Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612320
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth Factors Associated with Refusal and Reasons for Refusal and Acceptance
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth Factors Associated with Refusal and Reasons for Refusal and Acceptance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFWIT
Brief Summary:
The main objective is to assess whether there are factors associated with womens refusal to participate in a randomized clinical trial involving pregnancy and childbirth in France The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate
Detailed Description:
1 Determine the acceptancerefusal rate among all women identified eligible and offered RCT
2 Comparison of demographic characteristics between the two groups
Group 1 women accepting to participate in RCT
Group 2 women refusing to participate in RCT
3 Assessment of motivations for acceptance based on questionnaire given to women who agree to participate
4 Evaluation of reasons for refusal to participate - obstacles based on the questionnaire given to women who refuse to participate
2 Comparison of demographic characteristics between the two groups
Group 1 women accepting to participate in RCT
Group 2 women refusing to participate in RCT
3 Assessment of motivations for acceptance based on questionnaire given to women who agree to participate
4 Evaluation of reasons for refusal to participate - obstacles based on the questionnaire given to women who refuse to participate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None