Comparison of Patients' Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia
NCT ID: NCT06325475
Last Updated: 2024-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-03-26
2024-08-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Pregnant women consenting to neuraxial analgesia for labor
* Being ≥37 weeks gestation
Exclusion Criteria
* Being \<18 years old
* Being \<37 weeks gestation
18 Years
40 Years
FEMALE
Yes
Sponsors
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Ataturk University
OTHER
Responsible Party
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Aysenur Dostbil
clinical professor
Principal Investigators
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Ayşenur Dostbil
Role: STUDY_DIRECTOR
Ataturk University
Locations
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Atatürk University
Erzurum, , Turkey (Türkiye)
Countries
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Central Contacts
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Ayşenur Dostbil
Role: CONTACT
Facility Contacts
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References
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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.
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.
Other Identifiers
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B.30.2.ATA.0.01.00/530
Identifier Type: -
Identifier Source: org_study_id
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