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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06325475
Other study ID # B.30.2.ATA.0.01.00/530
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 26, 2024
Est. completion date August 26, 2024

Study information

Verified date March 2024
Source Ataturk University
Contact Aysenur Dostbil
Phone +905333677796
Email adostbil@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 26, 2024
Est. primary completion date July 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Atatürk University Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31. — View Citation

Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ObsQoR-10 scores of postpartum patients ObsQoR-10 scores of postpartum patients will be recorded before discharge Patients' ObsQoR-10 scores will be determined at 24 hours postpartum
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