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Clinical Trials/NCT02049554
NCT02049554CompletedNot Applicable

Preconception Women's Health in Pediatric Practice Intervention

Johns Hopkins University2 sites in 1 country415 target enrollmentStarted: October 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
415
Locations
2
Primary Endpoint
Receipt of preconception care

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
15 Years to 49 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Receipt of preconception care

Time Frame: 6 months

Receipt of Preconception Care

Time Frame: 12 months

Secondary Outcomes

  • Attendance at Preventive Health Care Visit(12 months)
  • Use of Highly Effective Contraception(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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