Status:
COMPLETED
Testing the Efficiency of a Device Meant to Relieve Labour Pain
Lead Sponsor:
ACU Medical Technologies Ltd
Conditions:
Labour Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
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 perf...
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 fo...
Eligibility Criteria
Inclusion
- Women with low-risk normal pregnancies.
- Healthy women, age 18 years or more.
- Single pregnancy
- At active labour, with contractions and labour pain.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00426725
Start Date
February 1 2007
End Date
December 1 2007
Last Update
August 1 2008
Active Locations (1)
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1
Laniado Hospital - Sanz Medical Center
Netanya, Israel