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Preconception Women's Health in Pediatric Practice Intervention

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ClinicalTrials.gov Identifier: NCT02049554
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : August 22, 2017
Sponsor:
Collaborators:
Zanvyl and Isabelle Krieger Fund
Abell Foundation
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Preconception Care Women's Health Other: Preconception Care Screener Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Actual Study Start Date : October 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Experimental: Preconception Care Screener Group
Women's Health Screener and Clinician discussion
Other: Preconception Care Screener



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

Secondary Outcome Measures :
  1. Use of Highly Effective Contraception [ Time Frame: 6 months ]
  2. Use of Highly Effective Contraception [ Time Frame: 12 months ]
  3. Attendance at Preventive Health Care Visit [ Time Frame: 6 months ]
  4. Attendance at Preventive Health Care Visit [ Time Frame: 12 months ]


Information from the National Library of Medicine

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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:


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02049554     History of Changes
Other Study ID Numbers: NA_00084255
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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