Testing the Efficiency of a Device Meant to Relieve Labour Pain

This study has been completed.
Information provided by:
ACU Medical Technologies Ltd
ClinicalTrials.gov Identifier:
First received: January 23, 2007
Last updated: July 30, 2008
Last verified: July 2008

The suggested research is aimed to test the effectiveness of an external mechanical device to be applied and used by the parturient herself in pain relieving during labour . The research is to be performed in a controlled closely observed way, to ensure the safety of the involved parturient and newborn.

Condition Intervention
Labour Pain
Device: EasyLabour

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Protocol for Testing the Efficiency of a Device Meant to Relieve Labour Pain

Further study details as provided by ACU Medical Technologies Ltd:

Primary Outcome Measures:
  • Mosby Pain Rating Scale (VAS) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
This group uses the EasyLabour device according to the protocol
Device: EasyLabour
According to the trial protocol
Other Name: EasyLabour
No Intervention: Control Device: EasyLabour
According to the trial protocol
Other Name: EasyLabour

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Women with low-risk normal pregnancies.
  • Healthy women, age 18 years or more.
  • Single pregnancy
  • At active labour, with contractions and labour pain.

Exclusion Criteria:

  • Women at high risk pregnancies (with Diabetes Mellitus, Arterial Hypertension, multiple fetal pregnancy, abnormal amniotic fluid index, Intra Uterine growth restriction(IUGR), or any situation which might imply placental insufficiency)
  • Caesarean sections in the past
  • Any contraindication to vaginal delivery (as breech presentation or Placenta Previa).
  • Any active illness, abnormal body temperature, Fatigue, etc.
  • Women complaining of any pain nonrelated to labour.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426725

Laniado Hospital - Sanz Medical Center
Netanya, Israel
Sponsors and Collaborators
ACU Medical Technologies Ltd
Principal Investigator: Shay Kevorkian, MD Laniado Sanz Hospital - Netanya - Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00426725     History of Changes
Other Study ID Numbers: ACUMT-07-KS-3811-CTIL, HTA3811
Study First Received: January 23, 2007
Last Updated: July 30, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by ACU Medical Technologies Ltd:

Additional relevant MeSH terms:
Labor Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014