Usefulness of Home Pregnancy Testing - Full Text View

Sponsors and Collaborators:	Michigan State University Michigan Department of Community Health
Information provided by:	Michigan State University
ClinicalTrials.gov Identifier:	NCT00390754

Purpose

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.

Condition	Intervention
Fertility	Behavioral: Education for pregnancy planning

MedlinePlus related topics: Medicaid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Utility of Home Pregnancy Testing in Medicaid Women at Risk for Unintended Pregnancy

Further study details as provided by Michigan State University:

Primary Outcome Measures:

Number of episodes of use of home pregnancy test kits [ Time Frame: 6 month followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knowledge about use of home pregnancy test kits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Episodes of pregnancy suspicion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	198
Study Start Date:	October 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pregnancy Test Group: Experimental Group got free home pregnancy test kits	Behavioral: Education for pregnancy planning Provision of free home pregnancy tests to women at risk for unintended pregnancy
2: No Intervention Group did not receive free home pregnancy test kits

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

Eligibility

Ages Eligible for Study:	18 Years to 34 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390754

Locations

United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824

Sponsors and Collaborators

Michigan State University

Michigan Department of Community Health

Investigators

Principal Investigator:

Mary D. Nettleman, MD, MS

Michigan State University

More Information

No publications provided by Michigan State University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Nettleman MD, Brewer JR, Ayoola AB. Self-testing for pregnancy among women at risk: a randomized controlled trial. Am J Prev Med. 2009 Feb;36(2):150-3. Epub 2008 Dec 5.

Responsible Party:	Michigan State University ( Mary Nettleman, MD, MS )
Study ID Numbers:	95530-00
Study First Received:	October 19, 2006
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00390754 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Michigan State University:

pregnancy
unintended
menses

Study placed in the following topic categories:

Infertility

ClinicalTrials.gov processed this record on May 07, 2009