Trial Outcomes & Findings for Participate While Pregnant Survey (NCT NCT02699632)

NCT ID: NCT02699632

Last Updated: 2021-09-16

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 360 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2021-09-16

Participant Flow

Participant milestones

Measure	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).
Overall Study STARTED	360
Overall Study COMPLETED	358
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participate While Pregnant Survey

Baseline characteristics by cohort

Measure	All Participants n=360 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.
Age, Customized 18-20 years	3 Participants n=5 Participants
Age, Customized 21-25 years	42 Participants n=5 Participants
Age, Customized 26-30 years	123 Participants n=5 Participants
Age, Customized 31-45 years	182 Participants n=5 Participants
Age, Customized >45 years	8 Participants n=5 Participants
Sex: Female, Male Female	360 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	47 Participants n=5 Participants
Race (NIH/OMB) White	286 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Region of Enrollment United States	360 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

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

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

Outcome measures

Measure	All Participants n=358 Participants Respondents were asked what types of research they were willing to participate in during pregnancy
Willingness to Participate in Research While Pregnant Observational Studies · Yes	319 Participants
Willingness to Participate in Research While Pregnant Observational Studies · No	39 Participants
Willingness to Participate in Research While Pregnant Retrospective Studies · Yes	288 Participants
Willingness to Participate in Research While Pregnant Retrospective Studies · No	70 Participants
Willingness to Participate in Research While Pregnant Lifestyle Interventions in Pregnancy · Yes	308 Participants
Willingness to Participate in Research While Pregnant Lifestyle Interventions in Pregnancy · No	50 Participants

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	All Participants n=358 Participants Respondents were asked what types of research they were willing to participate in during pregnancy
Preferred Methods for Learning About a Research Study In person by my health care provider	222 Participants
Preferred Methods for Learning About a Research Study in person by someone I didn't know	130 Participants
Preferred Methods for Learning About a Research Study Other	6 Participants

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	All Participants n=358 Participants Respondents were asked what types of research they were willing to participate in during pregnancy
Comfort of Participating in Research While Pregnant Yes- if my physician approved	222 Participants
Comfort of Participating in Research While Pregnant Other	136 Participants

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	All Participants n=358 Participants Respondents were asked what types of research they were willing to participate in during pregnancy
Concerns for Participating in Research While Pregnant physician's approval would ease concerns	233 Participants
Concerns for Participating in Research While Pregnant other	125 Participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leanne Redman, Principal Investigator

Pennington Biomedical Research Center

Phone: 2257630947

Email: Leanne.Redman@pbrc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place