Status:
RECRUITING
Dural Puncture Epidural VS Standard Epidural on Physician Top-ups During Labour Analgesia
Lead Sponsor:
Ciusss de L'Est de l'Île de Montréal
Conditions:
Obstetric Pain
Labor Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this prospective randomized controlled study is to compare the number of physician top-up interventions during the first stage of labour between two different neuraxial analgesia techni...
Detailed Description
Providing adequate labour analgesia has always been an important issue in obstetrical anesthesia. Different types of neuraxial techniques include standard epidural analgesia (EPL), combined spinal epi...
Eligibility Criteria
Inclusion
- Healthy pregnant women (ASA 1 and 2) requesting epidural analgesia during labour.
- Primiparous and multiparous parturients at term gestation (37 to 42 weeks).
- Women 18 years old and older.
- Administration of epidural analgesia between 7am and 4pm on weekdays.
- Singleton and vertex presentation foetus.
- Cervical dilatation ≤ 5 cm.
- BMI ≤ 40.
- French speaking
Exclusion
- Pregnancy diseases such as gestational hypertension, preeclampsia and gestational diabetes.
- Contraindications to neuraxial analgesia: thrombocytopenia \< 70 x 109/L, spinal cord anomalies, anticoagulation therapy, etc.
- Known important fetal anomalies.
- Allergy to any of the medications used in the study.
- Suspected chorioamnionitis with spontaneous premature rupture of membranes (PROM).
- Difficulty understanding and speaking French.
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04728048
Start Date
January 19 2021
End Date
December 1 2025
Last Update
July 17 2024
Active Locations (1)
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1
CIUSSS de l'Est de l'Île de Montréal
Montreal, Quebec, Canada, H1T2M4