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Testing the Efficiency of a Device Meant to Relieve Labour Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426725
First Posted: January 25, 2007
Last Update Posted: August 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ACU Medical Technologies Ltd
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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
No Intervention: Control Device: EasyLabour
According to the trial protocol

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426725


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

ClinicalTrials.gov Identifier: NCT00426725     History of Changes
Other Study ID Numbers: ACUMT-07-KS-3811-CTIL
HTA3811
First Submitted: January 23, 2007
First Posted: January 25, 2007
Last Update Posted: August 1, 2008
Last Verified: July 2008

Keywords provided by ACU Medical Technologies Ltd:
labor
pain
relief
labour
device

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