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Manchester Antenatal Vascular Service

Manchester Antenatal Vascular Service

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02244385
Acronym
MAViS
Enrollment
750
Registered
2014-09-19
Start date
2011-07-31
Completion date
2017-12-31
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Disease

Keywords

vascular disease, pregnancy, chronic hypertension, diabetes, obesity

Brief summary

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.

Interventions

OTHERno intervention

Sponsors

National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
Manchester University NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Blood PressureAt recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation

Secondary

MeasureTime frame
Vascular complianceAt recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Uteroplacental assessmentAt recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation

Other

MeasureTime frame
urinary albuminAt recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Urinary podocyte markersAt recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026