None listed
Conditions
Brief summary
Stillbirth directly affects over 2,700 families in Australia and New Zealand each year and is associated with devastating and long-lasting psychosocial impact. Some late-pregnancy stillbirths may be preventable with early detection of a baby's ill-health, which may be indicated by Decreased Fetal Movements (DFM). Maternal reporting of (DFM) has therefore been proposed as a simple, inexpensive stillbirth screening tool. This trial will evaluate ‘My Baby’s Movements’ (MBM): a package of interventions to raise awareness and promote early reporting and optimal clinical management of DFM. MBM will be evaluated as part of a large multi-centre clinical trial across participating hospitals in Australia and New Zealand. Over three years, women attending for antenatal care with a singleton pregnancy will be included in measurement of stillbirth rates and other birth outcomes using routinely collected data. Maternal psychosocial outcomes, health service use, acceptability of MBM, and cost will also be assessed.
Interventions
My Baby's Movements (MBM): a package of interventions to raise awareness and promote early reporting and best-practice management of Decreased Fetal Movements (DFM) in the third-trimester of pregnancy, including a mobile phone application for pregnant women and e-learning program for clinicians.
MBM will be a personalised, user-controlled mobile phone software program that will provide information about fetal movement and when and how to report DFM. At a time and frequency determined by the wom
My Baby's Movements (MBM): a package of interventions to raise awareness and promote early reporting and best-practice management of Decreased Fetal Movements (DFM) in the third-trimester of pregnancy, including a mobile phone application for pregnant women and e-learning program for clinicians. MBM will be a personalised, user-controlled mobile phone software program that will provide information about fetal movement and when and how to report DFM. At a time and frequency determined by the woman, MBM will also send reminders to prompt awareness of fetal movements. Eligible women will be given a unique code to access MBM and become a registered user via their existing mobile phone. Women will be invited to use MBM from 28 weeks gestation to birth. Data generated from use of MBM (frequency and type of use, or discontinuation) will be sent to a secure database accessible to the research team. The e-learning program for clinicians will serve as education and training around the Australian and New Zealand clinical practice guidelines for the management of women who report DFM. The program will be computer-based and will seek to improve care around DFM. The program will take each clinician approximately 20 minutes to complete (one-sitting only), and can be used in ongoing hospital in-service education.
Sponsors
Associate Professor Vicki Flenady
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes
Inclusion criteria
Women with a singleton pregnancy attending for antenatal care at participating sites, and clinicians providing antenatal care at participating sites. Women at any stage of pregnancy are eligible for entry into the trial.
Exclusion criteria
Pregnant women with a lethal fetal congenital abnormality at 24-28 weeks' gestation.
Outcome results
None listed