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

Not Applicable

Recruiting

• Conditions: Analgesia
• Interventions: Procedure: labor with neuraxial labor analgesia; Procedure: labour without noroaxial labor analgesia

• Registration Number: NCT06325475
• Lead Sponsor: Ataturk University

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 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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-16
• Study First Submitted QC: 2024-03-16
• Last Update Submitted: 2024-03-16
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Study Start: 2024-03-26
• Primary Completion: 2024-07-26
• Study Completion: 2024-08-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	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.
Group B	labour without noroaxial labor analgesia	Pregnant women in Group A will not receive neuraxial labor analgesia. If postpartum analgesic needs arise, patients in Group B will receive iboprufen and acetaminophen if needed.

Primary Outcome Measures

Name	Time	Method
ObsQoR-10 scores of postpartum patients	Patients' ObsQoR-10 scores will be determined at 24 hours postpartum	ObsQoR-10 scores of postpartum patients will be recorded before discharge

Trial Locations

Locations (1)

Atatürk University; 🇹🇷 Erzurum, Turkey