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Usefulness of Home Pregnancy Testing

This study has been completed.
Sponsor:
Collaborator:
Michigan Department of Community Health
Information provided by:
Michigan State University
ClinicalTrials.gov Identifier:
NCT00390754
First received: October 19, 2006
Last updated: July 25, 2008
Last verified: July 2008
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Utility of Home Pregnancy Testing in Medicaid Women at Risk for Unintended Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Infertility Medicaid
U.S. FDA Resources

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
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

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 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
Study First Received: October 19, 2006
Last Updated: July 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
pregnancy
unintended
menses

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013