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NCT02049554 Clinical Trial

Preconception Women's Health in Pediatric Practice Intervention

Women's Health Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02049554
Other study ID # NA_00084255
Secondary ID
Status Completed
Phase N/A
First received January 24, 2014
Last updated August 21, 2017
Start date October 2013
Est. completion date April 2017

Study information
Verified date August 2017
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aims of the intervention are:

1. Assess the feasibility and effectiveness of preconception health care initiated by pediatric clinicians on outcomes including women's access to primary care and contraceptive services; contraception and rapid repeat pregnancy rate and interpregnancy interval; and women's immunization rate, control of chronic illnesses, nutritional status, smoking and substance use, mental health and violence exposure; child and family health.

2. Assess the cost-effectiveness of preconception health care initiated in pediatric practices.

The investigators will evaluate these outcomes with a clinic based trial comparing usual care to preconception care intervention.

Recruitment information / eligibility
Status Completed
Enrollment 415
Est. completion date April 2017
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 49 Years
Eligibility Inclusion Criteria:

Mothers with children ages 0 to 12 months presenting with their child for care at a participating pediatric office.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Preconception Care Screener

Locations
Country Name City State
United States Johns Hopkins Harriet Lane Clinic Baltimore Maryland

Sponsors (3)
Lead Sponsor Collaborator
Johns Hopkins University Abell Foundation, Zanvyl and Isabelle Krieger Fund

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Receipt of preconception care 6 months
Primary Receipt of Preconception Care 12 months
Secondary Use of Highly Effective Contraception 6 months
Secondary Use of Highly Effective Contraception 12 months
Secondary Attendance at Preventive Health Care Visit 6 months
Secondary Attendance at Preventive Health Care Visit 12 months
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