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NCT02459990 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02459990
Other study ID # D2452R00003
Secondary ID
Status Completed
Phase N/A
First received May 20, 2015
Last updated May 30, 2016
Start date June 2015
Est. completion date June 2015

Study information
Verified date May 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kingdom: MHRA The Clinical Practice Research Datalink (CPRD) ISAC
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 22000
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: age and gender -

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Research Site London

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incident cases of Fetal Mortality among hypertensive women Number of incident Fetal mortality cases among hypertensive women, study period duration is 204 months (start date 1997 to end of follow-up date 2014) up to 17 years Yes
Primary Incident cases of Fetal Malformation among hypertensive women Number of incident Fetal Malformation cases among hypertensive women, study period duration is 204 months (start date 1997 to end of follow-up date 2014) up to 17 years Yes
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