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Nurse Family Partnership (NFP) Contraceptive Study (NFP2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00928538
First Posted: June 26, 2009
Last Update Posted: March 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Colorado, Denver
Clark County Department of Public Health
Thurston County Department of Public Health and Social Services
Public Health - Seattle and King County
Information provided by (Responsible Party):
Alan Melnick, Oregon Health and Science University
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Home Based Distribution of Hormonal Contraceptives for Women at Risk for Unintended Pregnancy

Further study details as provided by Alan Melnick, 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 ]

Secondary Outcome Measures:
  • Unintended pregnancy [ Time Frame: Every three months after delivery for two years ]

Enrollment: 344
Study Start Date: September 2009
Study Completion Date: May 2015
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.
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928538


Locations
United States, Washington
Thurston County Public Health
Olympia, Washington, United States, 98506
Seattle - King County Public Health
Seattle, Washington, United States
Clark County Public Health
Vancouver, Washington, United States, 98666
Sponsors and Collaborators
Oregon Health and Science University
University of Colorado, Denver
Clark County Department of Public Health
Thurston County Department of Public Health and Social Services
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, Adjunct Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00928538     History of Changes
Other Study ID Numbers: 832
First Submitted: June 25, 2009
First Posted: June 26, 2009
Last Update Posted: March 30, 2016
Last Verified: March 2016

Keywords provided by Alan Melnick, 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