- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00065078
Providing Birth Control Through Home Health Visits
Effectiveness of Nurse Home Contraceptive Dispensing
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Oregon City, Oregon, United States, 97045
- Clackamas County Public Health Division
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control Group
The control group receives only Family Planning Counseling.
|
Family Planning Counseling
|
|
Experimental: Intervention Group
The intervention group receives Family Planning Counseling and contraception in the home.
|
Family Planning Counseling
Home dispensing of contraception
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pregnancy
Time Frame: Twelve month follow-up (June 2004 - July 2025)
|
Twelve month follow-up (June 2004 - July 2025)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sexually Transmitted Disease Screening
Time Frame: Twelve month follow-up (June 2004 - July 2025)
|
Twelve month follow-up (June 2004 - July 2025)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alan L Melnick, MD, MPH, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00002668
- 5R01HD042423 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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