Participate While Pregnant Survey

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02699632
• Collaborator: (none)
• Enrollment: 360
• Location: 1
• Actual Duration (Months): 11
• Patients Per Site Per Month: 32.7

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Pregnancy

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 360 participants
• Observational Model: Ecologic or Community
• Time Perspective: Retrospective
• Official Title: Research Participation in the Pregnant Population: A Survey Study
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Outcome Measures

Primary Outcome Measures

1. Willingness to Participate in Research While Pregnant [Day 1]

   Survey question: What types of research would you be willing to participate in while you were pregnant?

Secondary Outcome Measures

1. Preferred Methods for Learning About a Research Study [Day 1]

   Survey respondents were asked how they would prefer to learn about a research study with several answers cited.

2. Comfort of Participating in Research While Pregnant [Day 1]

   Survey question: Would you feel comfortable participating in a research study while pregnant?

3. Concerns for Participating in Research While Pregnant [Day 1]

   Survey question: What concerns might make you hesitant to participate in a research study while pregnant?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Any individual may complete this survey.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center

Investigators

• Principal Investigator: Leanne M Redman, PhD, MS, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT02699632
• Other Study ID Numbers: PBRC 2015-068
• First Posted: Mar 4, 2016
• Last Update Posted: Sep 16, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Leanne Redman, Principal Investigator, Pennington Biomedical Research Center: Survey

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	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).
Period Title: Overall Study
STARTED	360
COMPLETED	358
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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.
Overall Participants	360
Age, Customized (Count of Participants)
18-20 years	3 0.8%
21-25 years	42 11.7%
26-30 years	123 34.2%
31-45 years	182 50.6%
>45 years	8 2.2%
Sex: Female, Male (Count of Participants)
Female	360 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	7 1.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	47 13.1%
White	286 79.4%
More than one race	10 2.8%
Unknown or Not Reported	10 2.8%
Region of Enrollment (Count of Participants)
United States	360 100%

Outcome Measures

1. Primary Outcome

Title	Willingness to Participate in Research While Pregnant
Description	Survey question: What types of research would you be willing to participate in while you were pregnant?
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

part 1 of question observational studies; part 2 of question retrospective studies; part 3 of question lifestyle interventions in pregnancy

Arm/Group Title	All Participants
Arm/Group Description	Respondents were asked what types of research they were willing to participate in during pregnancy
Measure Participants	358
Yes	319 88.6%
No	39 10.8%
Yes	288 80%
No	70 19.4%
Yes	308 85.6%
No	50 13.9%

2. Secondary Outcome

Title	Preferred Methods for Learning About a Research Study
Description	Survey respondents were asked how they would prefer to learn about a research study with several answers cited.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	Survey respondents were asked how they would prefer to learn about a research study
Measure Participants	358
In person by my health care provider	222 61.7%
in person by someone I didn't know	130 36.1%
Other	6 1.7%

3. Secondary Outcome

Title	Comfort of Participating in Research While Pregnant
Description	Survey question: Would you feel comfortable participating in a research study while pregnant?
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	Survey respondents were asked about their comfort and whether or not their physician needed to be involved.
Measure Participants	358
Yes- if my physician approved	222 61.7%
Other	136 37.8%

4. Secondary Outcome

Title	Concerns for Participating in Research While Pregnant
Description	Survey question: What concerns might make you hesitant to participate in a research study while pregnant?
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	Survey respondents were asked about their concerns and what could be done to help minimize those concerns.
Measure Participants	358
physician's approval would ease concerns	233 64.7%
other	125 34.7%

Adverse Events

Adverse Event Reporting Description	Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Arm/Group Title	All Participants
Arm/Group Description
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

Completeness checks were not used.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.