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Manchester Antenatal Vascular Service (MAViS)

NHS Foundation Trust logo

NHS Foundation Trust

Status

Completed

Conditions

Vascular Disease

Treatments

Other: no intervention

Study type

Observational

Funder types

Other

Identifiers

NCT02244385
11/NW/0426

Details and patient eligibility

About

25-30% of women with preexisting vascular disease (chronic hypertension/diabetes/obesity) will develop pre-eclampsia and or growth restriction. In addition, the frequency of stillbirths in this group is dramatically increased over the general population. Pregnancy complications in this very heterogeneous group are likely to be a combination of a failure of the maternal vasculature to adapt to pregnancy and/or a failure of placental development. The relative contribution of these two mechanisms is poorly understood and current preventative strategies (aspirin) in this group only prevent a small number of adverse outcomes. This important and complex group have been inadequately investigated to date mainly because of the diversity of their underlying disease complicating prospective research studies.

The evolution of tools which allow more detailed assessments of both uteroplacental blood flow and maternal vascular function will enable us to perform prospective studies in these women and to develop targeted preventative measures. Recent biomarker studies have also identified a number of biomarkers which have not yet been assessed in these high risk groups.

Enrollment

750 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

Women with preexisting vascular disease:

  1. chronic hypertension BP ≥140/90 at ≤14 weeks
  2. chronic hypertension requiring antihypertensive treatment ≤ 14 weeks
  3. pre gestational diabetes with evidence of vascular complications (hypertension, nephropathy)
  4. history of ischemic heart disease
  5. previous early onset pre-eclampsia (delivery < 32 weeks)
  6. Obesity (BMI ≥ 40) with any history of hypertension or booking BP≥130/80

Exclusion criteria

Women who do not meet the inclusion criteria

Trial design

750 participants in 1 patient group

Observation
Description:
No intervention
Treatment:
Other: no intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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