Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial
Summary: 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 requir...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2019-03-01
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| Series: | The Lancet Global Health |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2214109X18305266 |
| _version_ | 1811193893892390912 |
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| author | Nicola Vousden, MBBS Elodie Lawley, BSc Hannah L Nathan, PhD Paul T Seed, CSTAT Muchabayiwa Francis Gidiri, FRCOG Shivaprasad Goudar, ProfMD Jane Sandall, PhD Lucy C Chappell, ProfFRCOG Andrew H Shennan, ProfFRCOG Monice Kachinjika Doreen Bukani Jane Makwakwa Grace Makonyola Adrian Brown Paul Toussaint Adeline Vixama Grace Greene Carwyn Hill Emily Nakiriija Doreen Birungi Noela Kalyowa Dorothy Namakula Josaphat Byamugisha Annettee Nakimuli Nathan Mackayi Odeke James Ditai Julius Wandabwa Fatmata Momodou Margaret Sesay Patricia Sandi Jeneba Conteh Jesse Kamara Matthew Clarke Rebecca Best Josephine Miti Mercy Kopeka Bellington Vwalika Martina Chima Thokozile Musonda Christine Jere Sebastian Chinkoyo Violet Mambo Yonas Guchale Lomi Yadeta Feiruz Surur Geetanjali M Mungarwadi Sphoorthi S Mastiholi Chandrappa C Karadiguddi Umesh Charantimath Mrutyunjaya Bellad Natasha Hezelgrave Kate E Duhig |
| author_facet | Nicola Vousden, MBBS Elodie Lawley, BSc Hannah L Nathan, PhD Paul T Seed, CSTAT Muchabayiwa Francis Gidiri, FRCOG Shivaprasad Goudar, ProfMD Jane Sandall, PhD Lucy C Chappell, ProfFRCOG Andrew H Shennan, ProfFRCOG Monice Kachinjika Doreen Bukani Jane Makwakwa Grace Makonyola Adrian Brown Paul Toussaint Adeline Vixama Grace Greene Carwyn Hill Emily Nakiriija Doreen Birungi Noela Kalyowa Dorothy Namakula Josaphat Byamugisha Annettee Nakimuli Nathan Mackayi Odeke James Ditai Julius Wandabwa Fatmata Momodou Margaret Sesay Patricia Sandi Jeneba Conteh Jesse Kamara Matthew Clarke Rebecca Best Josephine Miti Mercy Kopeka Bellington Vwalika Martina Chima Thokozile Musonda Christine Jere Sebastian Chinkoyo Violet Mambo Yonas Guchale Lomi Yadeta Feiruz Surur Geetanjali M Mungarwadi Sphoorthi S Mastiholi Chandrappa C Karadiguddi Umesh Charantimath Mrutyunjaya Bellad Natasha Hezelgrave Kate E Duhig |
| author_sort | Nicola Vousden, MBBS |
| collection | DOAJ |
| description | Summary: 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. |
| first_indexed | 2024-04-12T00:17:02Z |
| format | Article |
| id | doaj.art-739f8e38a0d34deba2536159f03c3e50 |
| institution | Directory Open Access Journal |
| issn | 2214-109X |
| language | English |
| last_indexed | 2024-04-12T00:17:02Z |
| publishDate | 2019-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | The Lancet Global Health |
| spelling | doaj.art-739f8e38a0d34deba2536159f03c3e502022-12-22T03:55:49ZengElsevierThe Lancet Global Health2214-109X2019-03-0173e347e356Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trialNicola Vousden, MBBS0Elodie Lawley, BSc1Hannah L Nathan, PhD2Paul T Seed, CSTAT3Muchabayiwa Francis Gidiri, FRCOG4Shivaprasad Goudar, ProfMD5Jane Sandall, PhD6Lucy C Chappell, ProfFRCOG7Andrew H Shennan, ProfFRCOG8Monice KachinjikaDoreen BukaniJane MakwakwaGrace MakonyolaAdrian BrownPaul ToussaintAdeline VixamaGrace GreeneCarwyn HillEmily NakiriijaDoreen BirungiNoela KalyowaDorothy NamakulaJosaphat ByamugishaAnnettee NakimuliNathan Mackayi OdekeJames DitaiJulius WandabwaFatmata MomodouMargaret SesayPatricia SandiJeneba ContehJesse KamaraMatthew ClarkeRebecca BestJosephine MitiMercy KopekaBellington VwalikaMartina ChimaThokozile MusondaChristine JereSebastian ChinkoyoViolet MamboYonas GuchaleLomi YadetaFeiruz SururGeetanjali M MungarwadiSphoorthi S MastiholiChandrappa C KaradiguddiUmesh CharantimathMrutyunjaya BelladNatasha HezelgraveKate E DuhigDepartment of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK; Correspondence to: Dr Nicola Vousden, Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London SE1 7EH, UKDepartment of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UKDepartment of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UKDepartment of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UKDepartment of Obstetrics and Gynaecology, College of Health Sciences, University of Zimbabwe, Harare, ZimbabweWomen's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belgaum, Karnataka, IndiaDepartment of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UKDepartment of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UKDepartment of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UKSummary: 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.http://www.sciencedirect.com/science/article/pii/S2214109X18305266 |
| spellingShingle | Nicola Vousden, MBBS Elodie Lawley, BSc Hannah L Nathan, PhD Paul T Seed, CSTAT Muchabayiwa Francis Gidiri, FRCOG Shivaprasad Goudar, ProfMD Jane Sandall, PhD Lucy C Chappell, ProfFRCOG Andrew H Shennan, ProfFRCOG Monice Kachinjika Doreen Bukani Jane Makwakwa Grace Makonyola Adrian Brown Paul Toussaint Adeline Vixama Grace Greene Carwyn Hill Emily Nakiriija Doreen Birungi Noela Kalyowa Dorothy Namakula Josaphat Byamugisha Annettee Nakimuli Nathan Mackayi Odeke James Ditai Julius Wandabwa Fatmata Momodou Margaret Sesay Patricia Sandi Jeneba Conteh Jesse Kamara Matthew Clarke Rebecca Best Josephine Miti Mercy Kopeka Bellington Vwalika Martina Chima Thokozile Musonda Christine Jere Sebastian Chinkoyo Violet Mambo Yonas Guchale Lomi Yadeta Feiruz Surur Geetanjali M Mungarwadi Sphoorthi S Mastiholi Chandrappa C Karadiguddi Umesh Charantimath Mrutyunjaya Bellad Natasha Hezelgrave Kate E Duhig 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 |
| 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 |
| title_full | Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial |
| title_fullStr | Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial |
| title_full_unstemmed | Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial |
| title_short | Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial |
| title_sort | effect of a novel vital sign device on maternal mortality and morbidity in low resource settings a pragmatic stepped wedge cluster randomised controlled trial |
| url | http://www.sciencedirect.com/science/article/pii/S2214109X18305266 |
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