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

Ataturk University

Status: Enrolling

Conditions: Analgesia

Treatments: Procedure: labor with neuraxial labor analgesia; Procedure: labour without noroaxial labor analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06325475

B.30.2.ATA.0.01.00/530

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups

Group A

Active Comparator group

Description:

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.

Treatment:

Procedure: labor with neuraxial labor analgesia

Group B

Active Comparator group

Description:

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.

Treatment:

Procedure: labour without noroaxial labor analgesia