Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: Study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial)

Nathan, HL; Duhig, K; Vousden, N; Lawley, E; Seed, PT; Sandall, J; Bellad, MB; Brown, AC; Chappell, LC; Goudar, SS; Gidiri, MF; Shennan, AH; Hezelgrave, NL; Charantimath, U; Karadiguddi, CC; Mastiholi, SS; Mungarwadi, GM; Surur, F; Yadeta, L; Guchale, Y; Mambo, V; Chinkoyo, S; Musonda, T; Jere, C; Vwalika, B; Kopeka, M; Chima, M; Miti, J; Best, R; Clarke, M; Kamara, J; Conteh, J; Sandi, P; Sesay, M; Momodou, F; Wandabwa, J; Ditai, J; Odeke, NM; Nakimuli, A; Byamugisha, J; Namakula, D; Kalyowa, N; Birungi, D; Nakirijja, E; Hill, C; Greene, G; Vixama, A; Toussaint, P; Makonyola, G; Bukani, D; Kachinjika, M; Makwakwa, J

Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: Study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial)

Nathan, HL Duhig, K Vousden, N Lawley, E Seed, PT Sandall, J

Bellad, MB Brown, AC Chappell, LC Goudar, SS Gidiri, MF Shennan, AH Hezelgrave, NL Charantimath, U Karadiguddi, CC Mastiholi, SS Mungarwadi, GM Surur, F Yadeta, L Guchale, Y Mambo, V Chinkoyo, S Musonda, T Jere, C Vwalika, B Kopeka, M Chima, M Miti, J Best, R Clarke, M Kamara, J Conteh, J Sandi, P Sesay, M Momodou, F Wandabwa, J Ditai, J Odeke, NM Nakimuli, A Byamugisha, J Namakula, D Kalyowa, N Birungi, D Nakirijja, E Hill, C Greene, G Vixama, A Toussaint, P Makonyola, G Bukani, D Kachinjika, M Makwakwa, J

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Publication Type:: Journal Article
Citation:: Trials, 2018, 19 (1)
Issue Date:: 2018-03-27

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Field	Value	Language
dc.contributor.author	Nathan, HL	en_US
dc.contributor.author	Duhig, K	en_US
dc.contributor.author	Vousden, N	en_US
dc.contributor.author	Lawley, E	en_US
dc.contributor.author	Seed, PT	en_US
dc.contributor.author	Sandall, J https://orcid.org/0000-0003-2000-743X	en_US
dc.contributor.author	Bellad, MB	en_US
dc.contributor.author	Brown, AC	en_US
dc.contributor.author	Chappell, LC	en_US
dc.contributor.author	Goudar, SS	en_US
dc.contributor.author	Gidiri, MF	en_US
dc.contributor.author	Shennan, AH	en_US
dc.contributor.author	Hezelgrave, NL	en_US
dc.contributor.author	Charantimath, U	en_US
dc.contributor.author	Karadiguddi, CC	en_US
dc.contributor.author	Mastiholi, SS	en_US
dc.contributor.author	Mungarwadi, GM	en_US
dc.contributor.author	Surur, F	en_US
dc.contributor.author	Yadeta, L	en_US
dc.contributor.author	Guchale, Y	en_US
dc.contributor.author	Mambo, V	en_US
dc.contributor.author	Chinkoyo, S	en_US
dc.contributor.author	Musonda, T	en_US
dc.contributor.author	Jere, C	en_US
dc.contributor.author	Vwalika, B	en_US
dc.contributor.author	Kopeka, M	en_US
dc.contributor.author	Chima, M	en_US
dc.contributor.author	Miti, J	en_US
dc.contributor.author	Best, R	en_US
dc.contributor.author	Clarke, M	en_US
dc.contributor.author	Kamara, J	en_US
dc.contributor.author	Conteh, J	en_US
dc.contributor.author	Sandi, P	en_US
dc.contributor.author	Sesay, M	en_US
dc.contributor.author	Momodou, F	en_US
dc.contributor.author	Wandabwa, J	en_US
dc.contributor.author	Ditai, J	en_US
dc.contributor.author	Odeke, NM	en_US
dc.contributor.author	Nakimuli, A	en_US
dc.contributor.author	Byamugisha, J	en_US
dc.contributor.author	Namakula, D	en_US
dc.contributor.author	Kalyowa, N	en_US
dc.contributor.author	Birungi, D	en_US
dc.contributor.author	Nakirijja, E	en_US
dc.contributor.author	Hill, C	en_US
dc.contributor.author	Greene, G	en_US
dc.contributor.author	Vixama, A	en_US
dc.contributor.author	Toussaint, P	en_US
dc.contributor.author	Makonyola, G	en_US
dc.contributor.author	Bukani, D	en_US
dc.contributor.author	Kachinjika, M	en_US
dc.contributor.author	Makwakwa, J	en_US
dc.date.available	2018-03-13	en_US
dc.date.issued	2018-03-27	en_US
dc.identifier.citation	Trials, 2018, 19 (1)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/133096
dc.description.abstract	© 2018 The Author(s). Background: Obstetric haemorrhage, sepsis and pregnancy hypertension account for more than 50% of maternal deaths worldwide. Early detection and effective management of these conditions relies on vital signs. The Microlife® CRADLE Vital Sign Alert (VSA) is an easy-to-use, accurate device that measures blood pressure and pulse. It incorporates a traffic-light early warning system that alerts all levels of healthcare provider to the need for escalation of care in women with obstetric haemorrhage, sepsis or pregnancy hypertension, thereby aiding early recognition of haemodynamic instability and preventing maternal mortality and morbidity. The aim of the trial was to determine whether implementation of the CRADLE intervention (the Microlife® CRADLE VSA device and CRADLE training package) into routine maternity care in place of existing equipment will reduce a composite outcome of maternal mortality and morbidity in low- and middle-income country populations. Methods: The CRADLE-3 trial was a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care. Each cluster crossed from routine maternity care to the intervention at 2-monthly intervals over the course of 20 months (April 2016 to November 2017). All women identified as pregnant or within 6 weeks postpartum, presenting for maternity care in cluster catchment areas were eligible to participate. Primary outcome data (composite of maternal death, eclampsia and emergency hysterectomy per 10,000 deliveries) were collected at 10 clusters (Gokak, Belgaum, India; Harare, Zimbabwe; Ndola, Zambia; Lusaka, Zambia; Free Town, Sierra Leone; Mbale, Uganda; Kampala, Uganda; Cap Haitien, Haiti; South West, Malawi; Addis Ababa, Ethiopia). This trial was informed by the Medical Research Council guidance for complex interventions. A process evaluation was undertaken to evaluate implementation in each site and a cost-effectiveness evaluation will be undertaken. Discussion: All aspects of this protocol have been evaluated in a feasibility study, with subsequent optimisation of the intervention. This trial will demonstrate the potential impact of the CRADLE intervention on reducing maternal mortality and morbidity in low-resource settings. It is anticipated that the relatively low cost of the intervention and ease of integration into existing health systems will be of significant interest to local, national and international health policy-makers. Trial registration: ISCRTN41244132. Registered on 2 February 2016. Prospective protocol modifications have been recorded and were communicated to the Ethics Committees and Trials Committees. The adapted Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist and the SPIRIT Checklist are attached as Additional file 1.	en_US
dc.relation.ispartof	Trials	en_US
dc.relation.isbasedon	10.1186/s13063-018-2581-z	en_US
dc.subject.classification	Cardiovascular System & Hematology	en_US
dc.subject.classification	General & Internal Medicine	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Hypertension, Pregnancy-Induced	en_US
dc.subject.mesh	Shock, Cardiogenic	en_US
dc.subject.mesh	Blood Pressure Determination	en_US
dc.subject.mesh	Treatment Outcome	en_US
dc.subject.mesh	Maternal Mortality	en_US
dc.subject.mesh	Risk Factors	en_US
dc.subject.mesh	Predictive Value of Tests	en_US
dc.subject.mesh	Equipment Design	en_US
dc.subject.mesh	Pregnancy	en_US
dc.subject.mesh	Blood Pressure	en_US
dc.subject.mesh	Developing Countries	en_US
dc.subject.mesh	Cost-Benefit Analysis	en_US
dc.subject.mesh	Health Care Costs	en_US
dc.subject.mesh	Africa	en_US
dc.subject.mesh	Haiti	en_US
dc.subject.mesh	India	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Multicenter Studies as Topic	en_US
dc.subject.mesh	Clinical Alarms	en_US
dc.subject.mesh	Pragmatic Clinical Trials as Topic	en_US
dc.title	Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: Study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial)	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	19	en_US
utslib.for	1114 Paediatrics and Reproductive Medicine	en_US
utslib.for	1102 Cardiorespiratory Medicine and Haematology	en_US
utslib.for	1103 Clinical Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Midwifery
utslib.copyright.status	open_access
pubs.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	19	en_US

Abstract:

© 2018 The Author(s). Background: Obstetric haemorrhage, sepsis and pregnancy hypertension account for more than 50% of maternal deaths worldwide. Early detection and effective management of these conditions relies on vital signs. The Microlife® CRADLE Vital Sign Alert (VSA) is an easy-to-use, accurate device that measures blood pressure and pulse. It incorporates a traffic-light early warning system that alerts all levels of healthcare provider to the need for escalation of care in women with obstetric haemorrhage, sepsis or pregnancy hypertension, thereby aiding early recognition of haemodynamic instability and preventing maternal mortality and morbidity. The aim of the trial was to determine whether implementation of the CRADLE intervention (the Microlife® CRADLE VSA device and CRADLE training package) into routine maternity care in place of existing equipment will reduce a composite outcome of maternal mortality and morbidity in low- and middle-income country populations. Methods: The CRADLE-3 trial was a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care. Each cluster crossed from routine maternity care to the intervention at 2-monthly intervals over the course of 20 months (April 2016 to November 2017). All women identified as pregnant or within 6 weeks postpartum, presenting for maternity care in cluster catchment areas were eligible to participate. Primary outcome data (composite of maternal death, eclampsia and emergency hysterectomy per 10,000 deliveries) were collected at 10 clusters (Gokak, Belgaum, India; Harare, Zimbabwe; Ndola, Zambia; Lusaka, Zambia; Free Town, Sierra Leone; Mbale, Uganda; Kampala, Uganda; Cap Haitien, Haiti; South West, Malawi; Addis Ababa, Ethiopia). This trial was informed by the Medical Research Council guidance for complex interventions. A process evaluation was undertaken to evaluate implementation in each site and a cost-effectiveness evaluation will be undertaken. Discussion: All aspects of this protocol have been evaluated in a feasibility study, with subsequent optimisation of the intervention. This trial will demonstrate the potential impact of the CRADLE intervention on reducing maternal mortality and morbidity in low-resource settings. It is anticipated that the relatively low cost of the intervention and ease of integration into existing health systems will be of significant interest to local, national and international health policy-makers. Trial registration: ISCRTN41244132. Registered on 2 February 2016. Prospective protocol modifications have been recorded and were communicated to the Ethics Committees and Trials Committees. The adapted Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist and the SPIRIT Checklist are attached as Additional file 1.

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http://hdl.handle.net/10453/133096