Vascular DiseaseMAViSNCT02244385
Manchester Antenatal Vascular Service
An observational study of Vascular Disease, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vascular Disease
- How many people
- 750 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women will be approached about the study in a dedicated clinic run within the Maternal \& Fetal Health Research Centre.
Who may be able to join
- 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
Who cannot join
- Women who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Maternal & Fetal Health Research Centre, 5th Floor St Mary's Hospital
Manchester, M13 9WL
About this study
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.
- Conditions
- Vascular Disease
- Being tested
- no intervention
- Keywords
- vascular disease, pregnancy, chronic hypertension, diabetes, obesity
- Medical subject headings
- Vascular Diseases, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Secondary outcomes (2)
Vascular compliance
Measured: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Uteroplacental assessment
Measured: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startJul 2011
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Jenny Myers, PhD MRCOG BM BS, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244385
- Sponsor's protocol ID
- 11/NW/0426
- Acronym
- MAViS
- Status last verified
- Nov 2018
- First submitted
- 17 Sep 2014
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manchester Antenatal Vascular Service
- ClinicalTrials.gov ID
- NCT02244385
- Acronym / sponsor ID
- MAViS / 11/NW/0426
- Conditions
- Vascular Disease
- Keywords
- vascular disease, pregnancy, chronic hypertension, diabetes, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Jul 2011
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Other: no interventionNo intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women will be approached about the study in a dedicated clinic run within the Maternal \& Fetal Health Research Centre.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- Women who do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | Observation |
Primary outcome
Blood Pressure
Time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
2 secondary outcomes
Vascular compliance
Time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Uteroplacental assessment
Time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Myers, PhD MRCOG BM BS principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Disease, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.