Trial record 2 of 4 for:    Open Studies | "Preconception Care"

Preconception Women's Health in Pediatric Practice Intervention

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Johns Hopkins University
Sponsor:
Collaborators:
Zanvyl and Isabel Krieger Fund
Abell Foundation
Aetna Foundation
Information provided by (Responsible Party):
Tina L. Cheng, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02049554
First received: January 24, 2014
Last updated: January 28, 2014
Last verified: January 2014
  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
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
  • Receipt of Preconception Care [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of Highly Effective Contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Use of Highly Effective Contraception [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Attendance at Preventive Health Care Visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Attendance at Preventive Health Care Visit [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: October 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Experimental: Preconception Care Screener Group Other: Preconception Care Screener

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049554

Contacts
Contact: Krishna Upadhya, MD, MPH kupadhy2@jhmi.edu

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

No publications provided

Responsible Party: Tina L. Cheng, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02049554     History of Changes
Other Study ID Numbers: NA_00084255
Study First Received: January 24, 2014
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014