ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

ACU MISS

Linked study record

Health condition

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

Threatened miscarriage

Condition category

Condition code

Alternative and Complementary Medicine

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]

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]

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]

At conclusion of study

Primary outcome [2]

Primary outcome 2
Ongoing clinical pregnancy

Timepoint [2]

Timepoint: at 12 gestational weeks and at term

Secondary outcome [1]

Preterm Birth

Timepoint [1]

At delivery

Secondary outcome [2]

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]

At delivery

Secondary outcome [3]

Low birth weight as documented in hospital birthing records and defined as birthweight < 2500 gms

Timepoint [3]

At delivery

Secondary outcome [4]

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]

At delivery

Secondary outcome [5]

Overall health of newborn , measured by Apgar score <7 at 5 minutes after birth as documented in hospital birthing records

Timepoint [5]

At delivery

Secondary outcome [6]

Maternal stress changes as documented from a pregnancy fear questionnaire

Timepoint [6]

At baseline and then weekly untill 12 compleated gestational weeks

Secondary outcome [7]

Maternal compliance with diet and lifestyle advice through analysing diary entries

Timepoint [7]

At baseline and then weekly untill 12 compleated gestational weeks

Secondary outcome [8]

Quality of life changes as measured through Measure Yourself Medical Outcome Profile (MYMOP) questionnaires

Timepoint [8]

At baseline and then weekly untill 12 compleated gestational weeks

Secondary outcome [9]

Hopital admission and length of stay for maternal miscarriage

Timepoint [9]

At delivery

Secondary outcome [10]

Admission to neonatal intensive care unit (NICU) and length of stay as documented in hospital records

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Western Sydney - PhD Candidate funding

Address [1]

Centre for Complementary medicine Research
University of Western Sydney
Locked Bag 1797
Penrith South NSW 1797

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Lower South Regional Ethics Committee

Ethics committee address [1]

Ministry of Health 
229 Moray Place 
P.O.Box 5849
Dunedin

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

03/12/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Debra Betts

Address

7 Jalna Ave
Khandallah
Wellington
6035

Country

New Zealand

Phone

+64 4 479 4054

Fax

16910687@student.uws.edu.au

Contact person for scientific queries

Name

Debra Betts

Address

7 Jalna Ave
Khandallah
Wellington
6035

Country

New Zealand

Phone

+64 4 479 4054

Fax

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

Source	Title	Year of Publication	DOI
Embase	Does acupuncture have a role in the treatment of threatened miscarriage? Findings from a feasibility randomised trial and semi-structured participant interviews.	2016	https://dx.doi.org/10.1186/s12884-016-1092-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically