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. 2018 Mar 27;19(1):206.
doi: 10.1186/s13063-018-2581-z.

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)

Hannah L Nathan  1 , Kate Duhig  1 , Nicola Vousden  1 , Elodie Lawley  1 , Paul T Seed  1 , Jane Sandall  1 , Mrutyunjaya B Bellad  2 , Adrian C Brown  3 , Lucy C Chappell  1 , Shivaprasad S Goudar  2 , Muchabayiwa F Gidiri  4 , Andrew H Shennan  5 ; CRADLE-3 Trial Collaboration Group
Collaborators, Affiliations

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)

Hannah L Nathan et al. Trials. .

Abstract

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.

Keywords: Blood pressure; Complex intervention; Eclampsia; Hysterectomy; Maternal death; Obstetric haemorrhage; Obstetric sepsis; Pre-eclampsia; Stepped-wedge cluster-randomised controlled trial; Vital signs.

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Conflict of interest statement

Ethics approval and consent to participate

Investigators will ensure that this study is conducted in accordance with the current principles of the Declaration of Helsinki (October 2008). The conduct of this study will be in full compliance with the relevant regulations and principles of Good Clinical Practice and equivalent guidance from our trial countries. Ethical approval has been granted by the Biomedical Sciences, Dentistry, Medicine and Natural and Mathematical Sciences Research Ethics Subcommittee at King’s College London (LRS-14/15-1484). Local ethical approval from each cluster has been granted:

  1. Ethiopian Public Health Institute, Ethiopia: EPHI6.4/185

  2. K.L.E Society’s Jawaharlal Nehru Medical College, Belgaum, India: MDC/IECHSR/2015-16/A-59

  3. National Health Sciences Research Committee at Zomba Central Hospital Malawi: NHSRC 15/11/1504

  4. Office of the Sierra Leone Ethics and Scientific Review Committee Directorate of Training and Research, Connaught Hospital; Sierra Leone

  5. Uganda National Council for Science and Technology; Uganda: HS1953

  6. ERES Converge; Zambia: 20215-Aug-008

  7. Medical Research Council of Zimbabwe; Zimbabwe: MRCZ/A/1999

  8. Haiti does not have a formal ethical review process. Memorandums of understanding were drawn up with each hospital trust and a letter of support gained from the Ministry of Health

In accord with recognised procedures for stepped-wedge trials [–22], primary outcome data will be collected centrally rather than individually. Institutional-level consent is appropriate considering the following:

  1. The CRADLE intervention (i.e. vital sign measurement) will be part of standard care, is of minimal risk, and does not adversely affect the rights and welfare of the individual women

  2. The intervention is delivered at the level of the cluster, rather than the level of the individual woman. The unit of randomisation is the cluster, not the individual woman and, therefore, standard care will encompass exposure to the intervention [20]

  3. The requirement to seek consent from all pregnant/postpartum women within each trial catchment area may make the trial unfeasible, particularly considering that the individual woman will be unidentifiable by the research midwife/assistant at the point of centralised data collection

Institutional-level consent will be sought to adopt the CRADLE intervention at the start of the trial (time point zero), prior to implementation of the intervention at subsequent time points.

Informed written consent will be sought from HCP participating in interviews, focus group discussions and the evaluation of appropriateness of referrals log.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Stepped-wedge cluster-randomised controlled trial design. A schematic representation of the trial design
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure
Fig. 3
Fig. 3
Vital Signs Alert (VSA) device traffic-light early warning system display options. Legend: SBP systolic blood pressure; DBP diastolic blood pressure; SI Shock Index
See this image and copyright information in PMC

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