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Clinical Trials/NCT06325475
NCT06325475
Recruiting
Not Applicable

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.

Ataturk University1 site in 1 country40 target enrollmentMarch 26, 2024
ConditionsAnalgesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesia
Sponsor
Ataturk University
Enrollment
40
Locations
1
Primary Endpoint
ObsQoR-10 scores of postpartum patients
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2024
End Date
August 26, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aysenur Dostbil

clinical professor

Ataturk University

Eligibility Criteria

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

Outcomes

Primary Outcomes

ObsQoR-10 scores of postpartum patients

Time Frame: Patients' ObsQoR-10 scores will be determined at 24 hours postpartum

ObsQoR-10 scores of postpartum patients will be recorded before discharge

Study Sites (1)

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