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