FertilityNCT00390754
Usefulness of Home Pregnancy Testing
A study testing Education for pregnancy planning in people with Fertility, run by Michigan State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Education for pregnancy planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- fails to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
Official title: Utility of Home Pregnancy Testing in Medicaid Women at Risk for Unintended Pregnancy
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.
Read the 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
- Conditions
- Fertility
- Being tested
- Education for pregnancy planning
- Keywords
- pregnancy, unintended, menses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education for pregnancy planningBehavioural
Also called Home pregnancy testing
Provision of free home pregnancy tests to women at risk for unintended pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy Test Group | Experimental | Group got free home pregnancy test kits Receives: Behavioral: Education for pregnancy planning |
| 2 | No intervention | Group did not receive free home pregnancy test kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of use of home pregnancy test kits
Measured: 6 month followup
Secondary outcomes (2)
Knowledge about use of home pregnancy test kits
Measured: 6 months
Episodes of pregnancy suspicion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Community Health
- Investigators
- Mary D. Nettleman, MD, MS, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390754
- Sponsor's protocol ID
- 95530-00
- Status last verified
- Jul 2008
- First submitted
- 19 Oct 2006
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19062238
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Home Pregnancy Testing in Medicaid Women at Risk for Unintended Pregnancy
- ClinicalTrials.gov ID
- NCT00390754
- Acronym / sponsor ID
- 95530-00
- Conditions
- Fertility
- Keywords
- pregnancy, unintended, menses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Michigan Department of Community Health
- Study start
- Oct 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnancy Test Group | Experimental | Behavioral: Education for pregnancy planningGroup got free home pregnancy test kits |
| 2 | No intervention | –Group did not receive free home pregnancy test kits |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- aged 18 to 34 year old female,
- sexually active,
- not pregnant,
- not desiring pregnancy,
- not surgically sterile,
Key exclusion criteria (1 listed)
- fails to meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education for pregnancy planningAlso: Home pregnancy testingProvision of free home pregnancy tests to women at risk for unintended pregnancy | Behavioural | Pregnancy Test Group |
Primary outcome
Number of episodes of use of home pregnancy test kits
Time frame: 6 month followup
2 secondary outcomes
Knowledge about use of home pregnancy test kits
Time frame: 6 months
Episodes of pregnancy suspicion
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2008.
- Derived from this study: PubMed 19062238Nettleman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary D. Nettleman, MD, MS principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education for pregnancy planning in people with Fertility, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episodes of use of home pregnancy test kits (time frame: 6 month followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00390754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2008.