Clinical Trial: Testing the Efficiency of a Device Meant to Relieve Labour Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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 pregnan
    Sponsor: ACU Medical Technologies Ltd

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

    Original Primary Outcome: Mosby Pain Rating Scale (VAS)

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: ACU Medical Technologies Ltd

    Dates:
    Date Received: January 23, 2007
    Date Started: February 2007
    Date Completion:
    Last Updated: July 30, 2008
    Last Verified: July 2008