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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Page 1 of 1 (2 locations)

1

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

2

Hospital La Florida

Santiago, Santiago Metropolitan, Chile