Status:
UNKNOWN
The Effect of Prematurity and Hypertensive Disorders of Pregnancy on Offspring Cardiovascular Health
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
British Heart Foundation
Conditions:
Preeclampsia
Preterm Birth
Eligibility:
All Genders
Up to 6 years
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.
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 pre...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01888770
Start Date
August 1 2011
End Date
September 1 2017
Last Update
May 25 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 9DU