Usefulness of Home Pregnancy Testing

Fertility Clinical Trial

Official title:

Utility of Home Pregnancy Testing in Medicaid Women at Risk for Unintended Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390754
• Other study ID #: 95530-00
• Status: Completed
• Phase: N/A
• First received: October 19, 2006
• Last updated: July 25, 2008
• Start date: October 2006
• Est. completion date: September 2007

Study information

• Verified date: July 2008
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Fertility

Intervention

Behavioral:
• Education for pregnancy planning
Provision of free home pregnancy tests to women at risk for unintended pregnancy

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	Michigan Department of Community Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of use of home pregnancy test kits		6 month followup	No
Secondary	Knowledge about use of home pregnancy test kits		6 months	No
Secondary	Episodes of pregnancy suspicion		6 months	No