Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000850077
Ethics application status
Approved
Date submitted
6/10/2010
Date registered
12/10/2010
Date last updated
3/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture Treatment for Threatened Miscarriage.
Scientific title
Acupuncture to reduce threatened miscarriage for women in early pregnancy compared to supportive care: a randomised feasibility study.
Secondary ID [1] 252830 0
Nil
Universal Trial Number (UTN)
Trial acronym
ACU MISS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Threatened miscarriage 258339 0
Condition category
Condition code
Alternative and Complementary Medicine 258524 258524 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A patient centered intervention (PCI) will be used to deliver the acupuncture treatment. In this approach the treatment design, the specific acupuncture system, style and techniques as well as explicit rational for diagnosis and treatment is tailored by the acupuncturist delivering the treatment to meet individual needs, but remains structured through manualisation
Acupuncture treatment that may include: needles, moxibustion therapy, cupping, dietary and lifestyle advice that is specific to the acupuncture diagnosis made by the acupuncturist. After making an acupuncture diagnosis the acupuncturist will select the treatment outlined as documented in a protocol manual compiled by the study investigator. This manual will be compiled using expert opinion from published texts detailing recommended treatment in the use of threatened miscarriage.
Treatment protocols will include:
Treatment based on an eight principals Traditional Chinese Medicine (TCM) diagnosis.
A selection of acupuncture points for each TCM diagnosis along with the appropriate indications for the use of moxibustion and or cupping.
Recommendations for dietary and lifestyle advice that is specific for each TCM diagnosis.
Needling specifications for needling depths according to a recognised acupuncture text (Deadman, Al-Khafaji, & Baker, 2001).
Treatment consists of two treatments in the first week of entering the trial followed by a weekly visit until participants reach 12 gestational weeks.
The initial treatment session will be 1 1/2 hours with the follow up sessions taking 3/4 of an hour. Each acupuncture treatment will involve a needling technique for obtaining deqi (the stimulation of the acupuncture needle to elicit a feeling of numbness, distension or heaviness around the acupuncture point) and a needle retention time of 20 minutes at each session.

A written sheet detailing dietary and lifestyle factors risk factors will also be given to women
Intervention code [1] 257353 0
Treatment: Other
Comparator / control treatment
The active control group will receive touch care in the form of light pressure applied to non acupuncture points to provide nonspecific therapeutic effects.
This touch treatment will consist of light pressure to each of the the following points for a time period of 5 minutes for each point.
With the points to used in the following order.
1 Dorsum of the foot. In the hollow distal to the junction of the 3rd and 4th metatarsal bones. Midway between the GB and ST channel, approximately at the level of the acupuncture point Liv 3.
2 Lower Leg. On the anterior crest of the tibia, 7 cun below the base of the patella. 1 cun distal and 1.5 cun medial to the acupuncture point ST 37.
3 Forearm. On the extensor surface of the forearm. Midway between LI and TH channels one cun distal and one cun lateral to LI 11
4 Hand. Dorsum of hand in the hollow distal to the base of the the 2nd and 3rd metacarpal bones. Midway between the SJ channel and the extra acupuncture point point Luozhen (M-UE-24), approximately at the level of the acupuncture point SI 3.
5 Chest. Antero lateral aspect of the chest. Inferior border of the clavicle, 5 cun lateral to the midline. Midway between the ST and LU channels – at the level of the acupuncture points ST 13 and LU 2.


Treatment consists of two treatments in the first week of entering the trial followed by a weekly visit until participants reach 12 weeks gestation. The initial treatment session will be 1 1/2 hours with the follow up sessions taking 3/4 of an hour.
A written sheet detailing dietary and lifestyle factors risk factors will also be given to women.
Control group
Active

Outcomes
Primary outcome [1] 259364 0
Feasibility of intervention through assessment of: recruitment procedures, recruitment rates, referral sources, eligibility criteria, consent rates, randomisation procedures and participants compliance and retention rates.
Timepoint [1] 259364 0
At conclusion of study
Primary outcome [2] 288447 0
Primary outcome 2
Ongoing clinical pregnancy
Timepoint [2] 288447 0
Timepoint: at 12 gestational weeks and at term
Secondary outcome [1] 265860 0
Preterm Birth
Timepoint [1] 265860 0
At delivery
Secondary outcome [2] 265861 0
Ante partum Haemorrhage (APH) as documented in hospital records. Defined as vaginal bleeding after the 20th week of gestation and before the onset of labour.
Timepoint [2] 265861 0
At delivery
Secondary outcome [3] 265862 0
Low birth weight as documented in hospital birthing records and defined as birthweight < 2500 gms
Timepoint [3] 265862 0
At delivery
Secondary outcome [4] 265863 0
Intrauterine growth restriction as documented in hospital birthing records and defined as a fetus whose estimated weight is below the 10th percentile for its gestational age and whose abdominal circumference is below the 25th percentile.
Timepoint [4] 265863 0
At delivery
Secondary outcome [5] 265864 0
Overall health of newborn , measured by Apgar score <7 at 5 minutes after birth as documented in hospital birthing records
Timepoint [5] 265864 0
At delivery
Secondary outcome [6] 265865 0
Maternal stress changes as documented from a pregnancy fear questionnaire
Timepoint [6] 265865 0
At baseline and then weekly untill 12 compleated gestational weeks
Secondary outcome [7] 265866 0
Maternal compliance with diet and lifestyle advice through analysing diary entries
Timepoint [7] 265866 0
At baseline and then weekly untill 12 compleated gestational weeks
Secondary outcome [8] 265867 0
Quality of life changes as measured through Measure Yourself Medical Outcome Profile (MYMOP) questionnaires
Timepoint [8] 265867 0
At baseline and then weekly untill 12 compleated gestational weeks
Secondary outcome [9] 265868 0
Hopital admission and length of stay for maternal miscarriage
Timepoint [9] 265868 0
At delivery
Secondary outcome [10] 265869 0
Admission to neonatal intensive care unit (NICU) and length of stay as documented in hospital records
Timepoint [10] 265869 0
At delivery

Eligibility
Key inclusion criteria
Women with sufficient English language skills to provide informed consent, vaginal bleeding and a viable pregnancy between 6 and 10 gestational weeks:
A viable pregnancy demonstrated through a transvaginal ultrasound examination confirming fetal cardiac activity
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with insufficient English language skills to provide informed consent, a nonviable pregnancy or ectopic pregnancy, twin or multiple pregnancy, women with three or more previous miscarriages, women with vaginal bleeding that consists of spotting of less than one day duration, women under the care of an obstetrician for underlying medical conditions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random sequence will be computer generated and concealed using an internet based randomization service.

Randomisation will be into two study groups, acupuncture plus supportive care and supportive care only.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated internet based randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2954 0
New Zealand
State/province [1] 2954 0

Funding & Sponsors
Funding source category [1] 257802 0
University
Name [1] 257802 0
University of Western Sydney - PhD Candidate funding
Country [1] 257802 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Centre for Complementary medicine Research
University of Western Sydney
Locked Bag 1797
Penrith South NSW 1797
Country
Australia
Secondary sponsor category [1] 257018 0
None
Name [1] 257018 0
Address [1] 257018 0
Country [1] 257018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259824 0
Lower South Regional Ethics Committee
Ethics committee address [1] 259824 0
Ministry of Health
229 Moray Place
P.O.Box 5849
Dunedin
Ethics committee country [1] 259824 0
New Zealand
Date submitted for ethics approval [1] 259824 0
Approval date [1] 259824 0
03/12/2010
Ethics approval number [1] 259824 0
LRS/10/07/030

Summary
Brief summary
Threatened miscarriage is a medical term used for vaginal bleeding during pregnancy when a baby is found to have a heart beat on ultrasound. While it is known that a majority of miscarriages in early pregnancy result from genetic abnormalities, there remain a percentage in which the cause remains unknown.
It may be possible that amongst this group of women in which genetic abnormalities is not the cause for vaginal bleeding, acupuncture may be used as a treatment for threatened miscarriage.
This study is designed to investigate if acupuncture can help women with threatened miscarriage and to examine their experience of receiving treatment. On entering the study women will be randomised into two groups – one group receiving acupuncture and one group receiving touch therapy, with both groups receiving diet and lifestyle advice. Treatment will continue until a pregnancy reaches 12 weeks gestation.
During this study women will receive an ultrasound at 12 weeks gestation, women will be required to keep a diary, a follow up phone call at 18-20 weeks gestation and birthing records will be examined to record the health of the mother and baby at birth. Some women may also be asked for an interview on their experience of the treatment they received.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31743 0
Address 31743 0
Country 31743 0
Phone 31743 0
Fax 31743 0
Email 31743 0
Contact person for public queries
Name 14990 0
Debra Betts
Address 14990 0
7 Jalna Ave
Khandallah
Wellington
6035
Country 14990 0
New Zealand
Phone 14990 0
+64 4 479 4054
Fax 14990 0
Email 14990 0
16910687@student.uws.edu.au
Contact person for scientific queries
Name 5918 0
Debra Betts
Address 5918 0
7 Jalna Ave
Khandallah
Wellington
6035
Country 5918 0
New Zealand
Phone 5918 0
+64 4 479 4054
Fax 5918 0
Email 5918 0
16910687@student.uws.edu.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
SourceTitleYear of PublicationDOI
EmbaseDoes acupuncture have a role in the treatment of threatened miscarriage? Findings from a feasibility randomised trial and semi-structured participant interviews.2016https://dx.doi.org/10.1186/s12884-016-1092-8
N.B. These documents automatically identified may not have been verified by the study sponsor.