Comparison of Patients' Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia

Analgesia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325475
• Other study ID #: B.30.2.ATA.0.01.00/530
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: August 26, 2024

Study information

• Verified date: March 2024
• Source: Ataturk University
• Contact: Aysenur Dostbil
• Phone: +905333677796
• Email: adostbil[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 0.0625% 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 26, 2024
• Est. primary completion date: July 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Being =18 years old

• Pregnant women consenting to neuraxial analgesia for labor

• Being =37 weeks gestation

Exclusion Criteria:

• Patients in whom neuraxial analgesia is contraindicated

• Being <18 years old

• Being <37 weeks gestation

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• labor with neuraxial labor analgesia
Pregnant women in Group A will receive neuraxial labor analgesia (dural puncture epidural or combined spino epidural analgesia). If postpartum analgesic needs arise, patients in Group A will receive 0.0625% bupivacaine via epidural route.
• labour without noroaxial labor analgesia
Pregnant women in Group B will not receive neuraxial labor analgesia (dural puncture epidural or combined spino epidural analgesia). If postpartum analgesic needs arise, patients in Group B will receive iboprufen and acetaminophen.

Locations

Country	Name	City	State
Turkey	Atatürk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31. — View Citation

Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ObsQoR-10 scores of postpartum patients	ObsQoR-10 scores of postpartum patients will be recorded before discharge	Patients' ObsQoR-10 scores will be determined at 24 hours postpartum