Preconception Women's Health in Pediatric Practice Intervention

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02049554
• Collaborator: Zanvyl and Isabelle Krieger Fund (Other), Abell Foundation (Other)
• Enrollment: 415
• Location: 1
• Arms: 2
• Actual Duration (Months): 42
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 415 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Actual Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Receipt of preconception care [6 months]

2. Receipt of Preconception Care [12 months]

Secondary Outcome Measures

1. Use of Highly Effective Contraception [6 months]

2. Use of Highly Effective Contraception [12 months]

3. Attendance at Preventive Health Care Visit [6 months]

4. Attendance at Preventive Health Care Visit [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 49 Years
• Sexes Eligible for Study: 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Harriet Lane Clinic	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• Zanvyl and Isabelle Krieger Fund
• Abell Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02049554
• Other Study ID Numbers: NA_00084255
• First Posted: Jan 30, 2014
• Last Update Posted: Aug 22, 2017
• Last Verified: Aug 1, 2017

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

Study Results

No Results Posted as of Aug 22, 2017