Clinical trial NCT02244385: Manchester Antenatal Vascular Service
Official title: Manchester Antenatal Vascular Service
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Disease
Keywords: vascular disease
pregnancy
chronic hypertension
diabetes
obesity
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2014-09-19
Enrollment: 750
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women will be approached about the study in a dedicated clinic run within the Maternal \& Fetal Health Research Centre.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure
timeFrame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Secondary outcomes:
measure: Vascular compliance
timeFrame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
measure: Uteroplacental assessment
timeFrame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Other outcomes:
measure: urinary albumin
timeFrame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
measure: Urinary podocyte markers
timeFrame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Locations:
city: Manchester
country: United Kingdom
facility: Maternal & Fetal Health Research Centre, 5th Floor St Mary's Hospital
Study officials:
affiliation: University of Manchester
name: Jenny Myers, PhD MRCOG BM BS
role: PRINCIPAL_INVESTIGATOR
References: