None listed
Conditions
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.
Interventions
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
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
Sponsors
University of Western Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
No
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
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.
Outcome results
None listed