Manchester Antenatal Vascular Service

Completed

• Conditions: Vascular Disease
• Interventions: Other: no intervention

• Registration Number: NCT02244385
• Lead Sponsor: Manchester University NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 750

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation	no intervention	No intervention

Primary Outcome Measures

Name	Time	Method
Blood Pressure	At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Uteroplacental assessment	At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Vascular compliance	At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation

Trial Locations

Locations (1)

Maternal & Fetal Health Research Centre, 5th Floor St Mary's Hospital; 🇬🇧 Manchester, United Kingdom