ClinicalTrials.gov
ClinicalTrials.gov Menu

Usefulness of Home Pregnancy Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00390754
Recruitment Status : Completed
First Posted : October 20, 2006
Last Update Posted : July 29, 2008
Sponsor:
Collaborator:
Michigan Department of Community Health
Information provided by:
Michigan State University

Brief Summary:
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 or disease Intervention/treatment Phase
Fertility Behavioral: Education for pregnancy planning Not Applicable

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  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Utility of Home Pregnancy Testing in Medicaid Women at Risk for Unintended Pregnancy
Study Start Date : October 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicaid
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pregnancy Test Group
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
Other Name: Home pregnancy testing
No Intervention: 2
Group did not receive free home pregnancy test kits



Primary Outcome Measures :
  1. Number of episodes of use of home pregnancy test kits [ Time Frame: 6 month followup ]

Secondary Outcome Measures :
  1. Knowledge about use of home pregnancy test kits [ Time Frame: 6 months ]
  2. Episodes of pregnancy suspicion [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes 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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Nettleman, MD, MS, Michigan State University
ClinicalTrials.gov Identifier: NCT00390754     History of Changes
Other Study ID Numbers: 95530-00
First Posted: October 20, 2006    Key Record Dates
Last Update Posted: July 29, 2008
Last Verified: July 2008

Keywords provided by Michigan State University:
pregnancy
unintended
menses