Development of a core outcome set (COS) for studies relating to awareness and clinical management of reduced fetal movement: study protocol.
Core outcome set
Pregnancy
Reduced fetal movement
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
09 Dec 2021
09 Dec 2021
Historique:
received:
05
03
2021
accepted:
17
11
2021
entrez:
10
12
2021
pubmed:
11
12
2021
medline:
15
12
2021
Statut:
epublish
Résumé
Concerns regarding reduced fetal movements (RFM) are reported in 5-15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth. Studies have aimed to improve pregnancy outcomes by evaluating interventions to raise awareness of RFM in pregnancy, such as kick counting, evaluating interventions for the clinical management of RFM, or both. However, there is not currently a core outcome set (COS) for studies of RFM. This study aims to create a COS for use in research studies that aim to raise awareness of RFM and/or evaluate interventions for the clinical management of RFM. A systematic review will be conducted, to identify outcomes used in randomised and non-randomised studies with control groups that aimed to raise awareness of RFM (for example by using mindfulness techniques, fetal movement counting, or other tools such as leaflets or mobile phone applications) and/or that evaluated the clinical management of RFM. An international Delphi consensus will then be used whereby stakeholders will rate the importance of the outcomes identified in the systematic review in (i) awareness and (ii) clinical management studies. The preliminary lists of outcomes will be discussed at a consensus meeting where one final COS for awareness and management, or two discrete COS (one for awareness and one for management), will be agreed upon. A well-developed COS will provide researchers with the minimum set of outcomes that should be measured and reported in studies that aim to quantify the effects of interventions.
Sections du résumé
BACKGROUND
BACKGROUND
Concerns regarding reduced fetal movements (RFM) are reported in 5-15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth. Studies have aimed to improve pregnancy outcomes by evaluating interventions to raise awareness of RFM in pregnancy, such as kick counting, evaluating interventions for the clinical management of RFM, or both. However, there is not currently a core outcome set (COS) for studies of RFM. This study aims to create a COS for use in research studies that aim to raise awareness of RFM and/or evaluate interventions for the clinical management of RFM.
METHODS
METHODS
A systematic review will be conducted, to identify outcomes used in randomised and non-randomised studies with control groups that aimed to raise awareness of RFM (for example by using mindfulness techniques, fetal movement counting, or other tools such as leaflets or mobile phone applications) and/or that evaluated the clinical management of RFM. An international Delphi consensus will then be used whereby stakeholders will rate the importance of the outcomes identified in the systematic review in (i) awareness and (ii) clinical management studies. The preliminary lists of outcomes will be discussed at a consensus meeting where one final COS for awareness and management, or two discrete COS (one for awareness and one for management), will be agreed upon.
DISCUSSION
CONCLUSIONS
A well-developed COS will provide researchers with the minimum set of outcomes that should be measured and reported in studies that aim to quantify the effects of interventions.
Identifiants
pubmed: 34886899
doi: 10.1186/s13063-021-05839-9
pii: 10.1186/s13063-021-05839-9
pmc: PMC8655489
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
894Subventions
Organisme : Tommy's Baby Charity
ID : R125598
Informations de copyright
© 2021. The Author(s).
Références
Lancet. 1989 Aug 12;2(8659):345-9
pubmed: 2569550
BMC Pregnancy Childbirth. 2009 Jul 22;9:32
pubmed: 19624847
Ultrasound Obstet Gynecol. 2015 Dec;46(6):641-7
pubmed: 26336941
BJOG. 2020 Jun;127(7):829-837
pubmed: 31971325
Am J Obstet Gynecol. 2019 Oct;221(4):339.e1-339.e10
pubmed: 31152710
Nurs Res. 1981 Sep-Oct;30(5):281-4
pubmed: 6912989
PLoS One. 2018 Nov 5;13(11):e0206533
pubmed: 30395584
BMC Pregnancy Childbirth. 2017 Nov 13;17(1):369
pubmed: 29132322
Arch Gynecol Obstet. 2020 Apr;301(4):987-993
pubmed: 32198623
Med Hypotheses. 2011 Jan;76(1):17-20
pubmed: 20826059
Acta Obstet Gynecol Scand. 2008;87(3):331-9
pubmed: 18307074
Trials. 2019 Jan 9;20(1):35
pubmed: 30626413
Birth. 2011 Dec;38(4):311-6
pubmed: 22112331
BMJ. 2018 Mar 6;360:k570
pubmed: 29510991
BMC Pregnancy Childbirth. 2013 Feb 05;13:32
pubmed: 23383737
PLoS One. 2012;7(6):e39259
pubmed: 22723978
Pregnancy Hypertens. 2016 Oct;6(4):274-278
pubmed: 27939467
Aust N Z J Obstet Gynaecol. 2018 Aug;58(4):463-468
pubmed: 29355899
Diabetologia. 2020 Jun;63(6):1120-1127
pubmed: 32193573
J Obstet Gynaecol. 2007 Jan;27(1):41-3
pubmed: 17365457
BMJ Open. 2018 Jul 6;8(7):e020031
pubmed: 29982198
Trials. 2017 Jun 20;18(Suppl 3):280
pubmed: 28681707