NCT02459990

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

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

First Submitted

Initial submission to the registry

May 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

May 20, 2015

Last Update Submit

May 30, 2016

Conditions

Hypertension

Keywords

Hypertension malformation fetal mortality

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

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

Women who may become pregnant ages 18-50 in the UK.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

June 2, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

GB(1)