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Providing Birth Control Through Home Health Visits

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ClinicalTrials.gov Identifier: NCT00065078
Recruitment Status : Unknown
Verified September 2005 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Active, not recruiting
First Posted : July 18, 2003
Last Update Posted : September 13, 2005
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
This study will evaluate a program that provides birth control to low income and minority women through home visits by a community health nurse. The goal of the program is to reduce unwanted pregnancies.

Condition or disease Intervention/treatment Phase
Pregnancy Procedure: Home dispensing of contraception Not Applicable

Detailed Description:

Unintended pregnancy is associated with significant public health problems, including inadequate prenatal care, low birth weight infants, infant mortality, and maternal morbidity and mortality. Children born as a result of unplanned pregnancies are at greater risk for poor outcomes such as poor mental health and developmental disabilities. This research project will determine whether providing contraception in the home can reduce the incidence of unintended pregnancy in low income and minority women. The project will also determine whether delaying a pelvic exam encourages or discourages the utilization of clinic-based preventive services to screen for sexually transmitted diseases (STDs) and cervical cancer.

Participants will be randomized to either an experimental group or a comparison group. Each participant will receive family planning counseling during a home visit by a community health nurse. Participants in the experimental group will be offered a three-month supply of oral contraceptives or a depo-provera shot; both forms of contraceptives will be delivered during home visits. Each participant will complete a survey during the initial visit and during a 1-year follow-up. The study will last approximately three years.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Nurse Home Contraceptive Dispensing
Study Start Date : June 2003
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control




Primary Outcome Measures :
  1. Pregnancy

Secondary Outcome Measures :
  1. Sexually Transmitted Disease Screening


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women of child bearing age
  • Not pregnant
  • Interested in delaying pregnancy using oral contraceptives or a depo-provera shot
  • Had sex in the last month or are planning to have sex in the next month
  • Have not used contraception during every sexual encounter within 3 months prior to study entry

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): NCT00065078


Locations
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United States, Oregon
Clackamas County Public Health Division
Oregon City, Oregon, United States, 97045
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Alan L Melnick, MD, MPH Oregon Health and Science University

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ClinicalTrials.gov Identifier: NCT00065078     History of Changes
Other Study ID Numbers: 5R01HD042423 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2003    Key Record Dates
Last Update Posted: September 13, 2005
Last Verified: September 2005

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Home-visits
Community nurse
Unintended pregnancy