- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00390754
Usefulness of Home Pregnancy Testing
July 25, 2008 updated by: Michigan State University
Utility of Home Pregnancy Testing in Medicaid Women at Risk for Unintended Pregnancy
The objective of this study is to determine whether women in a Medicaid population at risk for unintended pregnancy will keep a home pregnancy test on hand and (if necessary) use it appropriately.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Once pregnancy is recognized, most women seek prompt prenatal care and try to stop risk behaviors.
Unfortunately, women with unintended pregnancies do not recognize their pregnancies promptly, and inadvertently continue risk behaviors into the vulnerable early pregnancy weeks.
Home pregnancy testing is a rapid and inexpensive means of pregnancy diagnosis.
The objective of this study is to determine whether women in a Medicaid population at risk for unintended pregnancy will keep a home pregnancy test on hand and (if necessary) use it appropriately
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
East Lansing, Michigan, United States, 48824
- Michigan State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 34 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- aged 18 to 34 year old female,
- sexually active,
- not pregnant,
- not desiring pregnancy,
- not surgically sterile,
- intercourse at least once in the past 6 months without using effective contraception (hormonal or barrier or male vasectomy)
- receiving Medicaid OR child on Medicaid OR Medicaid paid for prev. preg
- understands written/spoken English enough to give informed consent and respond to survey
Exclusion Criteria:
- fails to meet inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pregnancy Test Group
Group got free home pregnancy test kits
|
Provision of free home pregnancy tests to women at risk for unintended pregnancy
Other Names:
|
|
No Intervention: 2
Group did not receive free home pregnancy test kits
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of episodes of use of home pregnancy test kits
Time Frame: 6 month followup
|
6 month followup
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Knowledge about use of home pregnancy test kits
Time Frame: 6 months
|
6 months
|
|
Episodes of pregnancy suspicion
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary D. Nettleman, MD, MS, Michigan State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
October 19, 2006
First Submitted That Met QC Criteria
October 19, 2006
First Posted (Estimate)
October 20, 2006
Study Record Updates
Last Update Posted (Estimate)
July 29, 2008
Last Update Submitted That Met QC Criteria
July 25, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 95530-00
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.