NCT00241683

Brief Summary

To determine whether or not women with a history of having a baby with intrauterine growth retardation (IUGR) was more likely to have risk factors for cardiovascular disease versus women with a pregnancy not complicated by IUGR.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
704

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2005

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

3.7 years

First QC Date

October 17, 2005

Last Update Submit

January 18, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    4 to 12 years after pregnancy

  • Triglycerides and LDL cholesterol

    4 to 12 years after pregnancy

Secondary Outcomes (1)

  • Glucose

    4 to 12 years after pregnancy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who were 4 to 12 years postpartum

You may qualify if:

  • women 4 to 12 years after delivery of singleton infant
  • women who gave birth between 1997 and 2002 at Magee-Womens Hospital in Pittsburgh, Pennsylvania

You may not qualify if:

  • women who had preeclampsia
  • women who had prepregnancy hypertension
  • women who had diabetes
  • women who were currently pregnant or reported a prepregnancy chronic condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Catov JM, Dodge R, Yamal JM, Roberts JM, Piller LB, Ness RB. Prior preterm or small-for-gestational-age birth related to maternal metabolic syndrome. Obstet Gynecol. 2011 Feb;117(2 Pt 1):225-232. doi: 10.1097/AOG.0b013e3182075626.

  • McClure CK, Bodnar LM, Ness R, Catov JM. Accuracy of maternal recall of gestational weight gain 4 to 12 years after delivery. Obesity (Silver Spring). 2011 May;19(5):1047-53. doi: 10.1038/oby.2010.300. Epub 2010 Dec 16.

  • McClure CK, Catov J, Ness R, Schwarz EB. Maternal visceral adiposity by consistency of lactation. Matern Child Health J. 2012 Feb;16(2):316-21. doi: 10.1007/s10995-011-0758-0.

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Study Officials

  • Roberta B. Ness, MD, MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean - School of Public Health

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 19, 2005

Study Start

August 1, 2005

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

January 21, 2013

Record last verified: 2013-01