NCT02244385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

6 years

First QC Date

September 17, 2014

Last Update Submit

November 30, 2018

Conditions

Vascular Disease

Keywords

vascular diseasepregnancychronic hypertensiondiabetesobesity

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

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

Secondary Outcomes (2)

  • Vascular compliance

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

  • Uteroplacental assessment

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

Other Outcomes (2)

  • urinary albumin

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

  • Urinary podocyte markers

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

Study Arms (1)

Observation

No intervention

Other: no intervention

Interventions

no interventionOTHER
Observation

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women will be approached about the study in a dedicated clinic run within the Maternal \& Fetal Health Research Centre.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Manchester, M13 9WL, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood sample Urine sample

MeSH Terms

Conditions

Vascular DiseasesDiabetes MellitusObesity

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jenny Myers, PhD MRCOG BM BS

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 19, 2014

Study Start

July 1, 2011

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

December 4, 2018

Record last verified: 2018-11

Locations

GB(1)