Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-03 @ 9:09 PM
Study NCT ID:
NCT01996592
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Persistent Pain After CS Delivery
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Novel Approach Using Pre-surgery Psychosocial State and Pain Trajectory Methods to Identify Patient Characteristics and Predict Patients at Risk for Persistent Pain After Cesarean Delivery
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many factors influence the development of persistent pain after CS (chronic pain) as well as post-partum depression. We are attempting to use trajectory pain methods in an attempt to identify those at risk for the development of persistent pain post delivery using a daily method of contact for the determination of pain scores. Assessments are also done evaluating satisfaction of pain management and maternal/infant bonding opportunities. Physical activity is monitored by subject's wearing a Fitbit with correlation being done with pain scores obtained over 60 days postop with eligible subjects..
Detailed Description:
Subjects are contacted on a daily basis after having a cesarean delivery to determine current pain, current pain unpleasantness, worst pain, worst pain unpleasantness, average pain, and average pain unpleaseantness. Preoperatively subjects complete a psycho-social/depressive screening questionnaire. Pain treatments/satisfaction assessments are captured for the first 24 hours. Mother/baby outcomes are also captured. Physical activity and pain scores are also correlated with the subject's wearing of a Fitbit physical activity bracelet with eligible subjects for 60 days post-delivery.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: