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Preconception Women's Health in Pediatric Practice Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02049554
First Posted: January 30, 2014
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Zanvyl and Isabelle Krieger Fund
Abell Foundation
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose

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.


Condition Intervention
Preconception Care Women's Health Other: Preconception Care Screener

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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Receipt of preconception care [ Time Frame: 6 months ]
  • Receipt of Preconception Care [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Use of Highly Effective Contraception [ Time Frame: 6 months ]
  • Use of Highly Effective Contraception [ Time Frame: 12 months ]
  • Attendance at Preventive Health Care Visit [ Time Frame: 6 months ]
  • Attendance at Preventive Health Care Visit [ Time Frame: 12 months ]

Enrollment: 415
Actual Study Start Date: October 2013
Study Completion Date: April 2017
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Experimental: Preconception Care Screener Group
Women's Health Screener and Clinician discussion
Other: Preconception Care Screener

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049554


Locations
United States, Maryland
Johns Hopkins Harriet Lane Clinic
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Zanvyl and Isabelle Krieger Fund
Abell Foundation
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02049554     History of Changes
Other Study ID Numbers: NA_00084255
First Submitted: January 24, 2014
First Posted: January 30, 2014
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
preconception care
women's health