maximize Healthy Pregnancy Outcome: Reducing Preeclampsia and Reproductive Loss With Antioxidant-Rich Tablet Supplementation Initiated in the First Trimester

Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:

Development of preeclampsia during pregnancy [ Time Frame: Preeclampsia at any time during gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The observed incidence of preterm labor, premature rupture of membranes, perinatal loss [ Time Frame: First, second and third trimester ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood to be analyzed for various markers, then discarded, none to be retained.

Estimated Enrollment:	600
Study Start Date:	May 2004
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts

Low Risk Pregnancy, Placebo

Low Risk Pregnancy, Active Food Supplement

High Risk Pregnancy, Placebo

High Risk Pregnancy, Active Food Supplement

Detailed Description:

Not desired

Eligibility

Ages Eligible for Study:	18 Years to 44 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients cared for in the University of Mississippi Medical Center

Criteria

Inclusion Criteria:

Pregnant Patients seen in first trimester with low or high risk pregnancy

Exclusion Criteria:

Pregnant patients first seen after the first trimester
Unlikely to continue care in our system
Unwilling to comply with rigor of taking food supplements throughout gestation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583635

Contacts


Contact: James N Martin, Jr, MD	601-984-6719	jnmartin@ob-gyn.umsmed.edu

Locations


United States, Mississippi
	University of Mississippi Medical Center	Recruiting
	Jackson, Mississippi, United States, 39216
	Contact: James N Martin, Jr., MD 601-984-6719 jnmartin@ob-gyn.umsmed.edu
	Contact: Pamela Tazik 601-815-5007 ptazik@dor.umsmed.edu
	Principal Investigator: James N Martin, Jr, MD

Sponsors and Collaborators

University of Mississippi Medical Center

Investigators


Principal Investigator:	James N Martin, Jr., MD	University of Mississippi Medical Center

More Information

Responsible Party:	Professor OBGYN, University of Mississippi Medical Center ( James N. Martin, Jr., MD )
Study ID Numbers:	IRB File # 2003-0119
First Received:	December 20, 2007
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00583635
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:

Preeclampsia

Prevention

Food Supplement

Study placed in the following topic categories:

Hypertension, Pregnancy-Induced

Pregnancy Complications

Eclampsia

Pregnancy toxemia /hypertension

Stress

Pre-Eclampsia

Healthy

Preeclampsia

Hypertension

ClinicalTrials.gov processed this record on September 05, 2008