Testing the Efficiency of a Device Meant to Relieve Labour Pain - Full Text View

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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
A: Experimental This group uses the EasyLabour device according to the protocol	Device: EasyLabour According to the trial protocol
Control: No Intervention	Device: EasyLabour According to the trial protocol

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

Keywords provided by ACU Medical Technologies Ltd:

labor

pain

relief

labour

device

Study placed in the following topic categories:

Signs and Symptoms

Labor Pain

Neurologic Manifestations

Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	ACU Medical Technologies Ltd
Information provided by:	ACU Medical Technologies Ltd
ClinicalTrials.gov Identifier:	NCT00426725