ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000585426

Ethics application status

Approved

Date submitted

12/11/2007

Date registered

14/11/2007

Date last updated

14/11/2007

Type of registration

Prospectively registered

Titles & IDs

Public title

The Use of Acupressure Wristbands to Prevent Nausea and Vomiting in Labour and Delivery

Scientific title

A Randomized, Double-Blinded, Sham-Controlled Study to Evaluate the Antiemetic Efficacy of the Pressure Right Acupressure Wristband versus Placebo Bands.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Nausea and Vomiting

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Acupressure Wristbands applied to Nei-Kuan (P 6) acupoint
Bands to be applied from recruitment and kept in situ until 2 hours post delivery.

Intervention code [1]

Prevention

Intervention code [2]

Prevention

Comparator / control treatment

Sham wristbands

Control group

Placebo

Outcomes

Primary outcome [1]

Incidence of Nausea and/or Vomiting

Timepoint [1]

During 2 hourly time intervals throughout the study period (start of established labour until two hours after delivery)

Secondary outcome [1]

Incidence of Vomiting

Timepoint [1]

during 2 hourly time periods of study period

Secondary outcome [2]

Episodes of vomiting

Timepoint [2]

During study period

Secondary outcome [3]

Incidence of nausea

Timepoint [3]

During 2 hourly time intervals during study period

Secondary outcome [4]

Severity of Nausea - numerical rating scale 0-10

Timepoint [4]

During 2 hourly time intervals throughout study period

Secondary outcome [5]

Use of Rescue antiemetics

Timepoint [5]

during study period

Secondary outcome [6]

Maternal Satisfaction with control of nausea assertained from brief interview with mother.

Timepoint [6]

2 - 14 hours after delivery

Secondary outcome [7]

Inconvenience/discomfort associated with band
Assertained from brief interview with mother

Timepoint [7]

2- 14 hours after delivery

Eligibility

Key inclusion criteria

Term Pregnancy>/= 37 gestation
Admitted to delivery and confirmed as in the first stage of labour
American Society of Anaesthesiologists grade 1 and 2
Written informed consent

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Body Mass Index > 35
Current use of acupressure techniques or drugs with antiemetic activity
Nausea and vomiting within the previous 6 hours
sensitivity or allergy to adhesive tapes
Pre-term gestation
American Society of Anaesthesiologists grade 3 or 4
Intrauterine death or foetal abnomality
Non-English Speaking
Known intravenous drug user

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Each patient eligible will be seen by a member of the research team and given information about the trial verbally and via a patient information sheet. After giving written consent each participant will be allocated a sealed opaque envelope containing two wristbands ( either active or placebo) with instructions on how to apply them - these bands will be applied by the recruiting research team member and covered in a soft bandage to conceal band type from observers.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

340 subjects have been randomized in a 1:1 ratio (Active or Placebo) using a computer generated random number sequence and the appropriate band (Active or Placebo) plus application instuctions placed in numbered sealed envelopes

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

19/11/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

340

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6008

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Department of Anaesthetics and Pain Medicine

Address [1]

King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA
6008

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Therapeutics: 101 Inc

Address [2]

Tinton Falls
New Jersey
USA

Country [2]

United States of America

Primary sponsor type

Hospital

Name

Dr Melanie Thew

Address

Department of Anaesthetics and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Prof. Michael Paech

Address [1]

Department of Anaesthetics and Pain Medicine
King Edward Memorial Hospital for women
374 Bagot Road
Subiaco
WA 6008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

King Edward Memorial Hospital for Women Ethics Committee

Ethics committee address [1]

King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/11/2007

Ethics approval number [1]

1467/EW

Summary

Brief summary

Introduction
Feeling sick in labour is a common problem which can cause additional distress. These symptoms probably occur due to pain, anxiety and drug side effects. We are interested in studying the potential effect of using acupressure wrist bands to stop nausea and vomiting in this setting. This is a non-drug remedy, related to acupuncture, involving applying pressure to a point near the wrist. It has been shown to be successful in combating sickness in other situations such as post-operative nausea and vomiting, and morning sickness.
Aims/Objectives/Hypotheses
The study aims to look at the rates of sickness in women wearing acupressure wristbands (PressureRightTM) compared to baseline levels and those wearing dummy (placebo) bands.     
Study Population
We will be studying women who are in good health, aged18 years or older, in full term labour admitted to the labour ward and who consent to taking part in our trial. They will receive information about the project and they will be able to withdraw from the study at any time.
We will not be looking at women who are morbidly obese, known to be intravenous drug users, have an allergy to tapes, have an abnormal or dead baby, do not speak English, and/or are using acupressure techniques or medications to treat nausea already. 
Methods
Women who have agreed and signed a written consent will be randomly assigned to one of the two groups, treatment group with the bands applied correctly and placebo group with dummy (placebo) bands. Both types of bands will be covered. We will collect baseline information such as age, weight, height, pregnancy details, smoking status, history of motion sickness, progress of labour, use of medications, presence of initial nausea and pain. Further information will be collected during the labour by way of a simple form (with midwife help). This will include sickness and pain severity. The rest of the required information including the use of any medications during labour, use of an epidural, basic observations such as blood pressure, and the level of satisfaction with their care will be collected post delivery. 
Ethical Issues
There are no significant ethical issues in the performance of this study.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Prof. M. Paech

Address

Department of Anaesthetics and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008

Country

Australia

Phone

+61 8 9340 2250

Fax

+61 8 9340 2260

michael.paech@health.wa.gov.au

Contact person for scientific queries

Name

Prof. M. Paech

Address

Department of Anaesthetics and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
WA 6008

Country

Australia

Phone

+61 8 9340 2250

Fax

+61 8 9340 2260

michael.paech@health.wa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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