PreeclampsiaEPOCHNCT01888770
The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
An observational study of Preeclampsia and Preterm Birth, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether exposure to hypertensive disorders of pregnancy and/or a preterm birth results in alterations in the cardiovascular system during infancy. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Preeclampsia, Preterm Birth
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Sep 2017
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Study population is drawn from infants admitted to or delivered in the OUH NHS Foundation trust to normotensive or hypertensive pregnancies across a range of gestations. The mothers of these infants form a secondary study cohort.
Who may be able to join
- Available for assessment within the neonatal period,
- 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)
Who cannot join
- Parent is unwilling to give consent,
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
Oxford, Oxfordshire, OX3 9DU
Paul Leeson, PhD, MRCP, paul.leeson@cardiov.ox.ac.uk
Paul Leeson, PhD, FRCP
About this study
The purpose of this study is to investigate whether exposure to hypertensive disorders of pregnancy and/or a preterm birth results in alterations in the cardiovascular system during infancy.
Read the detailed description
While the incidence of cardiovascular disease has reduced dramatically, coinciding with favourable changes in risk factors, cardiovascular disease remains the single largest cause of mortality and premature mortality in the United Kingdom. Identification of novel biological pathways that underlie disease susceptibility raises the potential for new early primary prevention strategies to complement classical management. There is particular interest in the role of early environment in 'programming' risk of cardiovascular disease in later life and growing evidence that various early life exposures impact cardiovascular health in the longer term.
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
- Preeclampsia, Preterm Birth
- Medical subject headings
- Pre-Eclampsia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normotensive Term | Infants born at term (>37 weeks) to Normotensive pregnancies | |
| Term Preeclampsia | Infants born at term (>37 weeks gestation) and exposed to a preeclamptic pregnancy | |
| Preterm Normotensive | Infants born to Normotensive pregnancies at <37 weeks gestation | |
| Preterm Hypertensive | Infants born to hypertensive pregnancies at <37 weeks completed gestation | |
| Term Pregnancy-induced Hypertension | Infants born at term (>37 weeks gestation) and exposed to pregnancy-induced hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Cardiac Function
Cardiac Function will be assessed by ECHO at birth and 3 months
Measured: Birth and 3 months
Secondary outcomes (6)
Micro-vascular Structure
Micro-vascular Structure will be assessed using Side Stream Dark Field (SDF) imaging device at birth and 3 months (as capillary density at baseline)
Measured: Birth and 3 months
Pulse wave velocity and pulse-wave analysis
Measured: Birth and 3 months
Cardiac Structure
Cardiac structure will be assessed by echocardiography at in utero, at birth and 3 months (as left and right ventricular mass)
Measured: Birth and 3 months
Cardiac diastolic function
Cardiac Function will be assessed by ECHO at birth and 3 months
Measured: Birth and 3 months
Blood pressure
Measured: Birth and 3 months
Heart rate variability
Heart rate variability will be assessed by a 5 minute electrocardiogram
Measured: Birth and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startAug 2011
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Paul Leeson, PhD, FRCP, Principal investigator, University of Oxford Department of Cardiovascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888770
- Sponsor's protocol ID
- EPOCH
- Acronym
- EPOCH
- Status last verified
- May 2016
- First submitted
- 13 Jun 2013
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
- ClinicalTrials.gov ID
- NCT01888770
- Acronym / sponsor ID
- EPOCH / EPOCH
- Conditions
- Preeclampsia, Preterm Birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Aug 2011
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 28 Jun 2013 (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.
The purpose of this study is to investigate whether exposure to hypertensive disorders of pregnancy and/or a preterm birth results in alterations in the cardiovascular system during infancy.
Detailed description
While the incidence of cardiovascular disease has reduced dramatically, coinciding with favourable changes in risk factors, cardiovascular disease remains the single largest cause of mortality and premature mortality in the United Kingdom. Identification of novel biological pathways that underlie disease susceptibility raises the potential for new early primary prevention strategies to complement classical management. There is particular interest in the role of early environment in 'programming' risk of cardiovascular disease in later life and growing evidence that various early life exposures impact cardiovascular health in the longer term.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normotensive Term | – | –Infants born at term (>37 weeks) to Normotensive pregnancies |
| Term Preeclampsia | – | –Infants born at term (>37 weeks gestation) and exposed to a preeclamptic pregnancy |
| Preterm Normotensive | – | –Infants born to Normotensive pregnancies at <37 weeks gestation |
| Preterm Hypertensive | – | –Infants born to hypertensive pregnancies at <37 weeks completed gestation |
| Term Pregnancy-induced Hypertension | – | –Infants born at term (>37 weeks gestation) and exposed to pregnancy-induced hypertension |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study population is drawn from infants admitted to or delivered in the OUH NHS Foundation trust to normotensive or hypertensive pregnancies across a range of gestations. The mothers of these infants form a secondary study cohort.
Key inclusion criteria (6 listed)
- Available for assessment within the neonatal period,
- 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)
Key exclusion criteria (7 listed)
- Parent is unwilling to give consent,
- 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,
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
Systolic Cardiac Function
Time frame: Birth and 3 months
Cardiac Function will be assessed by ECHO at birth and 3 months
6 secondary outcomes
Micro-vascular Structure
Time frame: Birth and 3 months
Pulse wave velocity and pulse-wave analysis
Time frame: Birth and 3 months
Cardiac Structure
Time frame: Birth and 3 months
Cardiac diastolic function
Time frame: Birth and 3 months
Blood pressure
Time frame: Birth and 3 months
Heart rate variability
Time frame: Birth and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
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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.
Paul Leeson, PhD, FRCP principal investigator
University of Oxford Department of Cardiovascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Preterm Birth, run by University of Oxford at 1 site in United Kingdom.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Leeson, PhD, FRCP (+44(0)1865572846, paul.leeson@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Cardiac Function (time frame: Birth and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2016.