Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy-the MILO Study.
Feasibility
Induction of labour
Membrane sweep
Pilot trial
Post-term
SWAT
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
02 Feb 2021
02 Feb 2021
Historique:
received:
20
05
2020
accepted:
13
01
2021
entrez:
3
2
2021
pubmed:
4
2
2021
medline:
22
6
2021
Statut:
epublish
Résumé
Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency. The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews). Multicentre, pragmatic, parallel-group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton foetus ≥ 38 weeks gestation; cephalic presentation; longitudinal lie; intact membranes; English speaking and ≥ 18 years of age will be randomised in a 2:1 ratio to membrane sweep versus no membrane sweep. Women allocated randomly to a sweep will then be randomised further (factorial component) to early (from 39 weeks) versus late (from 40 weeks) sweep commencement and a single versus weekly sweep. The proposed feasibility study consists of four work packages, i.e. (1) a multicentre, pilot randomised trial; (2) a health economic analysis; (3) a qualitative study; and (4) a study within the host trial (a SWAT). Outcomes to be collected include recruitment and retention rates, compliance with protocol, randomisation and allocation processes, attrition rates and cost-effectiveness. Focus groups will be held with women and clinicians to explore the acceptability and feasibility of the proposed intervention, study procedures and perceived barriers and enablers to recruitment. The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. Results will inform whether and how the design of the definitive trial as originally envisaged should be delivered or adapted. ClinicalTrials.gov NCT04307199 . Registered on 12 March 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency. The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews).
METHODS/DESIGN
METHODS
Multicentre, pragmatic, parallel-group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton foetus ≥ 38 weeks gestation; cephalic presentation; longitudinal lie; intact membranes; English speaking and ≥ 18 years of age will be randomised in a 2:1 ratio to membrane sweep versus no membrane sweep. Women allocated randomly to a sweep will then be randomised further (factorial component) to early (from 39 weeks) versus late (from 40 weeks) sweep commencement and a single versus weekly sweep. The proposed feasibility study consists of four work packages, i.e. (1) a multicentre, pilot randomised trial; (2) a health economic analysis; (3) a qualitative study; and (4) a study within the host trial (a SWAT). Outcomes to be collected include recruitment and retention rates, compliance with protocol, randomisation and allocation processes, attrition rates and cost-effectiveness. Focus groups will be held with women and clinicians to explore the acceptability and feasibility of the proposed intervention, study procedures and perceived barriers and enablers to recruitment.
DISCUSSION
CONCLUSIONS
The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. Results will inform whether and how the design of the definitive trial as originally envisaged should be delivered or adapted.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT04307199 . Registered on 12 March 2020.
Identifiants
pubmed: 33531062
doi: 10.1186/s13063-021-05043-9
pii: 10.1186/s13063-021-05043-9
pmc: PMC7853162
doi:
Banques de données
ClinicalTrials.gov
['NCT04307199']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
113Subventions
Organisme : Chief Scientist Office
ID : HSRU1
Pays : United Kingdom
Organisme : Health Research Board
ID : DIFA-FA-2018-005
Pays : Ireland
Références
Cochrane Database Syst Rev. 2013 Feb 28;(2):CD007707
pubmed: 23450578
Clin Infect Dis. 2014 Dec 15;59 Suppl 7:S400-7
pubmed: 25425718
JAMA. 2013 Jun 19;309(23):2445-6
pubmed: 23645117
Evid Rep Technol Assess (Full Rep). 2009 Mar;(176):1-257
pubmed: 19408970
Acta Obstet Gynecol Scand. 2008;87(2):247-9
pubmed: 18240379
Natl Vital Stat Rep. 2018 Nov;67(8):1-50
pubmed: 30707672
Cochrane Database Syst Rev. 2019 Oct 18;10:CD001233
pubmed: 31623014
Pilot Feasibility Stud. 2015 Sep 7;1:32
pubmed: 27965810
Cochrane Database Syst Rev. 2020 Aug 27;8:CD007372
pubmed: 32852803
Medsurg Nurs. 2008 Dec;17(6):411-2
pubmed: 19248407
Cochrane Database Syst Rev. 2020 Jul 15;7:CD004945
pubmed: 32666584
BMJ Open. 2014 Aug 14;4(8):e005785
pubmed: 25125480
Cochrane Database Syst Rev. 2005 Jan 25;(1):CD000451
pubmed: 15674873
BMC Med Res Methodol. 2003 Nov 24;3:26
pubmed: 14633287
BJOG. 2002 Jun;109(6):632-6
pubmed: 12118640
Health Aff (Millwood). 2011 Feb;30(2):332-9
pubmed: 21289355
Res Nurs Health. 2000 Aug;23(4):334-40
pubmed: 10940958
Obstet Gynecol. 2014 Aug;124(2 Pt 1):390-396
pubmed: 25050770
BMJ. 2016 Oct 24;355:i5239
pubmed: 27777223
Cochrane Database Syst Rev. 2014 Jun 13;(6):CD001338
pubmed: 24924489
BMC Pregnancy Childbirth. 2008 Aug 07;8:36
pubmed: 18687110
Cochrane Database Syst Rev. 2013 Jun 18;(6):CD006167
pubmed: 23780653
Cochrane Database Syst Rev. 2020 Feb 27;2:CD000451
pubmed: 32103497
J Obstet Gynaecol Can. 2017 Aug;39(8):e164-e174
pubmed: 28729108
Lancet. 2009 Jul 4;374(9683):86-9
pubmed: 19525005
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
BMJ Open. 2015 Sep 02;5(9):e008755
pubmed: 26338687
PLoS One. 2018 Apr 23;13(4):e0195951
pubmed: 29684043
Cochrane Database Syst Rev. 2018 Feb 22;2:MR000013
pubmed: 29468635