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Cited by 8Health Policy Implementation ScienceGlobal Maternal and Child HealthMaternal and fetal healthcare

CRADLE-5: a stepped-wedge type 2 hybrid implementation-effectiveness cluster randomised controlled trial to evaluate the real-world scale-up of the CRADLE Vital Signs Alert intervention into routine maternity care in Sierra Leone—study protocol

Open access
Ridout, Alexandra E., Moses, Francis L., Herm-Singh, Simren, Turienzo, Cristina Fernandez, Seed, Paul T., Goodhart, Venetia, Vousden, Nicola, Sam, Betty +13 more·2023·Trials
DOI 10.1186/s13063-023-07587-4PMC PMC10506317
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Abstract

Background: The CRADLE Vital Signs Alert intervention (an accurate easy-to-use device that measures blood pressure and pulse with inbuilt traffic-light early warning system, and focused training package) was associated with reduced rates of eclampsia and maternal death when trialled in urban areas in Sierra Leone. Subsequently, implementation was successfully piloted as evidenced by measures of fidelity, feasibility and adoption. The CRADLE-5 trial will examine whether national scale-up, including in the most rural areas, will reduce a composite outcome of maternal and fetal mortality and maternal morbidity and will evaluate how the CRADLE package can be embedded sustainably into routine clinical pathways. Methods: CRADLE-5 is a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care across eight rural districts in Sierra Leone (Bonthe, Falaba, Karene, Kailahun, Koinadugu, Kono, Moyamba, Tonkolili). Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023). All women identified as pregnant or within six-weeks postpartum presenting for maternity care in the district are included. Primary outcome data (composite rate of maternal death, stillbirth, eclampsia and emergency hysterectomy) will be collected. A mixed-methods process and scale-up evaluation (informed by Medical Research Council guidance for complex interventions and the World Health Organization ExpandNet tools) will explore implementation outcomes of fidelity, adoption, adaptation and scale-up outcomes of reach, maintenance, sustainability and integration. Mechanisms of change and contextual factors (barriers and facilitators) will be assessed. A concurrent cost-effectiveness analysis will be undertaken. Discussion: International guidance recommends that all pregnant and postpartum women have regular blood pressure assessment, and healthcare staff are adequately trained to respond to abnormalities. Clinical effectiveness to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability of the CRADLE intervention at scale has yet to be investigated. This trial will explore whether national scale-up of the CRADLE intervention reduces maternal and fetal mortality and severe maternal adverse outcomes and understand the strategies for adoption, integration and sustainability in low-resource settings. If successful, the aim is to develop an adaptable, evidence-based scale-up roadmap to improve maternal and infant outcomes. Trial registration: ISRCTN 94429427. Registered on 20 April 2022.

AI snapshot

Written from the paper’s full text.

TL;DR

CRADLE-5 is a stepped-wedge type 2 hybrid implementation-effectiveness cluster randomised controlled trial protocol evaluating national scale-up of the CRADLE Vital Signs Alert intervention in eight rural districts of Sierra Leone. It aims to test whether scale-up reduces a composite of maternal and fetal mortality and severe maternal morbidity while assessing implementation, scale-up, sustainability, and cost-effectiveness.

Key findings

  • The trial’s primary objective is to determine whether real-world scale-up of the CRADLE VSA device and focused education package is sustainably adopted and reduces a composite of all-cause maternal mortality or major morbidity and fetal loss by ≥ 20%.
  • Prior CRADLE-3 evidence in Freetown, Sierra Leone, reported a 40% reduction in the primary composite outcome (OR 0.60, 95% CI 0.50–0.72, p < 0.001) and a 60% reduction in maternal death (RR 0.37, 95% CI 0.25–0.55, p < 0.0001).
  • A prior pilot across eight districts trained 160 CRADLE Champions and 40 Master Trainers, distributed 2800 CRADLE devices and 1200 large cuffs, reached 716 peripheral health unit facilities, and rolled out to 2031 frontline healthcare staff, showing high feasibility and acceptability.
  • The trial includes a mixed-methods process and scale-up evaluation of fidelity, adoption, adaptation, reach, maintenance, sustainability, and integration, plus a concurrent cost-effectiveness analysis.

Methods

  • Pragmatic, mixed-methods, multi-district stepped-wedge cluster randomised controlled trial across eight rural Sierra Leone districts: Bonthe, Falaba, Karene, Kailahun, Koinadugu, Kono, Moyamba, and Tonkolili. Each district crosses from control to intervention at six-weekly intervals over 1 year (May 2022 to June 2023); outcomes from 23 May 2022 to 1 January 2024 will be analysed.
  • Participants are all women identified as pregnant or within the 6-week postpartum period presenting for antenatal, intrapartum, or postpartum care in the district during the trial timeframe; there are no exclusion criteria. The intervention is the CRADLE VSA device plus CRADLE training package delivered via a train-the-trainer model.
  • Primary outcome is a composite of maternal death, eclampsia, emergency hysterectomy, and stillbirth, assessed from district/referral hospitals and the highest-level peripheral health units (20% sample). Analysis uses a non-parametric within-period Monte Carlo permutation method for stepped-wedge designs, with binomial log-link regression estimating risk ratios, fixed effects for regional linear trends, 95% CIs, and p < 0.05; secondary outcomes use multilevel logistic regression. Sample size assumes up to 1000 deliveries per district per six weeks, event rate falling from 5% to 4%, and with CAC = 1 power is close to 100% even with ICC 0.5.

Limitations

  • The paper states potential limitations include capacity and engagement of district medical teams to coordinate and deliver sufficient staff refresher training amid multiple active healthcare initiatives, and technical issues with the CRADLE device such as charging and broken parts, which could limit sustainable integration and impact.
  • Evident from the text: blinding of women and healthcare providers is not possible, though study assignment is masked to the statistician and data analysts. Primary outcome data are limited to district/referral hospitals and the top 20% of peripheral health units; outcomes occurring elsewhere are not included.
  • Evident from the text: no subgroup analyses are possible because detailed information on total deliveries by age or parity cannot be collected, and no data monitoring committee or interim analysis stopping rule will be used given the low-risk intervention.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1186/s13063-023-07587-4

Cites

27 of 27 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 39 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    Feasibility data suggests the cluster autocorrelation coefficient (CAC) is likely to be 1.

    “Feasibility data suggests the CAC is likely to be 1.”
    Quote in the paperNot a substantial claim
  • Premisecitation

    The CRADLE VSA device has been validated as accurate for use in women who develop low blood pressure from sepsis or haemorrhage.

    “The device has additionally been validated as accurate for use in women with preeclampsia [12] and in those who develop low BP from sepsis or haemorrhage [13].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [13] Nathan HL, De Greeff A, Hezelgrave NL, Chappell LC, Shennan AH. Accuracy validation of the Microlife 3AS1-2 blood pressure device in a pregnant population with low blood pressure. Blood Press Monit. 2015;20(5):299–302. source

      Not checked in the free run.

  • Study design and conductown data

    With a CAC of 1, power will be more than adequate with 1000 women per month per centre.

    “As per Fig. 3, with a CAC of 1, power will be more than adequate with 1000 women per month per centre.”
    Quote in the paperSubstantial claim
  • Study design and conductnone given

    The unit of randomisation in the trial is the cluster (a district), rather than individual women.

    “The unit of randomisation in our trial is the cluster (a district), rather than individual women.”
    Quote in the paperSubstantial claim
  • Premisecitation

    The CRADLE VSA device fulfils the World Health Organization requirements for low-resource settings.

    “The device fulfils the World Health Organization requirements for low-resource settings [24].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [24] De Greeff A, Nathan H, Stafford N, Liu B, Shennan AH. Development of an accurate oscillometric blood pressure device for low resource settings. Blood Press Monit. 2008;13(6):342–8. source

      Not checked in the free run.

  • Classified as probably not a substantial claim. 46
  • May combine two claims. 39

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    In Sierra Leone, the maternal mortality ratio decreased from 1165 per 100,000 in 2013 to 717 per 100,000 live births in 2019.

    “Despite an almost 40% reduction in the maternal mortality ratio (MMR) from 1165 per 100,000 in 2013 to 717 per 100,000 live births in 2019 [2], SL still has one of the highest MMR in the world.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [2] Statistics Sierra Leone Stats SL and ICF. Sierra Leone demographic and health survey 2019. Freetown and Rockville: Stats SL and ICF; 2020. Available from: https://www.dhsprogram.com/pubs/pdf/FR365/FR365.pdf.

      Not checked in the free run.

  • May combine two claims.

    Premiseown data

    The pilot rollout reached 716 peripheral health unit facilities providing maternity care and rolled out to 2031 frontline healthcare staff.

    “The rollout reached 716 peripheral health unit (PHU) facilities providing maternity care, and rolled out to 2031 frontline healthcare staff, showing high levels of feasibility and acceptability.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Infants whose mothers die are up to ten times more likely to die within the first two years of life.

    “Infants whose mothers die are up to ten times more likely to die within the first two years of life [5].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] Naz L, Patel KK. Determinants of infant mortality in Sierra Leone: applying Cox proportional hazards model. Int J Soc Econ. 2020;47(6):711–26. source

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    Strong acceptance from frontline healthcare staff and robust evidence prompted buy-in and advocacy by the MoHS in Sierra Leone for horizontal scale-up of the CRADLE intervention to the rest of the country.

    “Strong acceptance from frontline healthcare staff and robust evidence prompted buy-in and advocacy by the MoHS in Sierra Leone for horizontal scale-up of the CRADLE intervention to the rest of the country (Fig. 1).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Two offline mobile phone applications were developed to aid primary outcome and process evaluation data collection; both have integrated GPS geotagging capabilities allowing real time monitoring of data collection and CRADLE training adherence.

    “Two offline mobile phone applications were developed to aid primary outcome and process evaluation data collection; both have integrated Global Positioning System (GPS) geotagging capabilities allowing real time monitoring of data collection and CRADLE training adherence.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premiseown data

    In the Sierra Leone pilot of CRADLE across eight districts between March 2020 and January 2021, 160 CRADLE Champions and 40 Master Trainers were trained, and 2800 CRADLE devices and 1200 large cuffs distributed.

    “Full results will be published separately, but in summary, 160 CRADLE Champions and 40 Master Trainers were trained, and 2800 CRADLE devices and 1200 large cuffs distributed.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Two clusters, Falaba and Bonthe, were paired before randomisation.

    “Two clusters, Falaba and Bonthe, were paired before randomisation.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductcitation

    Sample size estimation was provided by the CRADLE senior statistician using Stata version 13.1 and the methods of Hemming and Girling.

    “Sample size estimation has been provided by the CRADLE senior statistician, using Stata version 13.1 and the methods of Hemming and Girling [28].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Hemming and Girling [28] Hemming K, Girling A. A menu-driven facility for power and detectable-difference calculations in stepped-wedge cluster-randomized trials. Stata J. 2014;14(2):363–80. source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisenone given

    Sample size calculations for longitudinal cluster randomised trials necessitate estimation of the correlation structure (within-period ICC and CAC).

    “Sample size calculations for longitudinal cluster randomised trials, such as our proposed stepped-wedge trials, necessitate the estimation of the correlation structure underlying the study.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationreasoning

    Extreme preterm delivery to reduce maternal morbidity and mortality from preeclampsia/eclampsia may result in an increase in neonatal mortality.

    “Conversely, extreme preterm delivery to reduce maternal morbidity and mortality from preeclampsia/eclampsia may result in an increase in neonatal mortality.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    The trial was preceded by a feasibility phase in which the eight main trial districts collected primary outcome data to evaluate the methods of data collection and to inform the randomisation programme and sample size calculation.

    “The trial was preceded by a feasibility phase. The eight main trial districts collected primary outcome data to evaluate the methods of data collection and to inform the randomisation programme and sample size calculation.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Institutional-level consent and relevant local approvals from district health authorities and hospitals on behalf of the cluster will be obtained at the start of the trial (time point zero), prior to implementation of the intervention at subsequent time points.

    “In accordance with recognised procedures for stepped-wedge cluster trials [18], institutional-level consent and relevant local approvals from district health authorities and hospitals on behalf of the cluster will be obtained at the start of the trial (time point zero), prior to implementation of the intervention at subsequent time points.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [18] Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, et al. Reporting of stepped wedge cluster randomised trials: extension of the consort 2010 statement with explanation and elaboration. BMJ. 2018;363:k1614. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductnone given

    The nature of the CRADLE intervention is such that blinding of women and healthcare providers cannot be achieved.

    “The nature of the CRADLE intervention is such that blinding of women and healthcare providers cannot be achieved.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Three-monthly monitoring trips are undertaken to supervise, monitor and audit data collection of primary and secondary outcomes, in addition to real time online data monitoring.

    “Three-monthly monitoring trips are undertaken to supervise, monitor and audit data collection of primary and secondary outcomes, in addition to real time online data monitoring.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    The districts will be masked until they are informed of their allocation four to six weeks prior to their implementation date.

    “The districts will be masked until they are informed of their allocation four to six weeks prior to their implementation date to give sufficient time for training and distribution of devices to be arranged.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductcitation

    The CRADLE-5 trial is a pragmatic, mixed-methods, multi-district, stepped-wedge cluster-randomised controlled trial of the scale-up of the CRADLE intervention into routine maternity care settings in Sierra Leone.

    “The CRADLE-5 trial is a pragmatic, mixed-methods, multi-district, stepped-wedge cluster-randomised controlled trial of the scale-up of the CRADLE intervention (CRADLE VSA device and CRADLE training package) into routine maternity care settings in SL and will be reported in line with the CONSORT stepped wedge cluster randomised trials update [18].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [18] Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, et al. Reporting of stepped wedge cluster randomised trials: extension of the consort 2010 statement with explanation and elaboration. BMJ. 2018;363:k1614. source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    The CRADLE VSA device has undergone extensive testing for accuracy and is one of few blood pressure devices validated as accurate in pregnancy (including pre-eclampsia and hypotension) and in non-pregnant adults.

    “The device has undergone extensive testing for accuracy and is one of few BP devices to have been validated as accurate in pregnancy (including pre-eclampsia and hypotension) and in non-pregnant adults [11, 23, 24].”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [11] Nathan HL, Vousden N, Lawley E, de Greeff A, Hezelgrave NL, Sloan N, et al. Development and evaluation of a novel Vital Signs Alert device for use in pregnancy in low-resource settings. BMJ Innov. 2018;4(4):192–8. Available from: http://innovations.bmj.com/lookup/doi/10.1136/bmjinnov-2017-000235. source

      Not checked in the free run.

    • cites [23] Nathan HL, Seed PT, Hezelgrave NL, De Greeff A, Lawley E, Anthony J, et al. Early warning system hypertension thresholds to predict adverse outcomes in pre-eclampsia: a prospective cohort study. Pregnancy Hypertens. 2018;12:183–8. source

      Not checked in the free run.

    • cites [24] De Greeff A, Nathan H, Stafford N, Liu B, Shennan AH. Development of an accurate oscillometric blood pressure device for low resource settings. Blood Press Monit. 2008;13(6):342–8. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    This is a pragmatic trial and any deviation from the implementation plan will be recorded.

    “This is a pragmatic trial and any deviation from the implementation plan will be recorded.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Sierra Leone still has one of the highest maternal mortality ratios in the world.

    “Despite an almost 40% reduction in the maternal mortality ratio (MMR) from 1165 per 100,000 in 2013 to 717 per 100,000 live births in 2019 [2], SL still has one of the highest MMR in the world.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [2] Statistics Sierra Leone Stats SL and ICF. Sierra Leone demographic and health survey 2019. Freetown and Rockville: Stats SL and ICF; 2020. Available from: https://www.dhsprogram.com/pubs/pdf/FR365/FR365.pdf.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Perinatal mortality in Sierra Leone is 34 per 1000 live births, with a stillbirth rate of 24 per 1000 live births.

    “Perinatal mortality is high (34 per 1000 live births), with a stillbirth rate of 24 per 1000 live births [3].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [3] UNICEF. Maternal and newborn health disparities, Sierra Leone. 2022. Available from: https://reliefweb.int/sites/reliefweb.int/files/resources/SLE_country%20profile.pdf.

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023).

    “Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    The pilot showed high levels of feasibility and acceptability.

    “The rollout reached 716 peripheral health unit (PHU) facilities providing maternity care, and rolled out to 2031 frontline healthcare staff, showing high levels of feasibility and acceptability.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    The districts will first be allocated random area numbers, and the sequence of timing for receiving the CRADLE intervention will then be determined by computer-generated random numbers by the CRADLE statistician.

    “The districts will first be allocated random area numbers, and the sequence of timing for receiving the CRADLE intervention will then be determined by computer-generated random numbers by the CRADLE statistician.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Teenage mothers in Sierra Leone have a 40 to 60 percent higher risk of maternal death.

    “One in thirty-one women die during childbirth [3], with a 40 to 60 percent higher risk for teenage mothers [4].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [4] Bash-Taqi R, Watson K, Akwara E, Adebayo E, Chandra-Mouli V. From commitment to implementation: lessons learnt from the first National Strategy for the Reduction of Teenage Pregnancy in Sierra Leone. Sex Reprod Health Matters. 2020;28(1):408–22. https://doi.org/10.1080/26410397.2020.1818376. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    In Sierra Leone, one in thirty-one women die during childbirth.

    “One in thirty-one women die during childbirth [3], with a 40 to 60 percent higher risk for teenage mothers [4].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [3] UNICEF. Maternal and newborn health disparities, Sierra Leone. 2022. Available from: https://reliefweb.int/sites/reliefweb.int/files/resources/SLE_country%20profile.pdf.

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisecitation

    In Sierra Leone, 76% of maternal deaths are caused by haemorrhage, hypertension and sepsis.

    “Data from the CRADLE-3 trial [6] correlate with national statistics; 76% of maternal deaths are caused by haemorrhage, hypertension and sepsis [7]; all of which are marked by abnormalities in blood pressure (BP) and heart rate (HR).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [7] Coathup V, Boyle E, Carson C, Johnson S, Kurinzcuk JJ, Macfarlane A, et al. Gestational age and hospital admissions during childhood: population based, record linkage study in England ( TIGAR study ). BMJ. 2020;371:4075. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Interpretationreasoning

    The CRADLE intervention should enable healthcare professionals to recognise abnormal vital signs earlier and manage complications in a timelier manner.

    “The CRADLE intervention should enable healthcare professionals to recognise abnormal vital signs earlier and manage complications in a timelier manner, with the management of severely compromised pregnant women potentially requiring transfer to higher-level centres for specialist treatment.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    The CRADLE VSA device is a hand-held, semi-automated, low-cost blood pressure and heart rate measuring device with a built-in traffic-light warning system developed for use in low-income settings.

    “The CRADLE Vital Sign Alert (VSA) device is a hand-held, semi-automated, low-cost BP and HR measuring device with a built-in traffic-light warning system that has been especially developed for use in low-income settings during pregnancy and the postpartum period [11].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [11] Nathan HL, Vousden N, Lawley E, de Greeff A, Hezelgrave NL, Sloan N, et al. Development and evaluation of a novel Vital Signs Alert device for use in pregnancy in low-resource settings. BMJ Innov. 2018;4(4):192–8. Available from: http://innovations.bmj.com/lookup/doi/10.1136/bmjinnov-2017-000235. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Interpretationreasoning

    The remaining eight districts are rural and provide the opportunity to evaluate the impact of CRADLE in this setting, where appropriate triage and referral may have greater impact on outcomes.

    “The remaining eight districts are rural and provide the opportunity to evaluate the impact of CRADLE in this setting, where appropriate triage and referral may have greater impact on outcomes.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    The intervention is delivered at the level of the district, rather than the individual woman, and standard care will encompass exposure to the intervention.

    “The intervention is delivered at the level of the district, rather than the level of the individual woman, and standard care will encompass exposure to the intervention [18].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [18] Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, et al. Reporting of stepped wedge cluster randomised trials: extension of the consort 2010 statement with explanation and elaboration. BMJ. 2018;363:k1614. source

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    One district will be randomly allocated to receive the intervention at time point 1, whilst all the remaining areas contribute to the control at this time point; a second district is randomly allocated to the intervention at time point 2 and so on.

    “One district will be randomly allocated to receive the intervention at time point 1, whilst all the remaining areas contribute to the control at this time point. A second district is randomly allocated to the intervention at time point 2 and so on.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Interpretationnone given

    Earlier recognition of pregnancy hypertension during antenatal care should facilitate appropriate timing of delivery and reduction in preventable stillbirth and neonatal morbidity and mortality as a complication of preeclampsia and eclampsia.

    “Earlier recognition of pregnancy hypertension during antenatal care should facilitate appropriate timing of delivery and reduction in preventable stillbirth and neonatal morbidity and mortality as a complication of preeclampsia and eclampsia.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Study assignment will be masked to the CRADLE statistician and the researchers who will analyse the data.

    “However, study assignment will be masked to the CRADLE statistician and the researchers who will analyse the data.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Premisereasoning

    A combination of both quantitative and qualitative data is needed to answer the study's research questions.

    “A combination of both quantitative and qualitative data will be needed to answer our research questions.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S4 (based). May combine two claims.

    Interpretationreasoning

    Normal vital signs should reassure clinicians and reduce inappropriate referrals.

    “Normal vital signs should reassure clinicians and reduce inappropriate referrals.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    Based on the pilot within the first eight districts, the CRADLE training was refined to include a more in-depth focus on emergency obstetric and newborn care (EmONC), increased community engagement to facilitate patient referral acceptance by stakeholders and increased hospital engagement to support adoption of the CRADLE intervention across multi-disciplinary teams and cadres.

    “Based on the pilot within the first eight districts, the CRADLE training was refined to include a more in-depth focus on emergency obstetric and newborn care (EmONC), increased community engagement to facilitate patient referral acceptance by stakeholders and increased hospital engagement to support adoption of the CRADLE intervention across multi-disciplinary teams and cadres.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    There are disparities in access to vital sign assessment and skilled intervention, and delays in delivery and escalation of care, varying by geographical area and socio-demographic characteristics.

    “However, there are often disparities in access to vital sign assessment and skilled intervention, and delays in delivery and escalation of care [9, 10], varying by geographical area and socio-demographic characteristics.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [9] Bright S, Moses F, Ridout A, Sam B, Momoh M, Goodhart V, et al. Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption. Reprod Health. 2023;20(1):1–11. https://doi.org/10.1186/s12978-022-01551-2. source

      Not checked in the free run.

    • cites [10] Ministry of Health and Sanitation (Sierra Leone). Summary report of the 2017 SARA plus in Sierra Leone: service availability and readiness assessment, quality of care survey and data quality review. Sara plus Rep. 2017. Available from: https://mohs2017.files.wordpress.com/2018/05/mohs-sierra-leone_sara-report_final.pdf.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The CRADLE-5 trial management team will perform validation checks to verify validity and completeness of data.

    “The CRADLE-5 trial management team will perform a number of validation checks to verify validity and completeness.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.

    Premisenone given

    All primary outcomes are robust and meaningful clinical endpoints that are unambiguous and therefore feasible to collect.

    “All primary outcomes are robust and meaningful clinical endpoints that are unambiguous and therefore feasible to collect.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

    Premisereasoning

    Blood pressure and pulse measurement is standard practice as a screening tool in antenatal care and therefore no adverse events or harms are expected.

    “Blood pressure and pulse measurement is standard practice as a screening tool in antenatal care and therefore no adverse events or harms are expected.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    The effect of the intervention on primary and secondary outcomes will be analysed using multilevel logistic regression with random effects of centre and adjustments for fixed categorical effects of time.

    “The effect of the intervention on primary and secondary outcomes will be analysed using multilevel logistic regression with random effects of centre and adjustments for fixed categorical effects of time.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    The trial is not blinded; therefore, there is no unblinding procedure.

    “The trial is not blinded; therefore, there is no unblinding procedure.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The trial opened on 23 May 2022; all outcomes occurring from 23 May 2022 to 1 January 2024 will be included in the analysis.

    “The trial opened on the 23 May 2022; all outcomes occurring from 23 May 2022 to 1 January 2024 will be included in the analysis.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The trial received ethical approval from the Office of the Sierra Leone Ethics and Scientific Review Committee on 24th January 2022 and from the King's College London, UK Research Ethic Committee on 27 January 2022.

    “The trial received ethical approval from the Office of the Sierra Leone Ethics and Scientific Review Committee on 24th January 2022 and from the King’s College London, UK Research Ethic Committee on 27 January 2022.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    There are no additional plans for auditing trial conduct apart from those described in other sections.

    “There are no additional plans for auditing trial conduct apart from those described in other sections.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    Three quarters of maternal deaths in Sierra Leone are caused by haemorrhage, hypertension and sepsis, all of which cause abnormalities in vital signs.

    “Three quarters of maternal deaths in SL are caused by haemorrhage, hypertension and sepsis [6], all of which cause abnormalities in vital signs.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [6] Vousden N, Lawley E, Nathan HL, Seed PT, Gidiri MF, Goudar S, et al. Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial. Lancet Glob Health. 2019;7(3):e347–56. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Potential limitations include capacity and engagement of district medical teams to coordinate and deliver sufficient staff refresher training, given multiple active healthcare initiatives across the country, and technical issues related to the CRADLE device (charging and broken parts), which could limit sustainable integration and impact.

    “include capacity and engagement of district medical teams to coordinate and deliver sufficient staff refresher training, given multiple active healthcare initiatives across the country, and technical issues related to the CRADLE device, i.e. charging and broken parts, which could limit sustainable integration and impact.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductcitation

    For the primary analysis, a new approach described by Thompson et al. will be used.

    “For our primary analysis method, we will use a new approach described by Thompson et al. [31, 32].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Thompson et al. [31, 32]

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    This is a type 2 hybrid implementation-effectiveness cluster randomised controlled trial in a stepped-wedge design that will allow simultaneous testing of the clinical intervention and the effectiveness of the implementation strategy.

    “This is a type 2 hybrid implementation-effectiveness cluster randomised controlled trial in a stepped-wedge design that will allow us to simultaneously test our clinical intervention in the form of the CRADLE device and the effectiveness of our implementation strategy. This design is based on those described by Hussey and Hughes [29] and Curran et al. [30].”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites Hussey and Hughes [29] Hussey MA, Hughes J. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–91. source

      Not checked in the free run.

    • cites Curran et al. [30] Curran GM, Bauer M, Mittman B, Pyne JMSC. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–26. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    Given the low risks of the CRADLE-5 intervention and the unlikelihood of critical safety concerns directly related to implementing the intervention, the trial will not have a data monitoring committee nor interim analysis stopping rule.

    “Given the low risks of the CRADLE-5 intervention and the unlikelihood of critical safety concerns directly related to implementing the intervention, the trial will not have a data monitoring committees nor interim analysis stopping rule.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

    Premisenone given

    The intervention has been tailored for delivery to rural populations, who are amongst the most vulnerable in terms of access to healthcare, with the worst outcomes.

    “In summary, this intervention has been tailored for delivery to rural populations, who are amongst the most vulnerable, in terms of access to healthcare, with the worst outcomes.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductreasoning

    Detailed information on the total number of deliveries in each district (e.g., breakdown by age or parity) will not be collected, so no subgroup analysis will be possible.

    “We will not be able to collect detailed information (for example breakdown by age or parity) on the total number of deliveries in each district so no subgroup analysis will be possible.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    All analyses will adhere to the intention-to-treat principle, meaning subjects will be analysed based on the treatment option they were assigned to at the centre when the event occurred.

    “All analyses will adhere to the intention-to-treat principle, meaning that subjects will be analysed based on the treatment option they were assigned to at the centre when the event occurred.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    No additional analyses based on the per-protocol principle will be conducted.

    “No additional analyses based on the per-protocol principle will be conducted.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisereasoning

    Strong stakeholder buy-in, achieved through long-term engagement, theory of change workshops and a policy lab, has led to integration of CRADLE into other programmes and initiatives including the National EmONC training package and the train-the-trainer methodology.

    “Strong stakeholder buy-in, achieved through long-term engagement, theory of change workshops and a policy lab has led to integration of CRADLE into other programmes and initiatives including the National EmONC training package and the ‘train-the-trainer methodology galvanises local teams to take ownership at both district and community level.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    The method is robust to how the correlation structure is specified, so further allowances for the data structure as used in multi-level modelling are not needed.

    “As the method is robust to how the correlation structure is specified, further allowances for the data structure, as used in multi-level modelling, are not needed.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Thompson et al. [31, 32]

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Training in the trial protocol will be delivered to teams centrally and on site to ensure staff are confident and competent to collect outcome data and ensure quality, accuracy and completeness.

    “Training in the trial protocol will be delivered to teams centrally (before recruitment begins) and on site in the field, to ensure staff are confident and competent to collect outcome data and quality, accuracy and completeness of data collection is ensured.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Twenty-five per cent of hospital source data will be validated by the central CRADLE team, reviewed bi-monthly to check for transcription errors.

    “Twenty-five per cent of hospital source data will be validated by the central CRADLE team, and this will be reviewed bi-monthly during the visits by the programme manager and/or research assistant to each of the trial areas, to check for transcription errors.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    In addition, the analysis will adjust for the availability of six common drugs: MgSO4, ampicillin, gentamycin, metronidazole, oxytocin, and misoprostol, varying with time and district.

    “In addition, we will adjust for the availability of six common drugs: magnesium sulphate (MgSO4), ampicillin, gentamycin, metronidazole, oxytocin, and misoprostol, varying with time and district.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    This trial design has a strong, context specific evidence base, with substantial pilot and feasibility work, and is underpinned by several sustained collaborative partnerships in Sierra Leone, including with the MoHS.

    “However, this trial design has a strong, context specific evidence base [6, 9], with substantial pilot and feasibility work, and is underpinned by several sustained collaborative partnerships in Sierra Leone, including with the MoHS.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [6] Vousden N, Lawley E, Nathan HL, Seed PT, Gidiri MF, Goudar S, et al. Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial. Lancet Glob Health. 2019;7(3):e347–56. source

      Not checked in the free run.

    • cites [9] Bright S, Moses F, Ridout A, Sam B, Momoh M, Goodhart V, et al. Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption. Reprod Health. 2023;20(1):1–11. https://doi.org/10.1186/s12978-022-01551-2. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.

    Premisereasoning

    The trial protocol was developed with strong and enthusiastic in-country advocacy, with top-down and bottom-up involvement and resultant widespread acceptance of the intervention.

    “The trial protocol was developed with strong and enthusiastic in-country advocacy, with top-down and bottom-up involvement and resultant widespread acceptance of the intervention.”
    Quote in the paperNot a substantial claim
61 of 61

  • The paper relies on this without support.

    Vital sign measurement is an international standard part of maternity care.

    “Vital sign measurement is an international standard part of maternity care.”
    “given it is a validated, accurate device and vital signs measurement is part of standard care during pregnancy and the post-partum period.”

  • The paper relies on this without support.

    The CRADLE VSA device is cost-effective (less than $20) and can be used effectively by unskilled personnel after minimal training.

    “It is cost-effective (less than $20) and can be used effectively by unskilled personnel after minimal training.”

  • The paper relies on this without support.

    Clinical effectiveness of the CRADLE intervention to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability at scale, has yet to be investigated.

    “Clinical effectiveness to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability of the CRADLE intervention at scale has yet to be investigated.”

  • The paper relies on this without support.

    Primary outcome data from routinely collected sources are accurate and complete enough to assess the trial outcomes.

    “Analysis of each outcome will be as a proportion of all deliveries during the six-week period within that district, as assessed from routinely collected data.”
    “The primary outcome measures will be assessed by the numbers of events reported at the district (or referral) hospital and the peripheral health units offering the highest level of care (defined as the 20% with the highest level facilities in each district).”

  • The paper relies on this without support.

    The CRADLE intervention is of minimal risk and does not adversely affect the rights and welfare of individual women.

    “However, the CRADLE intervention (i.e. blood pressure and pulse measurement, and training) is an international standard, is of minimal risk and does not adversely affect the rights and welfare of the individual women.”

  • The paper relies on this without support.

    The thresholds that trigger the CRADLE traffic lights were determined through pregnancy-specific prediction studies.

    “The thresholds that trigger the traffic lights were determined through pregnancy-specific prediction studies.”

  • The authors state this as an assumption.

    For the purposes of the power calculation, the study assumes up to 1000 deliveries per district per six weeks (half the 2000 considered likely), across eight districts, each observed for 12 months.

    “For the purposes of the power calculation, we assume that there are up to 1000 deliveries per district per six weeks (half the 2000 we consider likely), across eight districts, each observed for 12 months.”

  • The paper relies on this without support.

    The majority of maternal deaths in Sierra Leone are preventable if deteriorating vital signs are detected early, enabling simple interventions to be delivered, which are available in Sierra Leone.

    “The majority of deaths are preventable if deteriorating vital signs are detected early, enabling simple interventions to be delivered, which are available in SL.”

  • The paper relies on this without support.

    Access to vital signs monitoring equipment and skilled intervention is often limited, especially in rural settings, leading to delays in escalation and delivery of care.

    “However, access to vital signs monitoring equipment and skilled intervention is often limited, especially in rural settings, leading to delays in escalation and delivery of care.”

  • The paper relies on this without support.

    Clinical effectiveness of introduction of the CRADLE intervention to improve maternal and perinatal health in rural areas, and integration and sustainability have yet to be investigated.

    “Clinical effectiveness of introduction of the CRADLE intervention to improve maternal and perinatal health in rural areas, and integration and sustainability have yet to be investigated.”
10 of 10

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Health facilities were strategically chosen as clusters in numerous stepped-wedge studies in sub-Saharan Africa.

    “Health facilities, strategically chosen as clusters in numerous studies, underscore the emphasis on healthcare delivery and interventions within controlled environments.”

    From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [27]

    The Study setting section identifies eight Sierra Leone districts as the trial clusters, and Sequence generation {16a} explicitly says the unit of randomisation is a district. Healthcare facilities are included within those districts, not chosen as clusters. This single protocol also does not establish what occurred in numerous studies. (LLM, conf=0.87)

    Checked by a reasoning model — may be wrong.

    Experimental — accuracy not yet measured

  • The everyday use of hospitals and clinics as clusters is rooted in their pivotal role in healthcare delivery, enabling the implementation and evaluation of interventions to enhance patient outcomes.

    “The everyday use of hospitals and clinics as clusters is rooted in their pivotal role in healthcare delivery, enabling the implementation and evaluation of interventions to enhance patient outcomes (26, 27, 30–34, 36–47, 49, 50, 52–71, 73–75, 77–81, 83–89, 91–96, 98–102, 104, 105, 107, 109).”

    From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [27]

    The Study setting and Outcomes sections describe delivering the intervention through hospitals and community health centres and evaluating maternal and fetal outcomes. But the Sequence generation section explicitly defines each trial cluster as a district, not a hospital or clinic. This paper therefore supports the role of healthcare facilities in implementation and evaluation, but not their identification as clusters in this trial. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

  • Administrative units such as districts and wards allowed for evaluating public health interventions across larger populations.

    “Administrative units such as districts and wards allowed for evaluating public health interventions across larger populations (26–28, 30, 33, 34, 36, 38, 42, 47, 51, 52, 62, 69, 71–73, 75–79, 84–86, 91, 92, 94–97, 99, 101, 104, 108, 109).”

    From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [27]

  • Several stepped-wedge studies focused on implementing health technologies and digital solutions to improve healthcare delivery and patient outcomes.

    “Several studies focused on implementing health technologies and digital solutions to improve healthcare delivery and patient outcomes (26, 27, 32, 54, 62, 79, 85, 90, 91, 94, 98, 101, 104, 105).”

    From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [27]

  • Some stepped-wedge interventions aimed to strengthen healthcare infrastructure and systems to improve service delivery and patient outcomes.

    “Some interventions aimed to strengthen healthcare infrastructure and systems to improve service delivery and patient outcomes (27, 49, 52, 54, 56–58, 60, 62, 65, 66, 68, 70, 72, 74, 77, 79, 84–88, 90, 91, 93–96).”

    From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [27]

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Two incompatible primary-outcome analysis models are specified

    Major

    The statistical methods first specify a binomial log-link model with separate linear trends to estimate risk ratios as the primary analysis. They then say the primary outcome will be analysed using multilevel logistic regression with random centre effects and categorical time effects, which specifies a different model and effect measure.

  • Conflicting rules assign events to trial periods

    Major

    The data-collection plan assigns an event to the period of the woman's first presentation, even when the event occurs in a later period. The stated intention-to-treat rule instead assigns subjects according to the treatment at the centre when the event occurred; these rules can give different assignments for the paper's own example.

  • Outcome collection extends beyond the stated trial end

    Major

    The definitive trial is stated to run to June 2023, but the trial-status section says outcomes through 1 January 2024 will be included in the analysis. The stated end of the analysis period is therefore about six months later than the stated trial end.

  • Falaba is both described as having and lacking a secondary hospital

    Minor

    The general description says each district has a secondary hospital health centre, whereas the same section explicitly says Falaba does not have a secondary hospital.

4 of 4

Cites

Flagged first, then by citations

Cited by

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Related

Authors
Ridout, A. E., Moses, F. L., Herm-Singh, S., Turienzo, C. F., Seed, P. T., Goodhart, V., Vousden, N., Sam, B., Momoh, M., Kamara, D., Kuhrt, K., Samura, S., Beoku-Betts, C., Hurrell, A., Bramham, K., Kenneh, S., Smart, F., Chappell, L., Sandall, J., Shennan, A., & on behalf of CRIBS Collaborative Group
Affiliations
  • King's College London (GB)
  • Ministry of Health and Sanitation (SL)
  • University of Oxford (GB)
Corresponding author
Ridout, Alexandra E.
ORCID
Venue
Trials
Publisher
Springer Science and Business Media LLC
Published
2023-09-15
Volume
24
Issue
1
Pages
590-590
ISSN
1745-6215 (ISSN-L)
DOI
10.1186/s13063-023-07587-4
PMC
PMC10506317
OpenAlex
W4386834852
Semantic Scholar
dc6f5030dfb9a0993c167e49955d603adbdc8d9a
Cited by
8
References
27
Citations by year
2026: 3 · 2025: 4 · 2024: 1
FWCI
2.83
Type
journal article
Language
en
Open access
Licence
Locations
  • Trials (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Research Portal (King's College London) (submittedVersion, cc-by)
Funders
NIHR (NIHR133232)
Topics
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Global Maternal and Child Health
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Maternal and fetal healthcare
Keywords
blood pressure monitoring, pulse measurement, early warning systems, eclampsia prevention, maternal mortality, stillbirth, emergency hysterectomy, maternal morbidity, perinatal outcomes, scale-up, implementation effectiveness, rural maternity care, resource-limited settings, Sierra Leone, health professions education, cost-effectiveness, barriers and facilitators, complex interventions
MeSH terms
Blood Pressure, Eclampsia, Female, Humans, Infant, Maternal Health Services, Pregnancy, Sierra Leone, Randomized Controlled Trials as Topic, Maternal Death

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-07.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-07.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

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