Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000145707
Ethics application status
Not yet submitted
Date submitted
5/02/2013
Date registered
6/02/2013
Date last updated
21/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of acupressure to assist spontaneous labour for women who are pregnant for the first time experiencing post-date pregnancy: A pilot study
Scientific title
In primigravida women experiencing post-dates pregnancy, how does the use of specific acupressure points compared to women receiving usual antenatal care only influence the onset of spontaneous labour to avoid medical induction at 41 weeks.
Secondary ID [1] 281909 0
Nil known
Universal Trial Number (UTN)
U1111-1138-9154
Trial acronym
PR.E.P.A.RE: PRimigravidas Experiencing Post-dates and Acupressure REsearch.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-date pregnancy ie 41 weeks gestation or greater 288182 0
Condition category
Condition code
Alternative and Complementary Medicine 288540 288540 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Usual care and acpuressure points. The acupressure protocol has been developed by the Chief Investigator Lyndall Mollart based on the literature review and in consultation with Debra Betts, an internationally recognised leader in acupuncture and acupressure (Betts 2003).
At 41 weeks gestation and randomised to the invention (acupressure group), the woman and partner/support person will be shown the three bilateral points: SP6 [lower leg], LI4 [hand], GB21 [shoulder]. They will be instructed on how to apply sustained bilateral pressure using thumb or finger for:
2 minutes on point SP6 [lower leg] followed by 2 minutes on LI4 [hand] every 2 hours during the day; and 2 minutes on point GB21 [shoulder point] twice a day (morning and evening) daily. The women will be instructed to continue to use accupressure until onset of labour
The women will also receive a written instruction sheet with diagrams showing the location of the points and description on the usage i.e. timing and frequency. A diary sheet to keep a daily record on the frequency and use of the points will be provided to the women. The research assistant will contact the woman one to two days after the 41 week antenatal visit to discuss the use of the acupressure points and if further education is required.


Usual antenatal care at 40 weeks and 10 days: The participant will be advised of her next clinic/ Day Assessment Unit (DAU) appointment at approximately 40wks+10 days (+/- 2 days) for assessment for medical induction and date given for medical induction (by 40 weeks and 14 days). Maternal and fetal assessment includes abdominal palpation, vaginal examination to determine Bishop score, and CTG (fetal electronic monitoring).
Intervention code [1] 286381 0
Treatment: Other
Comparator / control treatment
No acupressure points to be used. Usual antenatal care at 40 weeks and 10 days: The participant will be advised of her next clinic/ Day Assessment Unit (DAU) appointment at approximately 40wks+10 days (+/- 2 days) for assessment for medical induction and date given for medical induction (by 40 weeks and 14 days). Maternal and fetal assessment includes abdominal palpation, vaginal examination to determine Bishop score, and CTG (fetal electronic monitoring).
Control group
Active

Outcomes
Primary outcome [1] 288703 0
This study aims to determine whether primigravida women who are experiencing post-date pregnancy (41 weeks gestation) are more likely to experience spontaneous onset of labour using specific acupressure points than women receiving usual antenatal care only.
Timepoint [1] 288703 0
Obstetric outcomes within 5-7 days after recruitment.
Secondary outcome [1] 300790 0
The secondary aim with a patient survey is to explore the women’s experience on the care received and being randomised. For women allocated to the acupressure group, there is an additional section on the acupressure point education and information, and whether or not they used the acupressure points during pregnancy and labour, and any impact on partner involvement.
Timepoint [1] 300790 0
Patient survey within 10 days after birthing

Eligibility
Key inclusion criteria
Patients who meet the study inclusion criteria will be recruited from maternity services, based at Gosford and Wyong Hospitals. All eligible women receiving care at the study sites will be invited to participate. The inclusion criteria are: primigravid women of gestation at 41 weeks gestation or greater, with a singleton pregnancy; fetus in a cephalic presentation; English speaking; age of 18 years and over;
receiving antenatal care with a midwifery model of care (as NSW PD 2010_022 Maternity- National Midwifery Guidelines for Consultation and Referral).
Minimum age
18 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
women experiencing regular uterine contractions (established labour); Contra-indication to induction of labour or vaginal birth; Women do not speak or read English will be unfairly discriminated against in the study, in the absence of a budget for adequate translation services for the written materials that are designed to facilitate informed consent. Regardless of the model of care that women access at Gosford maternity, service interpreter services are made available to them but this cannot always be guaranteed; Women with an intellectual or mental impairment may be disadvantaged in the process of giving informed consent. These women will need to access extra services from the mental health team at Gosford Hospital in order to negotiate decision making regarding the study and randomisation; Women who are highly dependent on medical care would require specialist medical/obstetric consultation and will usually have medical intervention prior to 41 weeks gestation; Women who are currently using Acupressure for post dates

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)
At the 40 week antenatal visit, the midwife will identify if the woman meets the eligibility criteria (as above). If eligible, the midwife will provide the woman with the project information sheet and consent form. The midwife will inform the research assistant (RA) of the date and time of the next appointment for each woman who has received the project information.

At the 41 week antenatal visit, the RA will approach each woman and ask if she received the information and whether she is interested in participating. If a woman expresses interest, the RA will re-check that the woman meets the eligibility criteria and will discuss the research and provide a consent form. Consenting women will be randomised using a remote internet allocation services.

If allocated to usual antenatal care, the woman will be advised of her next clinic/ Day Assessment Unit (DAU) appointment for assessment for medical induction and date given for medical induction (prior to 42 weeks gestation). Participants randomised to the intervention will receive information, education, and instruction in the use acupressure for three points by the midwife/RA. The participant will also be advised of the next clinic/DAU appointment for assessment for medical induction and date given for medical induction (prior to 42 weeks gestation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
At the 41 week antenatal visit, the midwife or RA will approach each eligible woman and ask if she received the information and whether she is interested in participating. If a woman expresses interest, the RA will re-check that the woman meets the eligibility criteria and will discuss the research and provide a consent form. Consenting women will be randomised (using random permuted blocks) via a remote internet allocation services.

If allocated to usual antenatal care, the woman will be advised of her next clinic/ Day Assessment Unit (DAU) appointment for assessment for medical induction and date given for medical induction (prior to 42 weeks gestation). Participants randomised to the intervention will receive information, education, and instruction in the use acupressure for three points by the midwife/RA. The participant will also be advised of the next clinic/DAU appointment for assessment for medical induction and date given for medical induction (prior to 42 weeks gestation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be analysed using the Statistical Package for Social Science V18.0 (SPSS) in consultation with the statistician.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/02/2013
Actual
13/02/2013
Date of last participant enrolment
Anticipated
28/06/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 466 0
Gosford Hospital - Gosford
Recruitment hospital [2] 467 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment postcode(s) [1] 6217 0
2250 - Gosford
Recruitment postcode(s) [2] 6218 0
2259 - Hamlyn Terrace

Funding & Sponsors
Funding source category [1] 286695 0
Government body
Name [1] 286695 0
NSW Ministry of Health
Country [1] 286695 0
Australia
Primary sponsor type
Government body
Name
NSW Ministry of Health
Address
Nursing and Midwifery Office
NSW Health
73 Miller St
North Sydney
NSW 2060
Country
Australia
Secondary sponsor category [1] 285466 0
None
Name [1] 285466 0
Address [1] 285466 0
Country [1] 285466 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288685 0
The Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 288685 0
Ethics committee country [1] 288685 0
Australia
Date submitted for ethics approval [1] 288685 0
09/08/2012
Approval date [1] 288685 0
Ethics approval number [1] 288685 0
12/HAWKE/281

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37278 0
Ms Lyndall Mollart
Address 37278 0
Antenatal Clinics
Maternity Services
Women's, Childrens and Family Division
Gosford Hospital
PO Box 361
Gosford, NSW, 2250
Country 37278 0
Australia
Phone 37278 0
+61 2 43202461
Fax 37278 0
Email 37278 0
[email protected]
Contact person for public queries
Name 37279 0
Lyndall Mollart
Address 37279 0
Antenatal Clinics
Maternity Services
Gosford Hospital
PO Box 361
Gosford, NSW, 2250
Country 37279 0
Australia
Phone 37279 0
+61 2 43202461
Fax 37279 0
Email 37279 0
[email protected]
Contact person for scientific queries
Name 37280 0
Lyndall Mollart
Address 37280 0
Antenatal Clinics
Maternity Services
Gosford Hospital
PO Box 361
Gosford, NSW, 2250
Country 37280 0
Australia
Phone 37280 0
+61 2 43202461
Fax 37280 0
Email 37280 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseA feasibility randomised controlled trial of acupressure to assist spontaneous labour for primigravid women experiencing a post-date pregnancy.2016https://dx.doi.org/10.1016/j.midw.2016.02.020
N.B. These documents automatically identified may not have been verified by the study sponsor.