Manchester Antenatal Vascular Service

NCT ID: NCT02244385

Last Updated: 2018-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Vascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation

No intervention

no intervention

Intervention Type OTHER

Interventions

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no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jenny Myers, PhD MRCOG BM BS

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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11/NW/0426

Identifier Type: -

Identifier Source: org_study_id

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