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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02459990

Enrollment

22000

Registered

2015-06-02

Start date

2015-06-30

Completion date

2015-06-30

Last updated

2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension malformation fetal mortality

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

age and gender -

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Incident cases of Fetal Mortality among hypertensive women	up to 17 years	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)
Incident cases of Fetal Malformation among hypertensive women	up to 17 years	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)

Countries

United Kingdom

Outcome results