Viewing Study NCT03604068


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Study NCT ID: NCT03604068
Status: UNKNOWN
Last Update Posted: 2018-07-27
First Post: 2018-06-05
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Pulsed Short Wave Therapy In Cesarean Section
Sponsor: BioElectronics Corporation
Organization:

Study Overview

Official Title: Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section
Status: UNKNOWN
Status Verified Date: 2018-05
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following Cesarean section. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.
Detailed Description: Pain is ranked highest among undesirable clinical outcomes associated with caesarean section therefore postoperative pain relief following a cesarean section is extremely important to optimize maternal and neonate well being. Multimodial analgesics are effective in reducing postoperative pain but analgesia is still not optimized. Opiate based analgesics are effective but having troubling side effects. Addition of non-drug pain therapies hold promise in improving postoperative recovery while potentially allowing for reduced use of drug based analgesics.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: