Testing the Efficiency of a Device Meant to Relieve Labour Pain

July 30, 2008 updated by: ACU Medical Technologies Ltd

Protocol for Testing the Efficiency of a Device Meant to Relieve Labour Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical Trial Design A prospective controlled study meant to scientifically test the feasibility of a device to alleviate labour pain.

  • Every woman will sign an informed consent form.
  • Guidance for proper and safe use of the device will be given by specially trained midwives.
  • The study will be performed at the Laniado Hospital-Sanz Medical Center, Netanya, Israel.
  • The study group will consist of 60 women, 30 in each group.
  • Eligibility : Ages Eligible for study is 18 years and up.

Participants:

  • The study group shall consists of 30 parturients at active labour, with contractions, demanding to receive analgesia. The device will be given, with guidance from a pre-trained midwife and under professional supervision. This study group will include also women choosing to continue using it till the application of epidural analgesia.
  • The control group shall consists of 30 parturients at active labour, with contractions, choosing to receive epidural analgesia.

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.

Criteria for taking out of the study:

Upon parturient's demand. Analgesia will be given upon parturient demand.

Method:

Parturients arriving at the delivery room and fitting the criteria will randomly divided into two groups: the study group, which will use the device, and the control group.

Intensity of pain will be measured in five different stages:

  1. Before they put on the device.
  2. Five minutes after starting to use the device.
  3. After 30 minutes of use.
  4. The device will be turned off for the duration of three consecutive contractions after which pain intensity will be measured.

  5. The device will be turned on and pain intensity will be measured after 5 minutes of renewed use.

    • Pain intensity will be measured and defined by the participants using the Mosby Pain Rating Scale (see attached document).
    • The device will be attached to participants with uterine contractions with a frequency of at least 3 contractions every 10 minutes and cervical dilatation of at least 2 cm.
    • Both groups will be divided according to 3 age subgroups: 18 to 30, 31 to 40, and 41 to 45.
    • A further division will be according to BMI: below BMI 20, 20 to 25, and above a BMI of 25.

In both groups 6 indexes will be measured:

  1. Comparison of pain intensity between subjects of both groups.
  2. Stage of application of analgesia, epidural or other.
  3. Length of second stage of birth.
  4. Rate of instrumental deliveries.
  5. Rate of Caesarean Sections due to non-advancement progressive labour, arrest of cervical dilatation, or arrest of fetal head descent .

Rate of fetal non reassuring monitor, like fetal deceleration or low variability.

Study length:

The study may take around one year, or till enough cases are collected in both groups.

Definition of success:

Success will be defined as proof of labour pain relief achievement, measured as a difference between the study and control groups, among participants in the study group, according to statistical criteria as are customary in similar studies. Exceptional success will be considered if statistical proof could be observed that using the device shortens delivery length of time, or, that using of the device diminishes the usage of epidural analgesia.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Netanya, Israel
        • Laniado Hospital - Sanz Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Device: EasyLabour
According to the trial protocol
Experimental: A
This group uses the EasyLabour device according to the protocol
Device: EasyLabour
According to the trial protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mosby Pain Rating Scale (VAS)
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ACU Medical Technologies Ltd

Investigators

  • Principal Investigator: Shay Kevorkian, MD, Laniado Sanz Hospital - Netanya - Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 23, 2007

First Submitted That Met QC Criteria

January 23, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

August 1, 2008

Last Update Submitted That Met QC Criteria

July 30, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACUMT-07-KS-3811-CTIL
  • HTA3811

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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