NCT06325475

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 16, 2024

Last Update Submit

March 16, 2024

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Interventions

labor with neuraxial labor analgesiaPROCEDURE

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 A
labour without noroaxial labor analgesiaPROCEDURE

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.

Group B

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being ≥18 years old
  • Pregnant women consenting to neuraxial analgesia for labor
  • Being ≥37 weeks gestation

You may not qualify if:

  • Patients in whom neuraxial analgesia is contraindicated
  • Being \<18 years old
  • Being \<37 weeks gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32203873BACKGROUND

  • 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.

    PMID: 30579408BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayşenur Dostbil

    Ataturk University

    STUDY DIRECTOR

Central Study Contacts

Ayşenur Dostbil

CONTACT

+905333677796adostbil@hotmail.com

Ayşenur Dostbil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

March 16, 2024

First Posted

March 22, 2024

Study Start

March 26, 2024

Primary Completion

July 26, 2024

Study Completion

August 26, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations

TU(1)