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Nurse Family Partnership (NFP) Contraceptive Study (NFP2)

This study is currently recruiting participants.
Verified August 2011 by Oregon Health and Science University
Sponsor:
Collaborators:
University of Colorado, Denver
Public Health - Clark County
Pulbic Health - Thurston County
Public Health - Seattle and King County
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00928538
First received: June 25, 2009
Last updated: August 10, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to determine whether nurses can help at-risk women reduce the incidence of unintended pregnancy by providing them access to hormonal contraceptives in their homes.


Condition Intervention Phase
Pregnancy
Effective Contraceptive Use
Family Planning
 Other: Enhanced NFP Care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Home Based Distribution of Hormonal Contraceptives for Women at Risk for Unintended Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • One month gaps in effective contraceptive use (defined as methods with which < 10% of women experience an accidental pregnancy during a year of typical use) [ Time Frame: Every three months after delivery for two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unintended pregnancy [ Time Frame: Every three months after delivery for two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual NFP Care
Usual NFP care includes pregnancy planning and contraceptive advice during nurse home visits, with the prescription and dispensing of contraceptives provided through the women's primary care settings.
 Other: Enhanced NFP Care
Usual NFP care plus the enhanced care that includes contraceptive administration and distribution during nurse home visits. Participants will have a choice of combined hormonal contraception (oral, patches or vaginal rings)or progestin-only contraception (oral or depomedroxyprogesterone acetate injections.
Experimental: Enhanced NFP Care
Enhanced NFP intervention includes usual NFP care plus the intervention that includes contraceptive administration and distribution in the home
 Other: Enhanced NFP Care
Usual NFP care plus the enhanced care that includes contraceptive administration and distribution during nurse home visits. Participants will have a choice of combined hormonal contraception (oral, patches or vaginal rings)or progestin-only contraception (oral or depomedroxyprogesterone acetate injections.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English or Spanish speaking (or both)
  • Enrolled in the NFP (Nurse Family Partnership) program
  • 32 weeks or less gestation.

Exclusion Criteria:

  • Not enrolled in the NFP program
  • More than 32 weeks gestation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928538

Contacts
Contact: Rebecca Rdesinski, MSW, MPH 503-494-8375 rdesinsk@ohsu.edu
Contact: Elizabeth Jacob-Files, MA 503-494-2136 jacobfil@@ohsu.edu

Locations
United States, Washington
Thurston County Public Health Recruiting
Olympia, Washington, United States, 98506
Seattle - King County Public Health Recruiting
Seattle, Washington, United States
Clark County Public Health Recruiting
Vancouver, Washington, United States, 98666
Sponsors and Collaborators
Oregon Health and Science University
University of Colorado, Denver
Public Health - Clark County
Pulbic Health - Thurston County
Public Health - Seattle and King County
Investigators
Principal Investigator: Alan L Melnick, MD, MPH Oregon Health and Science University
  More Information

Publications:

Responsible Party: Alan Melnick, MD, MPH, CPH, Associate Professor, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00928538     History of Changes
Other Study ID Numbers: 832
Study First Received: June 25, 2009
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Female Contraception
Home Visits
CONTRACEPTIVE AGENTS
CONTRACEPTIVE DEVICES

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013