RecruitingACTRN12614000291684

My Baby’s Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy

My Baby’s Movements: A mobile phone software program about maternal fetal movement awareness, designed for women with a singleton pregnancy to prevent stillbirth at 28 weeks' gestation or more


Sponsor

Associate Professor Vicki Flenady

Enrollment

300,000 participants

Start Date

Nov 28, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is evaluating a program called 'My Baby's Movements' (MBM), which aims to raise awareness among pregnant women about monitoring their baby's movements. Reduced fetal movements can be a warning sign that a baby is unwell. The program includes education and tools to help women recognise and report changes early. The study will track stillbirth rates and other birth outcomes across hospitals in Australia and New Zealand. You may be eligible if: - You are pregnant with a single baby (singleton pregnancy) - You are attending antenatal care at a participating hospital - You are at any stage of pregnancy You may NOT be eligible if: - Your baby has been diagnosed with a serious birth defect that is unlikely to be compatible with life at 24–28 weeks of pregnancy Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(19)

Gold Coast University Hospital - Southport

ACT,NSW,NT,QLD,SA, Australia

Logan Hospital - Meadowbrook

ACT,NSW,NT,QLD,SA, Australia

Ipswich Hospital - Ipswich

ACT,NSW,NT,QLD,SA, Australia

Nepean Hospital - Kingswood

ACT,NSW,NT,QLD,SA, Australia

Liverpool Hospital - Liverpool

ACT,NSW,NT,QLD,SA, Australia

The Canberra Hospital - Garran

ACT,NSW,NT,QLD,SA, Australia

Monash Medical Centre - Clayton campus - Clayton

ACT,NSW,NT,QLD,SA, Australia

Dandenong Hospital - Dandenong

ACT,NSW,NT,QLD,SA, Australia

Casey Hospital - Berwick

ACT,NSW,NT,QLD,SA, Australia

Sunshine Hospital - St Albans

ACT,NSW,NT,QLD,SA, Australia

Royal Prince Alfred Hospital - Camperdown

ACT,NSW,NT,QLD,SA, Australia

Royal Hospital for Women - Randwick

ACT,NSW,NT,QLD,SA, Australia

Royal North Shore Hospital - St Leonards

ACT,NSW,NT,QLD,SA, Australia

Mater Mother's Hospital - South Brisbane

ACT,NSW,NT,QLD,SA, Australia

Royal Brisbane & Womens Hospital - Herston

ACT,NSW,NT,QLD,SA, Australia

The Royal Women's Hospital - Parkville

ACT,NSW,NT,QLD,SA, Australia

Mercy Hospital for Women - Heidelberg

ACT,NSW,NT,QLD,SA, Australia

The Northern Hospital - Epping

ACT,NSW,NT,QLD,SA, Australia

New Zealand

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ACTRN12614000291684