Cardiovascular DiseasesNCT00241683
Fetal Growth Restriction & Maternal Cardiovascular Risk
An observational study of Cardiovascular Diseases and Heart Diseases, run by The University of Texas Health Science Center, Houston.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- 704 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who were 4 to 12 years postpartum
Who may be able to join
- 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
Who cannot join
- women who had preeclampsia
- women who had prepregnancy hypertension
- women who had diabetes
- women who were currently pregnant or reported a prepregnancy chronic condition
About this study
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.
Read the detailed description
BACKGROUND:
Intrauterine growth restriction leads to major neonatal morbidity and mortality. Moreover, recent birth registry studies have suggested that women bearing IUGR babies may have an elevated risk of cardiovascular disease.
DESIGN NARRATIVE:
This cohort study tested whether exposed women, with a previous intrauterine growth restriction (IUGR) baby, versus unexposed women, with a pregnancy not complicated by IUGR, had elevations in markers of cardiovascular risk. Exposure was defined among a geographically defined cohort as having had a singleton baby in the < 5 %tile of weight for gestational age, in the absence of pre-pregnancy diabetes., hypertension, renal disease, or hypertension in pregnancy; controls had a singleton in the > 20%tile. Four to twelve years postpartum, women were assessed for multiple markers of cardiovascular risk, including blood pressure, lipids, adiposity, glucose and insulin, homocysteine and folate, markers of inflammation, markers of endothelial function, markers of angiogenesis, and markers of vascular function. Data analysis consisted of ANOVA and ANCOVA analyses comparing the outcomes of cardiovascular markers among exposed and unexposed women.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 4 to 12 years after pregnancy
Triglycerides and LDL cholesterol
Measured: 4 to 12 years after pregnancy
Secondary outcomes (1)
Glucose
Measured: 4 to 12 years after pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startAug 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Roberta Ness, Dean, SPH, The University of Texas Health Science Center, Houston
- Investigators
- Roberta B. Ness, MD, MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241683
- Sponsor's protocol ID
- 1307
- Other IDs
- 5R01HL076532-03
- Status last verified
- Jan 2013
- First submitted
- 17 Oct 2005
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21252733McClure 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.
PubMed 21164507McClure 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.
PubMed 21404071
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Growth Restriction & Maternal Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT00241683
- Acronym / sponsor ID
- 1307
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
Intrauterine growth restriction leads to major neonatal morbidity and mortality. Moreover, recent birth registry studies have suggested that women bearing IUGR babies may have an elevated risk of cardiovascular disease.
DESIGN NARRATIVE:
This cohort study tested whether exposed women, with a previous intrauterine growth restriction (IUGR) baby, versus unexposed women, with a pregnancy not complicated by IUGR, had elevations in markers of cardiovascular risk. Exposure was defined among a geographically defined cohort as having had a singleton baby in the < 5 %tile of weight for gestational age, in the absence of pre-pregnancy diabetes., hypertension, renal disease, or hypertension in pregnancy; controls had a singleton in the > 20%tile. Four to twelve years postpartum, women were assessed for multiple markers of cardiovascular risk, including blood pressure, lipids, adiposity, glucose and insulin, homocysteine and folate, markers of inflammation, markers of endothelial function, markers of angiogenesis, and markers of vascular function. Data analysis consisted of ANOVA and ANCOVA analyses comparing the outcomes of cardiovascular markers among exposed and unexposed women.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who were 4 to 12 years postpartum
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- women who had preeclampsia
- women who had prepregnancy hypertension
- women who had diabetes
- women who were currently pregnant or reported a prepregnancy chronic condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure
Time frame: 4 to 12 years after pregnancy
Triglycerides and LDL cholesterol
Time frame: 4 to 12 years after pregnancy
1 secondary outcome
Glucose
Time frame: 4 to 12 years after pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
- Results publication: PubMed 21252733Catov 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.
- Results publication: PubMed 21164507McClure 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.
- Results publication: PubMed 21404071McClure 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta B. Ness, MD, MPH principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 4 to 12 years after pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00241683, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2013.