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Efficacy and Safety of Electrical Stimulation-guided Epidural Analgesia for Vaginal Delivery

NCT03161717 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-05-22

No results posted yet for this study

Summary

Forty pregnant women (36 to 41 weeks gestation) will randomly allocate to two groups. Groups will be defined based on the method used to identify the epidural space for epidural anesthesia: the loss of resistance group (n=20) and the epidural electrical stimulation group (n=20). Pain will be assessed using a numerical visual analog scale and maternal satisfaction by a post-partum interview. The success rate of epidural analgesia, maternal satisfaction, and neonatal Apgar scores will be compared between groups.

Conditions

  • Epidural Analgesia

Interventions

DEVICE

Epidural electrical stimulation (EES)

Using loss of resistance technique and electrical stimulation

DEVICE

Loss of resistance (LOR)

Using loss of resistance technique only

Sponsors & Collaborators

  • Sewoon Medical Co., Ltd

    collaborator INDUSTRY

  • Sang Sik Choi

    lead OTHER

Principal Investigators

  • Sang Sik Choi, MD, PhD · Korea University Guro Hiospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-11
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161717 on ClinicalTrials.gov