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NCT00065078 Clinical Trial

Providing Birth Control Through Home Health Visits

Pregnancy Clinical Trial

Official title:
Effectiveness of Nurse Home Contraceptive Dispensing

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00065078
Other study ID # 5R01HD042423
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 16, 2003
Last updated September 9, 2005
Start date June 2003
Est. completion date July 2005

Study information
Verified date September 2005
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 600
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Home dispensing of contraception

Locations
Country Name City State
United States Clackamas County Public Health Division Oregon City Oregon

Sponsors (1)
Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy
Secondary Sexually Transmitted Disease Screening
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