Status:
UNKNOWN
Study Comparing Dural Puncture Epidural With Epidural and Combined Spinal Epidural Anesthesia for Obstetric Analgesia.
Lead Sponsor:
Brugmann University Hospital
Conditions:
Obstetric Pain
Analgesia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This will be a prospective, randomized, double blind, controlled clinical trial. Epidural analgesia (EP) is currently the method of choice to ensure the comfort of the parturient during childbirth. T...
Eligibility Criteria
Inclusion
- Pregnant women at term (37-42 weeks of amenorrhea)
- American Society of Anesthesiologists (ASA) class 1 or 2
- no language barrier, i.e; speaking French, Dutch or English or accompanied by a reliable translator
- single pregnancy
- Parity 1 , 2 or 3
- cephalic fetal presentation
- active labor with cervical dilatation less than 5 cm
Exclusion
- Contraindications to neuraxial anesthesia
- major pathologies of pregnancy (preeclampsia)
- decompensated gestational diabetes
- diabetes type 1 or 2
- known serious fetal pathology
- maternal previous diseases increasing the risk of caesarean section (caesarean section, uterine malformation, scarred uterus, surgery of the uterine cervix)
- fourth or more deliveries
- extreme pre-pregnancy BMI (\< 18 or \> 40)
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05196256
Start Date
June 30 2022
End Date
July 30 2023
Last Update
February 24 2022
Active Locations (1)
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1
CHU Brugmann
Brussels, Belgium, 1020