This page gives you important information about the study. It describes the purpose of the research study, the risks, and possible benefits of participating. If there is anything in this form you do not understand, please contact the study team. Participation is voluntary and you may exit the survey at any time without penalty.
Why are you being asked to take part in this study?
You are being asked to take part in this research study because you are a clinician, administrator, or staff member involved in labor and delivery operations at a clinical site that uses or is considering using outpatient cervical ripening with a cervical ripening balloon (CRB).
What is the purpose of this research study?
The purpose of this study is to understand how clinical sites across the United States are implementing outpatient cervical ripening using a CRB. We aim to learn about site-level workflows, staffing models, eligibility criteria, patient communication strategies, and implementation approaches.
How many people will take part?
We anticipate responses from approximately 100 to 200 participants from labor and delivery units across the country.
How long will you be in this study?
If you agree to take part, the survey should take approximately 15-30 minutes to complete. There are no additional follow-ups unless you choose to provide your contact information for possible future participation.
What are the study procedures?
The study involves one survey. You will be asked a series of questions about how your institution implements outpatient cervical ripening with CRB. At the end of the survey, you may voluntarily provide your name and email address if you are open to being contacted for future research opportunities (e.g., interviews or focus groups).
What are the risks of this study?
Taking part in a research study involves inconveniences and risks. The main risk of this study is a potential loss of confidentiality. While you are asked to name your institution and may optionally provide your name and email address, your responses will be stored in REDCap, a secure, password-protected database. All data will be reported in aggregate, and individuals or institutions will not be identified in any publications or presentations.
Are there any benefits to taking part in this study?
There will be no direct benefit to you from taking part in this study. The knowledge gained may help inform best practices and guide future implementation of outpatient cervical ripening programs nationwide.
Do you need to give your consent in order to participate?
Yes. If you agree to participate, please indicate your consent by checking the agreement box and continuing to the survey. Participation is voluntary.
What happens if you decide not to take part in this study?
Participation is entirely voluntary. You may decline to participate or exit the survey at any time without penalty or loss of benefits.
Can you stop your participation in the study early?
Yes. You can stop taking the survey at any time without giving a reason. Partial responses will not be included unless consent is clearly provided.
What information about me may be collected, used or shared with others?
The name of your institution will be collected. You may also optionally provide your name and email address at the end of the survey if you wish to be contacted for future research opportunities (e.g., interviews or focus groups). No personal health information will be collected.
What about privacy and confidentiality?
All survey responses will be stored securely in REDCap, hosted by the University of Pennsylvania. Only the research team will have access to the data. Data will be de-identified before analysis and shared only in aggregate. Institutions and individuals will not be identified in any publications or presentations.
Will you be paid for taking part in this study?
No. There is no compensation for participating in this study.
What will happen to my information after the completion of this study?
De-identified survey data may be retained indefinitely for future research purposes. Contact information will only be used to recontact you if you have provided it voluntarily and will not be included in any shared datasets.
What if you have questions about the study?
If you have questions about the study, please contact Dr. Rebecca Hamm at Rebecca.Hamm@pennmedicine.upenn.edu or Dr. Susana Soto at Susana.Soto@pennmedicine.upenn.edu. If you have questions about your rights as a research participant, you may contact the University of Pennsylvania Institutional Review Board (IRB) at (215) 898-2614.