The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health

NCT01888770 | Unknown

• 1 other identifier: EPOCH
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preeclampsia; Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Systolic Cardiac Function

  Cardiac Function will be assessed by ECHO at birth and 3 months

  Birth and 3 months

Secondary Outcomes (6)

• Micro-vascular Structure

  Birth and 3 months

• Pulse wave velocity and pulse-wave analysis

  Birth and 3 months

• Cardiac Structure

  Birth and 3 months

• Cardiac diastolic function

  Birth and 3 months

• Blood pressure

  Birth and 3 months

Study Arms (5)

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

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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,
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead
• British Heart Foundation: collaborator

Study Sites (1)

Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma

MeSH Terms

Conditions

Pre-Eclampsia; Premature Birth

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Paul Leeson, PhD, FRCP

  University of Oxford Department of Cardiovascular Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Leeson, PhD, FRCP

CONTACT

+44(0)1865572846; paul.leeson@cardiov.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 28, 2013
• Study Start: August 1, 2011
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

GB (1)