NCT03411993

Brief Summary

There is currently no routine screening for cardiac disease for pregnant women in areas of high prevalence. This study will aim to determine the point prevalence of cardiac disease in women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically, it will aim to use focused echocardiography as a screening tool to determine the prevalence of cardiac disease among pregnant women attending MTRH antenatal clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
612

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

1 month

First QC Date

January 17, 2018

Last Update Submit

July 26, 2018

Conditions

Cardiac DiseasePregnancy Related

Outcome Measures

Primary Outcomes (1)

  • Cardiac disease

    Point prevalence of cardiac lesions identifiable by cardiac echo

    through study completion, an average of 3 months

Interventions

Focused cardiac echographyDIAGNOSTIC_TEST

All pregnant women attending antenatal care will be eligible to undergo focused cardiac echo to identify underlying cardiac disease

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All pregnant women attending the antenatal clinic at Moi Teaching and Referral Hospital. This clinic serves approximately 750 women per month. These women draw from urban, peri-urban and rural areas. As this is a public hospital, income and education levels are low.

You may qualify if:

  • pregnant women at any gestational age
  • capable to give informed consent

You may not qualify if:

  • medically unstable: any condition or complication resulting from or independent of pregnancy that necessitates urgent care or that precludes full and informed consent process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, 30100, Kenya

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • John Snelgrove, MD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Lecturer

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 26, 2018

Study Start

January 31, 2018

Primary Completion

March 12, 2018

Study Completion

March 12, 2018

Last Updated

July 27, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)