NCT02699632

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

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

January 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 19, 2018

Completed
Last Updated

September 16, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

January 21, 2016

Results QC Date

February 24, 2017

Last Update Submit

August 23, 2021

Conditions

Pregnancy

Keywords

Survey

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Preferred Methods for Learning About a Research Study

    Day 1

  • Comfort of Participating in Research While Pregnant

    Day 1

  • Concerns for Participating in Research While Pregnant

    Day 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Any individual may complete this survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • 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.

    PMID: 28178062DERIVED

Limitations and Caveats

Completeness checks were not used.

Results Point of Contact

Title
Leanne Redman, Principal Investigator
Organization
Pennington Biomedical Research Center
Leanne.Redman@pbrc.edu
2257630947

Study Officials

  • Leanne M Redman, PhD, MS

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2016

First Posted

March 4, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 16, 2021

Results First Posted

February 19, 2018

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)