Overview

This trial is active, not recruiting.

Conditions preconception care, women's health
Treatment preconception care screener
Sponsor Johns Hopkins University
Collaborator Zanvyl and Isabelle Krieger Fund
Start date October 2013
End date March 2015
Trial size 415 participants
Trial identifier NCT02049554, NA_00084255

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(No Intervention)
(Experimental)
Women's Health Screener and Clinician discussion
preconception care screener

Primary Outcomes

Measure
Receipt of preconception care
time frame: 6 months
Receipt of Preconception Care
time frame: 12 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 15 years up to 49 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Johns Hopkins University.