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Completed

NCT Number: NCT02244385

Manchester Antenatal Vascular Service

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.

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Key information

Conditions

Vascular Disease Body Weight Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Maternal & Fetal Health Research Centre, 5th Floor St Mary's Hospital

Manchester, M13 9WL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with preexisting vascular disease:

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

Exclusion criteria

Women who do not meet the inclusion criteria

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Blood Pressure

    Time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation

Secondary outcomes

  1. Vascular compliance

    Time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation

  2. Uteroplacental assessment

    Time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation

Other outcomes

  1. urinary albumin

    Time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation

  2. Urinary podocyte markers

    Time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Acronym: MAViS

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2014
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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