ANSiStim Study for Active Labor Pain

Labor Pain Clinical Trial

— ANSS-ALP  

Official title:

Study of ANSiStim for Pain Relief During Active Labor Phase Through Continues Checking of VAS SCORE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02427139
• Other study ID #: ANSS-ALP 01
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2015
• Last updated: May 21, 2016
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: May 2016
• Source: DyAnsys, Inc.
• Contact: Murugesh K
• Phone: 04428133748
• Email: k.murugesh[@]dyansys.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The specific aim of the study is to do comparison between ANSiStim and Placebo for pain relief in labor. During the treatment, pain relief will be assesed with ANSiStim in active labor through continues checking of VAS SCORE. ANSiStim has been tried in post operative patients with good pain relief .

Description:

Pain during labor is caused by contractions of the muscles of the uterus and by pressure on the cervix. This pain can be felt as strong cramping in the abdomen, groin, and back, as well as an achy feeling. Some women experience pain in their sides or thighs as well. Most women have an epidural or spinal during labour or after the birth.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant Women on an Active Labor

Exclusion Criteria:

• Cardiac Pacemaker or any other implants

• Psoriasis

• Diminish mental capacity

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Labor Pain
• Obstetric Pain

Intervention

Device:
• ANSiStim
ANSiStim allows continuous point stimulation over a period of several days while offering the patient a high degree of comfort and mobility at the same time. Use of the ANSiSTIM therapy provides overwhelming advantage over drug therapy minimizing possible side-effects caused by pain medications (i.e. opioid) such as, for example, impaired reactions. In most cases, the patient continues to lead its life as normal, without side effects or any loss of quality of life.

Locations

Country	Name	City	State
India	Fortis Hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
DyAnsys, Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement		48 Hours	No