My Baby's Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol.
Adult
Australia
/ epidemiology
Female
Fetal Movement
Health Knowledge, Attitudes, Practice
Humans
Mobile Applications
New Zealand
/ epidemiology
Patient Acceptance of Health Care
/ psychology
Patient Education as Topic
/ methods
Pregnancy
Prenatal Care
/ methods
Randomized Controlled Trials as Topic
Stillbirth
/ epidemiology
Best practice
Decreased fetal movements
Maternity care
Mobile phone application
Stillbirth
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
21 Nov 2019
21 Nov 2019
Historique:
received:
08
07
2019
accepted:
31
10
2019
entrez:
23
11
2019
pubmed:
23
11
2019
medline:
25
4
2020
Statut:
epublish
Résumé
Stillbirth is a devastating pregnancy outcome that has a profound and lasting impact on women and families. Globally, there are over 2.6 million stillbirths annually and progress in reducing these deaths has been slow. Maternal perception of decreased fetal movements (DFM) is strongly associated with stillbirth. However, maternal awareness of DFM and clinical management of women reporting DFM is often suboptimal. The My Baby's Movements trial aims to evaluate an intervention package for maternity services including a mobile phone application for women and clinician education (MBM intervention) in reducing late gestation stillbirth rates. This is a stepped wedge cluster randomised controlled trial with sequential introduction of the MBM intervention to 8 groups of 3-5 hospitals at four-monthly intervals over 3 years. The target population is women with a singleton pregnancy, without lethal fetal abnormality, attending for antenatal care and clinicians providing maternity care at 26 maternity services in Australia and New Zealand. The primary outcome is stillbirth from 28 weeks' gestation. Secondary outcomes address: a) neonatal morbidity and mortality; b) maternal psychosocial outcomes and health-seeking behaviour; c) health services utilisation; d) women's and clinicians' knowledge of fetal movements; and e) cost. 256,700 births (average of 3170 per hospital) will detect a 30% reduction in stillbirth rates from 3/1000 births to 2/1000 births, assuming a significance level of 5%. Analysis will utilise generalised linear mixed models. Maternal perception of DFM is a marker of an at-risk pregnancy and commonly precedes a stillbirth. MBM offers a simple, inexpensive resource to reduce the number of stillborn babies, and families suffering the distressing consequences of such a loss. This large pragmatic trial will provide evidence on benefits and potential harms of raising awareness of DFM using a mobile phone app. ACTRN12614000291684. Registered 19 March 2014. Protocol Version 6.1, February 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Stillbirth is a devastating pregnancy outcome that has a profound and lasting impact on women and families. Globally, there are over 2.6 million stillbirths annually and progress in reducing these deaths has been slow. Maternal perception of decreased fetal movements (DFM) is strongly associated with stillbirth. However, maternal awareness of DFM and clinical management of women reporting DFM is often suboptimal. The My Baby's Movements trial aims to evaluate an intervention package for maternity services including a mobile phone application for women and clinician education (MBM intervention) in reducing late gestation stillbirth rates.
METHODS/DESIGN
METHODS
This is a stepped wedge cluster randomised controlled trial with sequential introduction of the MBM intervention to 8 groups of 3-5 hospitals at four-monthly intervals over 3 years. The target population is women with a singleton pregnancy, without lethal fetal abnormality, attending for antenatal care and clinicians providing maternity care at 26 maternity services in Australia and New Zealand. The primary outcome is stillbirth from 28 weeks' gestation. Secondary outcomes address: a) neonatal morbidity and mortality; b) maternal psychosocial outcomes and health-seeking behaviour; c) health services utilisation; d) women's and clinicians' knowledge of fetal movements; and e) cost. 256,700 births (average of 3170 per hospital) will detect a 30% reduction in stillbirth rates from 3/1000 births to 2/1000 births, assuming a significance level of 5%. Analysis will utilise generalised linear mixed models.
DISCUSSION
CONCLUSIONS
Maternal perception of DFM is a marker of an at-risk pregnancy and commonly precedes a stillbirth. MBM offers a simple, inexpensive resource to reduce the number of stillborn babies, and families suffering the distressing consequences of such a loss. This large pragmatic trial will provide evidence on benefits and potential harms of raising awareness of DFM using a mobile phone app.
TRIAL REGISTRATION
BACKGROUND
ACTRN12614000291684. Registered 19 March 2014.
VERSION
UNASSIGNED
Protocol Version 6.1, February 2018.
Identifiants
pubmed: 31752771
doi: 10.1186/s12884-019-2575-1
pii: 10.1186/s12884-019-2575-1
pmc: PMC6873438
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
430Références
Lancet. 1989 Aug 12;2(8659):345-9
pubmed: 2569550
Aust N Z J Obstet Gynaecol. 2009 Aug;49(4):358-63
pubmed: 19694688
BMC Pregnancy Childbirth. 2009 Jul 22;9:32
pubmed: 19624847
PLoS One. 2017 Jun 6;12(6):e0178727
pubmed: 28586367
J Matern Fetal Neonatal Med. 2010 Oct;23(10):1129-35
pubmed: 20476880
Birth. 2012 Mar;39(1):10-20
pubmed: 22369601
Lancet. 2011 Apr 16;377(9774):1353-66
pubmed: 21496915
BMJ. 1992 Jul 18;305(6846):160-4
pubmed: 1285753
Lancet. 2016 Feb 6;387(10018):604-616
pubmed: 26794073
Lancet. 2011 Apr 16;377(9774):1331-40
pubmed: 21496916
Lancet. 2016 Feb 6;387(10018):587-603
pubmed: 26794078
Lancet. 2011 May 7;377(9777):1610-23
pubmed: 21496910
BMC Pregnancy Childbirth. 2016 Jul 19;16(1):169
pubmed: 27430891
Stat Med. 2007 Jan 15;26(1):2-19
pubmed: 17136746
West J Nurs Res. 1993 Apr;15(2):199-211; discussion 211-5
pubmed: 8470375
Birth. 2011 Dec;38(4):311-6
pubmed: 22112331
Cochrane Database Syst Rev. 2015 Oct 15;(10):CD004909
pubmed: 26467769
Lancet. 1987 May 23;1(8543):1192-4
pubmed: 2883499
Contemp Clin Trials. 2007 Feb;28(2):182-91
pubmed: 16829207
Lancet. 2011 May 21;377(9779):1798-805
pubmed: 21496912
Lancet. 2018 Nov 3;392(10158):1629-1638
pubmed: 30269876
J Midwifery Womens Health. 2008 Jul-Aug;53(4):345-52
pubmed: 18586188
Semin Perinatol. 2008 Aug;32(4):243-6
pubmed: 18652921
Lancet. 2011 May 14;377(9778):1703-17
pubmed: 21496907
Aust N Z J Obstet Gynaecol. 2018 Aug;58(4):463-468
pubmed: 29355899
Aust J Prim Health. 2013;19(4):313-8
pubmed: 23899373
JMIR Mhealth Uhealth. 2018 Aug 09;6(8):e10012
pubmed: 30093368
J Perinat Med. 2004;32(1):13-24
pubmed: 15008381
J Obstet Gynaecol. 2008 Feb;28(2):147-54
pubmed: 18393008
Br J Psychiatry. 1987 Jun;150:782-6
pubmed: 3651732
Clin Perinatol. 2008 Jun;35(2):325-41, vi
pubmed: 18456072
Women Birth. 2015 Mar;28(1):54-9
pubmed: 25457375
Semin Perinatol. 2008 Aug;32(4):307-11
pubmed: 18652933
BMC Med Res Methodol. 2006 Nov 08;6:54
pubmed: 17092344
Clin Obstet Gynecol. 2010 Sep;53(3):597-606
pubmed: 20661044
PLoS One. 2011;6(12):e28482
pubmed: 22205952
Birth. 2011 Dec;38(4):282-93
pubmed: 22112328
Int J Epidemiol. 2016 Jun;45(3):954-64
pubmed: 26686842
J Obstet Gynaecol Can. 2013 Jan;35(1):22-8
pubmed: 23343793
BJOG. 2016 May;123(6):886-98
pubmed: 26629884
Lancet. 2011 Apr 30;377(9776):1523-38
pubmed: 21496906
Lancet. 2016 Feb 13;387(10019):691-702
pubmed: 26794070
BJOG. 2011 Sep;118(10):1229-38
pubmed: 21585644
BMC Res Notes. 2010 Jan 04;3(1):2
pubmed: 20044943
Lancet. 2016 Feb 6;387(10018):574-586
pubmed: 26794077
Lancet. 2016 Feb 13;387(10019):703-16
pubmed: 26794079