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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06325475
Enrollment
40
Registered
2024-03-22
Start date
2024-03-26
Completion date
2024-08-26
Last updated
2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

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.

Interventions

PROCEDURElabor 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.

PROCEDURElabour 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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
ObsQoR-10 scores of postpartum patientsPatients' ObsQoR-10 scores will be determined at 24 hours postpartumObsQoR-10 scores of postpartum patients will be recorded before discharge

Countries

Turkey (Türkiye)

Contacts

Primary ContactAyşenur Dostbil
adostbil@hotmail.com+905333677796
Backup ContactAyşenur Dostbil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026