Manchester Antenatal Vascular Service

Vascular Disease Clinical Trial

— MAViS  

Official title:

Manchester Antenatal Vascular Service

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244385
• Other study ID #: 11/NW/0426
• Status: Completed
• Start date: July 2011
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Disease
• Vascular Diseases

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
United Kingdom	Maternal & Fetal Health Research Centre, 5th Floor St Mary's Hospital	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	urinary albumin		At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Other	Urinary podocyte markers		At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Primary	Blood Pressure		At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Secondary	Vascular compliance		At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Secondary	Uteroplacental assessment		At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation