NCT00390754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 29, 2008

Status Verified

July 1, 2008

Enrollment Period

11 months

First QC Date

October 19, 2006

Last Update Submit

July 25, 2008

Conditions

Fertility

Keywords

pregnancyunintendedmenses

Outcome Measures

Primary Outcomes (1)

  • Number of episodes of use of home pregnancy test kits

    6 month followup

Secondary Outcomes (2)

  • Knowledge about use of home pregnancy test kits

    6 months

  • Episodes of pregnancy suspicion

    6 months

Study Arms (2)

Pregnancy Test Group

EXPERIMENTAL

Group got free home pregnancy test kits

Behavioral: Education for pregnancy planning

2

NO INTERVENTION

Group did not receive free home pregnancy test kits

Interventions

Education for pregnancy planningBEHAVIORAL

Provision of free home pregnancy tests to women at risk for unintended pregnancy

Also known as: Home pregnancy testing
Pregnancy Test Group

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related Publications (1)

  • 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. doi: 10.1016/j.amepre.2008.09.023. Epub 2008 Dec 5.

    PMID: 19062238DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Mary D. Nettleman, MD, MS

    Michigan State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2006

First Posted

October 20, 2006

Study Start

October 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

July 29, 2008

Record last verified: 2008-07

Locations

US(1)