Preconception Women's Health in Pediatric Practice Intervention

August 21, 2017 updated by: Johns Hopkins University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

415

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Harriet Lane Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Usual Care
EXPERIMENTAL: Preconception Care Screener Group
Women's Health Screener and Clinician discussion
Other: Preconception Care Screener

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Receipt of preconception care
Time Frame: 6 months
6 months
Receipt of Preconception Care
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Use of Highly Effective Contraception
Time Frame: 6 months
6 months
Use of Highly Effective Contraception
Time Frame: 12 months
12 months
Attendance at Preventive Health Care Visit
Time Frame: 6 months
6 months
Attendance at Preventive Health Care Visit
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Zanvyl and Isabelle Krieger Fund
Abell Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2013

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (ESTIMATE)

January 30, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NA_00084255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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