Microlife Cradle VSA (BP 3GP1-1L)
The Microlife Cradle VSA (BP 3GP1-1L) is included in a current validation and equivalence audit, by Medaval, in preparation for (EU) 2017/745. Validation details will be posted when this has been completed.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | Audit | Validation under audit | ||
| ESH (Europe) | Professional use for pregnancy | A validation, without a reference, which Medaval is unable to identify. | ||
Nathan HL, Duhig K, Vousden N, Lawley E, Seed PT, Sandall J, Bellad MB, Brown AC, Chappell LC, Goudar SS, Gidiri MF, Shennan AH; CRADLE-3 Trial Collaboration Group. 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). Trials. 2018 Mar 27;19(1):206. doi: 10.1186/s13063-018-2581-z. PMID: 29587875. Available from: trialsjournal.biomedcentral.com.
The CRADLE-3 Trial will demonstrate the potential impact of the CRADLE intervention, following protocol evaluation in a feasibility study, with subsequent optimisation, on reducing maternal mortality and morbidity in low-resource settings.
Vousden N, Lawley E, Nathan HL, Seed PT, Brown A, Muchengwa T, Charantimath U, Bellad M, Gidiri MF, Goudar S, Chappell LC, Sandall J, Shennan AH; CRADLE Trial Collaborative Group. Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial. BMC Pregnancy Childbirth. 2018 Apr 27;18(1):115. doi: 10.1186/s12884-018-1737-x. PMID: 29703254. Available from: PMC5924508.
This feasibility study concluded that the components of the intervention were acceptable, methods of implementing were successful and the main CRADLE-3 trial design would be feasible.
Nathan HL, Duhig K, Vousden N, Lawley E, Seed PT, Sandall J, Bellad MB, Brown AC, Chappell LC, Goudar SS, Gidiri MF, Shennan AH; CRADLE-3 Trial Collaboration Group. 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). Trials. 2018 Mar 27;19(1):206. doi: 10.1186/s13063-018-2581-z. PMID: 29587875. Available from: trialsjournal.biomedcentral.com.
The CRADLE-3 Trial will demonstrate the potential impact of the CRADLE intervention, following protocol evaluation in a feasibility study, with subsequent optimisation, on reducing maternal mortality and morbidity in low-resource settings.
Nathan HL, Duhig K, Vousden N, Lawley E, Seed PT, Sandall J, Bellad MB, Brown AC, Chappell LC, Goudar SS, Gidiri MF, Shennan AH; CRADLE-3 Trial Collaboration Group. 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). Trials. 2018 Mar 27;19(1):206. doi: 10.1186/s13063-018-2581-z. PMID: 29587875. Available from: trialsjournal.biomedcentral.com.
The CRADLE-3 Trial will demonstrate the potential impact of the CRADLE intervention, following protocol evaluation in a feasibility study, with subsequent optimisation, on reducing maternal mortality and morbidity in low-resource settings.
