Status:
COMPLETED
Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia
Lead Sponsor:
University of Chile
Conditions:
Labor Pain
Epidural Analgesia
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The rationale behind the dural puncture epidural (DPE) technique lies in the fact that a dural perforation with a spinal needle purportedly creates a conduit for accelerated translocation of local ane...
Eligibility Criteria
Inclusion
- healthy pregnant woman
- singleton and vertex presentation
- 37-42 weeks of gestational age
- active labor with cervical dilation \< 5cm
- body mass index between 20 and 35 kg/m2
- desired labor epidural analgesia
Exclusion
- adults who are unable to give their own consent
- presence of any pregnancy-related disease (e.g., gestational hypertension, preeclampsia, gestational diabetes)
- known fetal anomalies
- increased risk of cesarean delivery (e.g., previous uterine rupture, previous cesarean delivery)
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- allergy to LA
- prior sacral or lumbar spine surgery
Key Trial Info
Start Date :
January 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03389945
Start Date
January 13 2018
End Date
March 19 2019
Last Update
June 4 2020
Active Locations (2)
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1
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, Chile
2
Hospital La Florida
Santiago, Santiago Metropolitan, Chile