Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325475
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-16
Brief Title:
Comparison of Patients Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
Comparison of Patients Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia A Single-center Observational Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The aim of this study was to compare the postpartum recovery of pregnant women who had vaginal delivery with and without neuraxial labor analgesia using the ObsQoR-10 scoring system
Detailed Description:
In this study we planned to conduct a study to compare the postpartum recovery of pregnant women according to patient-reported outcome measures using the ObsQoR-10 score in vaginal deliveries with and without neuraxial labor analgesia dural puncture epidural or combined spino epidural analgesia
In this study after obtaining the approval of the ethics committee of Atatürk University Faculty of Medicine Hospital and written informed consent of the patients 40 pregnant women who will deliver vaginally with or without neuraxial analgesia will be prospectively enrolled
Patients will be randomized by a statistician using a computerized random numbers table and divided into 2 equal groups as Group A and Group B Pregnant women in Group A will receive neuraxial labor analgesia dural puncture epidural or combined spino epidural analgesia while Group B will not If postpartum analgesic needs arise patients in Group A will receive 00625 bupivacaine via epidural route while pregnant women in Group B will receive iboprufen and acetaminophen if needed
ObsQoR-10 scores of the postpartum patients will be evaluated and recorded at discharge In addition basic demographic information and medical analgesic and obstetric parameters related to the peripartum period will be recorded
In this study after obtaining the approval of the ethics committee of Atatürk University Faculty of Medicine Hospital and written informed consent of the patients 40 pregnant women who will deliver vaginally with or without neuraxial analgesia will be prospectively enrolled
Patients will be randomized by a statistician using a computerized random numbers table and divided into 2 equal groups as Group A and Group B Pregnant women in Group A will receive neuraxial labor analgesia dural puncture epidural or combined spino epidural analgesia while Group B will not If postpartum analgesic needs arise patients in Group A will receive 00625 bupivacaine via epidural route while pregnant women in Group B will receive iboprufen and acetaminophen if needed
ObsQoR-10 scores of the postpartum patients will be evaluated and recorded at discharge In addition basic demographic information and medical analgesic and obstetric parameters related to the peripartum period will be recorded
Study Oversight
Has Oversight DMC:
None
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?:
None