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

March 16, 2024 updated by: Aysenur Dostbil, Ataturk University

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ayşenur Dostbil

Study Locations

  • Turkey
      • Erzurum, Turkey
        • Recruiting
        • Ataturk University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A

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.
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.
Active Comparator: Group B
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Patients' ObsQoR-10 scores will be determined at 24 hours postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Study Director: Aysenur Dostbil, Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 26, 2024

Primary Completion (Estimated)

July 26, 2024

Study Completion (Estimated)

August 26, 2024

Study Registration Dates

First Submitted

March 16, 2024

First Submitted That Met QC Criteria

March 16, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/530

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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