The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
NCT ID: NCT01888770
Last Updated: 2016-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2011-08-31
2017-09-30
Brief Summary
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Detailed Description
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The investigators have therefore designed the EPOCH study to investigate whether those individuals born to hypertensive pregnancies and/or to a preterm birth demonstrate differences in the cardiovascular phenotype at birth, or whether they develop any differences over the first three months of life and whether this varies with other perinatal factors. This study also allows investigation of the short term impact of perinatal interventions used in this cohort. Comprehensive multi-modality non-invasive imaging measures of cardiovascular structure and function allow precise quantification of cardiovascular phenotype in this population.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Normotensive Term
Infants born at term (\>37 weeks) to Normotensive pregnancies
No interventions assigned to this group
Term Preeclampsia
Infants born at term (\>37 weeks gestation) and exposed to a preeclamptic pregnancy
No interventions assigned to this group
Preterm Normotensive
Infants born to Normotensive pregnancies at \<37 weeks gestation
No interventions assigned to this group
Preterm Hypertensive
Infants born to hypertensive pregnancies at \<37 weeks completed gestation
No interventions assigned to this group
Term Pregnancy-induced Hypertension
Infants born at term (\>37 weeks gestation) and exposed to pregnancy-induced hypertension
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Parent is willing and able to give informed consent for participation in the study,
* Physical condition is suitable to allow non-invasive vascular testing,
* Mother meets criteria for inclusion in the study and is willing to participate in the study. (Aged \>/= 16 years and Is able and willing to give informed consent for participation in the study, and is able and willing to give informed consent for her infants participation in the study. )
* Cases: Diagnosed during pregnancy with preeclampsia or gestational hypertension and/or delivered preterm (\<37 weeks gestation)
* Controls: No history of gestational hypertension or preeclampsia during this pregnancy and delivered at term (\>37 weeks gestation)
Exclusion Criteria
* Unavailable for assessment of cardiovascular system,
* Physical condition unsuitable to allow for non-invasive testing of cardiovascular system,
* Evidence of congenital cardiovascular disease (with the exception of Persistent Patent Ductus Arterious (PDA) and Atrial Septal Defect (ASD)),
* Cardiorespiratory instability at time of proposed measures,
* Active infection at time of proposed study measures,
* Mother of infant is excluded from the study. (Aged \<16 years, unable or unwilling to consent to study or Physical condition post delivery such that it would preclude participation in the study)
6 Months
ALL
No
Sponsors
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British Heart Foundation
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Paul Leeson, PhD, FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Oxford Department of Cardiovascular Medicine
Locations
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Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
Oxford, Oxfordshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EPOCH
Identifier Type: -
Identifier Source: org_study_id
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