King's College London

Research portal

Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial

Research output: Contribution to journalArticle

Standard

Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings : a pragmatic, stepped-wedge, cluster-randomised controlled trial. / CRADLE Trial Collaborative Group ; Vousden, Nicola; Lawley, Elodie; Nathan, Hannah L.; Seed, Paul T.; Gidiri, Muchabayiwa Francis; Goudar, Shivaprasad; Sandall, Jane; Chappell, Lucy C.; Shennan, Andrew H.; Kachinjika, Monice; Bukani, Doreen; Makwakwa, Jane; Makonyola, Grace; Brown, Adrian; Toussaint, Paul; Vixama, Adeline; Greene, Grace; Hill, Carwyn; Nakiriija, Emily; Birungi, Doreen; Kalyowa, Noela; Namakula, Dorothy; Byamugisha, Josaphat; Nakimuli, Annettee; Mackayi Odeke, Nathan; Ditai, James; Wandabwa, Julius; Momodou, Fatmata; Sesay, Margaret; Sandi, Patricia; Conteh, Jeneba; Kamara, Jesse; Clarke, Matthew; Best, Rebecca; Miti, Josephine; Kopeka, Mercy; Vwalika, Bellington; Chima, Martina; Musonda, Thokozile; Jere, Christine; Chinkoyo, Sebastian; Mambo, Violet; Guchale, Yonas; Yadeta, Lomi; Surur, Feiruz; Mungarwadi, Geetanjali M.; Mastiholi, Sphoorthi S.; Karadiguddi, Chandrappa C.; Hezelgrave, Natasha; Duhig, Kate E.

In: The Lancet. Global health, Vol. 7, No. 3, 03.2019, p. e347-e356.

Research output: Contribution to journalArticle

Harvard

CRADLE Trial Collaborative Group, Vousden, N, Lawley, E, Nathan, HL, Seed, PT, Gidiri, MF, Goudar, S, Sandall, J, Chappell, LC, Shennan, AH, Kachinjika, M, Bukani, D, Makwakwa, J, Makonyola, G, Brown, A, Toussaint, P, Vixama, A, Greene, G, Hill, C, Nakiriija, E, Birungi, D, Kalyowa, N, Namakula, D, Byamugisha, J, Nakimuli, A, Mackayi Odeke, N, Ditai, J, Wandabwa, J, Momodou, F, Sesay, M, Sandi, P, Conteh, J, Kamara, J, Clarke, M, Best, R, Miti, J, Kopeka, M, Vwalika, B, Chima, M, Musonda, T, Jere, C, Chinkoyo, S, Mambo, V, Guchale, Y, Yadeta, L, Surur, F, Mungarwadi, GM, Mastiholi, SS, Karadiguddi, CC, Hezelgrave, N & Duhig, KE 2019, 'Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial', The Lancet. Global health, vol. 7, no. 3, pp. e347-e356. https://doi.org/10.1016/S2214-109X(18)30526-6

APA

CRADLE Trial Collaborative Group, Vousden, N., Lawley, E., Nathan, H. L., Seed, P. T., Gidiri, M. F., ... Duhig, K. E. (2019). Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial. The Lancet. Global health, 7(3), e347-e356. https://doi.org/10.1016/S2214-109X(18)30526-6

Vancouver

CRADLE Trial Collaborative Group, Vousden N, Lawley E, Nathan HL, Seed PT, Gidiri MF 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. The Lancet. Global health. 2019 Mar;7(3):e347-e356. https://doi.org/10.1016/S2214-109X(18)30526-6

Author

CRADLE Trial Collaborative Group ; Vousden, Nicola ; Lawley, Elodie ; Nathan, Hannah L. ; Seed, Paul T. ; Gidiri, Muchabayiwa Francis ; Goudar, Shivaprasad ; Sandall, Jane ; Chappell, Lucy C. ; Shennan, Andrew H. ; Kachinjika, Monice ; Bukani, Doreen ; Makwakwa, Jane ; Makonyola, Grace ; Brown, Adrian ; Toussaint, Paul ; Vixama, Adeline ; Greene, Grace ; Hill, Carwyn ; Nakiriija, Emily ; Birungi, Doreen ; Kalyowa, Noela ; Namakula, Dorothy ; Byamugisha, Josaphat ; Nakimuli, Annettee ; Mackayi Odeke, Nathan ; Ditai, James ; Wandabwa, Julius ; Momodou, Fatmata ; Sesay, Margaret ; Sandi, Patricia ; Conteh, Jeneba ; Kamara, Jesse ; Clarke, Matthew ; Best, Rebecca ; Miti, Josephine ; Kopeka, Mercy ; Vwalika, Bellington ; Chima, Martina ; Musonda, Thokozile ; Jere, Christine ; Chinkoyo, Sebastian ; Mambo, Violet ; Guchale, Yonas ; Yadeta, Lomi ; Surur, Feiruz ; Mungarwadi, Geetanjali M. ; Mastiholi, Sphoorthi S. ; Karadiguddi, Chandrappa C. ; Hezelgrave, Natasha ; Duhig, Kate E. / Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings : a pragmatic, stepped-wedge, cluster-randomised controlled trial. In: The Lancet. Global health. 2019 ; Vol. 7, No. 3. pp. e347-e356.

Bibtex Download

@article{544396d695ec437d8e1bc0f1b9f83ba9,
title = "Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial",
abstract = "Background In 2015, an estimated 303 000 women died in pregnancy and childbirth. Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account for more than 50{\%} of maternal deaths worldwide. There are effective treatments for these pregnancy complications, but they require early detection by measurement of vital signs and timely administration to save lives. The primary aim of this trial was to determine whether implementation of the CRADLE Vital Sign Alert and an education package into community and facility maternity care in low-resource settings could reduce a composite of all-cause maternal mortality or major morbidity (eclampsia and hysterectomy). Methods We did a pragmatic, stepped-wedge, cluster-randomised controlled trial in ten clusters across Africa, India, and Haiti, introducing the device into routine maternity care. Each cluster contained at least one secondary or tertiary hospital and their main referral facilities. Clusters crossed over from existing routine care to the CRADLE intervention in one of nine steps at 2-monthly intervals, with CRADLE devices replacing existing equipment at the randomly allocated timepoint. A computer-generated randomly allocated sequence determined the order in which the clusters received the intervention. Because of the nature of the intervention, this trial was not masked. Data were gathered monthly, with 20 time periods of 1 month. The primary composite outcome was at least one of eclampsia, emergency hysterectomy, and maternal death. This study is registered with the ISRCTN registry, number ISRCTN41244132. Findings Between April 1, 2016, and Nov 30, 2017, among 536 223 deliveries, the primary outcome occurred in 4067 women, with 998 maternal deaths, 2692 eclampsia cases, and 681 hysterectomies. There was an 8{\%} decrease in the primary outcome from 79·4 per 10 000 deliveries pre-intervention to 72·8 per 10 000 deliveries post-intervention (odds ratio [OR] 0·92, 95{\%} CI 0·86–0·97; p=0·0056). After planned adjustments for variation in event rates between and within clusters over time, the unexpected degree of variability meant we were unable to judge the benefit or harms of the intervention (OR 1·22, 95{\%} CI 0·73–2·06; p=0·45). Interpretation There was an absolute 8{\%} reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability. We encountered unanticipated methodological challenges with this trial design, which can provide valuable learning for future research and inform the trial design of future international stepped-wedge trials. Funding Newton Fund Global Research Programme: UK Medical Research Council; Department of Biotechnology, Ministry of Science & Technology, Government of India; and UK Department of International Development.",
author = "{CRADLE Trial Collaborative Group} and Nicola Vousden and Elodie Lawley and Nathan, {Hannah L.} and Seed, {Paul T.} and Gidiri, {Muchabayiwa Francis} and Shivaprasad Goudar and Jane Sandall and Chappell, {Lucy C.} and Shennan, {Andrew H.} and Monice Kachinjika and Doreen Bukani and Jane Makwakwa and Grace Makonyola and Adrian Brown and Paul Toussaint and Adeline Vixama and Grace Greene and Carwyn Hill and Emily Nakiriija and Doreen Birungi and Noela Kalyowa and Dorothy Namakula and Josaphat Byamugisha and Annettee Nakimuli and {Mackayi Odeke}, Nathan and James Ditai and Julius Wandabwa and Fatmata Momodou and Margaret Sesay and Patricia Sandi and Jeneba Conteh and Jesse Kamara and Matthew Clarke and Rebecca Best and Josephine Miti and Mercy Kopeka and Bellington Vwalika and Martina Chima and Thokozile Musonda and Christine Jere and Sebastian Chinkoyo and Violet Mambo and Yonas Guchale and Lomi Yadeta and Feiruz Surur and Mungarwadi, {Geetanjali M.} and Mastiholi, {Sphoorthi S.} and Karadiguddi, {Chandrappa C.} and Natasha Hezelgrave and Duhig, {Kate E.}",
year = "2019",
month = "3",
doi = "10.1016/S2214-109X(18)30526-6",
language = "English",
volume = "7",
pages = "e347--e356",
journal = "The Lancet. Global health",
issn = "2214-109X",
publisher = "Elsevier BV",
number = "3",

}

RIS (suitable for import to EndNote) Download

TY - JOUR

T1 - Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings

T2 - a pragmatic, stepped-wedge, cluster-randomised controlled trial

AU - CRADLE Trial Collaborative Group

AU - Vousden, Nicola

AU - Lawley, Elodie

AU - Nathan, Hannah L.

AU - Seed, Paul T.

AU - Gidiri, Muchabayiwa Francis

AU - Goudar, Shivaprasad

AU - Sandall, Jane

AU - Chappell, Lucy C.

AU - Shennan, Andrew H.

AU - Kachinjika, Monice

AU - Bukani, Doreen

AU - Makwakwa, Jane

AU - Makonyola, Grace

AU - Brown, Adrian

AU - Toussaint, Paul

AU - Vixama, Adeline

AU - Greene, Grace

AU - Hill, Carwyn

AU - Nakiriija, Emily

AU - Birungi, Doreen

AU - Kalyowa, Noela

AU - Namakula, Dorothy

AU - Byamugisha, Josaphat

AU - Nakimuli, Annettee

AU - Mackayi Odeke, Nathan

AU - Ditai, James

AU - Wandabwa, Julius

AU - Momodou, Fatmata

AU - Sesay, Margaret

AU - Sandi, Patricia

AU - Conteh, Jeneba

AU - Kamara, Jesse

AU - Clarke, Matthew

AU - Best, Rebecca

AU - Miti, Josephine

AU - Kopeka, Mercy

AU - Vwalika, Bellington

AU - Chima, Martina

AU - Musonda, Thokozile

AU - Jere, Christine

AU - Chinkoyo, Sebastian

AU - Mambo, Violet

AU - Guchale, Yonas

AU - Yadeta, Lomi

AU - Surur, Feiruz

AU - Mungarwadi, Geetanjali M.

AU - Mastiholi, Sphoorthi S.

AU - Karadiguddi, Chandrappa C.

AU - Hezelgrave, Natasha

AU - Duhig, Kate E.

PY - 2019/3

Y1 - 2019/3

N2 - Background In 2015, an estimated 303 000 women died in pregnancy and childbirth. Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account for more than 50% of maternal deaths worldwide. There are effective treatments for these pregnancy complications, but they require early detection by measurement of vital signs and timely administration to save lives. The primary aim of this trial was to determine whether implementation of the CRADLE Vital Sign Alert and an education package into community and facility maternity care in low-resource settings could reduce a composite of all-cause maternal mortality or major morbidity (eclampsia and hysterectomy). Methods We did a pragmatic, stepped-wedge, cluster-randomised controlled trial in ten clusters across Africa, India, and Haiti, introducing the device into routine maternity care. Each cluster contained at least one secondary or tertiary hospital and their main referral facilities. Clusters crossed over from existing routine care to the CRADLE intervention in one of nine steps at 2-monthly intervals, with CRADLE devices replacing existing equipment at the randomly allocated timepoint. A computer-generated randomly allocated sequence determined the order in which the clusters received the intervention. Because of the nature of the intervention, this trial was not masked. Data were gathered monthly, with 20 time periods of 1 month. The primary composite outcome was at least one of eclampsia, emergency hysterectomy, and maternal death. This study is registered with the ISRCTN registry, number ISRCTN41244132. Findings Between April 1, 2016, and Nov 30, 2017, among 536 223 deliveries, the primary outcome occurred in 4067 women, with 998 maternal deaths, 2692 eclampsia cases, and 681 hysterectomies. There was an 8% decrease in the primary outcome from 79·4 per 10 000 deliveries pre-intervention to 72·8 per 10 000 deliveries post-intervention (odds ratio [OR] 0·92, 95% CI 0·86–0·97; p=0·0056). After planned adjustments for variation in event rates between and within clusters over time, the unexpected degree of variability meant we were unable to judge the benefit or harms of the intervention (OR 1·22, 95% CI 0·73–2·06; p=0·45). Interpretation There was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability. We encountered unanticipated methodological challenges with this trial design, which can provide valuable learning for future research and inform the trial design of future international stepped-wedge trials. Funding Newton Fund Global Research Programme: UK Medical Research Council; Department of Biotechnology, Ministry of Science & Technology, Government of India; and UK Department of International Development.

AB - Background In 2015, an estimated 303 000 women died in pregnancy and childbirth. Obstetric haemorrhage, sepsis, and hypertensive disorders of pregnancy account for more than 50% of maternal deaths worldwide. There are effective treatments for these pregnancy complications, but they require early detection by measurement of vital signs and timely administration to save lives. The primary aim of this trial was to determine whether implementation of the CRADLE Vital Sign Alert and an education package into community and facility maternity care in low-resource settings could reduce a composite of all-cause maternal mortality or major morbidity (eclampsia and hysterectomy). Methods We did a pragmatic, stepped-wedge, cluster-randomised controlled trial in ten clusters across Africa, India, and Haiti, introducing the device into routine maternity care. Each cluster contained at least one secondary or tertiary hospital and their main referral facilities. Clusters crossed over from existing routine care to the CRADLE intervention in one of nine steps at 2-monthly intervals, with CRADLE devices replacing existing equipment at the randomly allocated timepoint. A computer-generated randomly allocated sequence determined the order in which the clusters received the intervention. Because of the nature of the intervention, this trial was not masked. Data were gathered monthly, with 20 time periods of 1 month. The primary composite outcome was at least one of eclampsia, emergency hysterectomy, and maternal death. This study is registered with the ISRCTN registry, number ISRCTN41244132. Findings Between April 1, 2016, and Nov 30, 2017, among 536 223 deliveries, the primary outcome occurred in 4067 women, with 998 maternal deaths, 2692 eclampsia cases, and 681 hysterectomies. There was an 8% decrease in the primary outcome from 79·4 per 10 000 deliveries pre-intervention to 72·8 per 10 000 deliveries post-intervention (odds ratio [OR] 0·92, 95% CI 0·86–0·97; p=0·0056). After planned adjustments for variation in event rates between and within clusters over time, the unexpected degree of variability meant we were unable to judge the benefit or harms of the intervention (OR 1·22, 95% CI 0·73–2·06; p=0·45). Interpretation There was an absolute 8% reduction in primary outcome during the trial, with no change in resources or staffing, but this reduction could not be directly attributed to the intervention due to variability. We encountered unanticipated methodological challenges with this trial design, which can provide valuable learning for future research and inform the trial design of future international stepped-wedge trials. Funding Newton Fund Global Research Programme: UK Medical Research Council; Department of Biotechnology, Ministry of Science & Technology, Government of India; and UK Department of International Development.

UR - http://www.scopus.com/inward/record.url?scp=85061361399&partnerID=8YFLogxK

U2 - 10.1016/S2214-109X(18)30526-6

DO - 10.1016/S2214-109X(18)30526-6

M3 - Article

C2 - 30784635

AN - SCOPUS:85061361399

VL - 7

SP - e347-e356

JO - The Lancet. Global health

JF - The Lancet. Global health

SN - 2214-109X

IS - 3

ER -

View graph of relations

© 2018 King's College London | Strand | London WC2R 2LS | England | United Kingdom | Tel +44 (0)20 7836 5454