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The main goal for this study is to assess concerns and barriers to research participation by pregnant women through an anonymous online survey (www.pbrc.edu/ParticipateWhilePregnantSurvey).
Participants will complete an online survey distributed through HIPAA compliant REDCap database. Collected data will consist of general multiple choice responses and optional "write-in" responses (e.g. providing a personal response for elaboration an "Other" option). No private health information will be collected.
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| Measure | Description | Time Frame |
|---|---|---|
| Willingness to Participate in Research While Pregnant | Survey question: What types of research would you be willing to participate in while you were pregnant? | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Preferred Methods for Learning About a Research Study | Survey respondents were asked how they would prefer to learn about a research study with several answers cited. | Day 1 |
| Comfort of Participating in Research While Pregnant |
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Inclusion Criteria:
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Subjects will be recruited online. Anyone can take this survey, however females who have been pregnant or are planning to become pregnant will be the most relevant population.
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| Name | Affiliation | Role |
|---|---|---|
| Leanne M Redman, PhD, MS | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28178062 | Derived | Sutton EF, Cain LE, Vallo PM, Redman LM. Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials. Obstet Gynecol. 2017 Mar;129(3):554-559. doi: 10.1097/AOG.0000000000001900. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | The survey was taken by 360 women previously, currently, or planning to become pregnant. Although number of unique site visitors between January and June 2016 is indeterminable, we had a completion rate of 69% (the percentage of surveys completed out of the total number initiated, ie, number of page 2 completions and number of page 1 completions). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Women previously, currently, or planning to become pregnant. Data utilized is from completed questionnaires only, is uncorrected, and was collected from January through June 2016. Mode of initial contact with potential participants was made on the Internet (email and Facebook posts). Participants were instructed of survey length in these Internet advertisements and study purpose and data storage information on the first page of our electronic survey. No incentives were offered to participants, no protected health information was collected, and no measures were used for prevention of multiple entries from the same individual. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Willingness to Participate in Research While Pregnant | Survey question: What types of research would you be willing to participate in while you were pregnant? | part 1 of question observational studies; part 2 of question retrospective studies; part 3 of question lifestyle interventions in pregnancy | Posted | Count of Participants | Participants | Day 1 |
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Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants |
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Completeness checks were not used.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leanne Redman, Principal Investigator | Pennington Biomedical Research Center | 2257630947 | Leanne.Redman@pbrc.edu |
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Survey question: Would you feel comfortable participating in a research study while pregnant?
| Day 1 |
| Concerns for Participating in Research While Pregnant | Survey question: What concerns might make you hesitant to participate in a research study while pregnant? | Day 1 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Secondary | Preferred Methods for Learning About a Research Study | Survey respondents were asked how they would prefer to learn about a research study with several answers cited. | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Comfort of Participating in Research While Pregnant | Survey question: Would you feel comfortable participating in a research study while pregnant? | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Concerns for Participating in Research While Pregnant | Survey question: What concerns might make you hesitant to participate in a research study while pregnant? | Posted | Count of Participants | Participants | Day 1 |
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| 0 |
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