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Testing the Efficiency of a Device Meant to Relieve Labour Pain

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. Identifier: NCT00426725
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : August 1, 2008
Information provided by:
ACU Medical Technologies Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Labour Pain Device: EasyLabour Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
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
Study Start Date : February 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Mosby Pain Rating Scale (VAS) [ Time Frame: 6 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

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 identifier (NCT number): NCT00426725

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Laniado Hospital - Sanz Medical Center
Netanya, Israel
Sponsors and Collaborators
ACU Medical Technologies Ltd
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Principal Investigator: Shay Kevorkian, MD Laniado Sanz Hospital - Netanya - Israel
Layout table for additonal information Identifier: NCT00426725    
Other Study ID Numbers: ACUMT-07-KS-3811-CTIL
First Posted: January 25, 2007    Key Record Dates
Last Update Posted: August 1, 2008
Last Verified: July 2008
Keywords provided by ACU Medical Technologies Ltd:
Additional relevant MeSH terms:
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Labor Pain
Neurologic Manifestations