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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02427139
Other study ID # ANSS-ALP 01
Secondary ID
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


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
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