Congenital Malformations and Maternal Use of Anti-hypertensive Medication in the United Kingdom

NCT ID: NCT02459990

Last Updated: 2016-06-01

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

22000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-06-30

Brief Summary

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Assess Fetal Mortality and Malformations in Women treated with antihypertensive medication during preganancy. Mother - Child pairs will be analysed in a cohort selected from the UK in the CPRD database. Years covered are 1997 to 2014. Aim is to assess the risk of Antihypertensive treatment in women.

Detailed Description

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Women with chronic hypertension are at risk of experiencing severe complications such as adverse effects of fetal growth, survival, and renal function during pregnancy. General recommendations advocate the treatment of high blood pressure during pregnancy to decrease these risks to the mother and child, with extreme caution. Many studies assessing the risk of congenital malformations in infants whose mothers were treated with anti-hypertensive medication have been inconclusive, in part due to the variability of the original data sources and possibly the robustness of the analyses.2 Studies regarding this health issue have been unable to stratify anti-hypertensive medications sufficiently to truly assess the risk per drug class, Angiotensin II Receptor Antagonists/Blockers (ARBs) and Angiotensin-converting-enzyme inhibitor (ACE inhibitor) in particular.We will attempt to assess the prescription rate of ARBs and ACE inhibitors among women with very high blood pressure in the United Kingdom (UK) and estimate the risk of serious foetal outcomes in women treated with ARBs and/or ACEs and who may also have the following co-morbid conditions: Diabetes Types I or II, Diabetic Nephropathy, and Congestive Heart Failure.

Conditions

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Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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D2452R00003

Identifier Type: -

Identifier Source: org_study_id

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