Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426725
Status:
COMPLETED
Last Update Posted:
2008-08-01
First Post:
2007-01-23
Brief Title:
Testing the Efficiency of a Device Meant to Relieve Labour Pain
Sponsor:
ACU Medical Technologies Ltd
Organization:
ACU Medical Technologies Ltd
Study Overview
Official Title:
Protocol for Testing the Efficiency of a Device Meant to Relieve Labour Pain
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 restrictionIUGR 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 parturients 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
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 restrictionIUGR 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 parturients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HTA3811 | None | None | None |