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Nurse Family Partnership (NFP) Contraceptive Study (NFP2)

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ClinicalTrials.gov Identifier: NCT00928538
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : March 30, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pregnancy Effective Contraceptive Use Family Planning Other: Enhanced NFP Care Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 344 participants
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
Study Start Date : September 2009
Primary Completion Date : May 2013
Study Completion Date : May 2015
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Unintended pregnancy [ Time Frame: Every three months after delivery for two years ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: June 26, 2009    Key Record Dates
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