NCT02049554

Brief Summary

The aims of the intervention are:

  1. 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. 2.Assess the cost-effectiveness of preconception health care initiated in pediatric practices.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

January 24, 2014

Last Update Submit

August 21, 2017

Conditions

Preconception CareWomen's Health

Keywords

preconception carewomen's health

Outcome Measures

Primary Outcomes (2)

  • Receipt of preconception care

    6 months

  • Receipt of Preconception Care

    12 months

Secondary Outcomes (4)

  • Use of Highly Effective Contraception

    6 months

  • Use of Highly Effective Contraception

    12 months

  • Attendance at Preventive Health Care Visit

    6 months

  • Attendance at Preventive Health Care Visit

    12 months

Study Arms (2)

Usual Care

NO INTERVENTION

Preconception Care Screener Group

EXPERIMENTAL

Women's Health Screener and Clinician discussion

Other: Preconception Care Screener

Interventions

Preconception Care ScreenerOTHER
Preconception Care Screener Group

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Harriet Lane Clinic

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Chilukuri N, Cheng TL, Psoter KJ, Mistry KB, Connor KA, Levy DJ, Upadhya KK. Effectiveness of a Pediatric Primary Care Intervention to Increase Maternal Folate Use: Results from a Cluster Randomized Controlled Trial. J Pediatr. 2018 Jan;192:247-252.e1. doi: 10.1016/j.jpeds.2017.09.020.

    PMID: 29246348DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 30, 2014

Study Start

October 1, 2013

Primary Completion

March 1, 2015

Study Completion

April 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

US(1)