Ethical Issues in Medical and Scientific Publication

Chris Taylor/Save the Children The Lancets Stillbirth Series Presenter name Title Location of presentation Date On behalf of The LancetsStillbirth Series Steering Committee The Lancets Stillbirth Series 6 papers 1. Invisibility of stillbirth: Making the unseen seen 2. Information on making stillbirths count: Where? When? Why? 3. Interventions: evidence on what works 4. Implementation: integrated care has triple benefit 5. High-income settings: priority actions 6. 2020 vision: goals and research priorities

All papers can be accessed free at www.thelancet.com/series/stillbirth The Lancets Stillbirth Series Research articles (2) Stillbirth rate estimate and trends for 193 countries Risk factors for stillbirth in high-income countries Commentaries (8) Lancet editors Parents perspective Professionals perspective and commitment Including stillbirths in family health Stillbirth estimates Stillbirth risk factors Inequalities in stillbirth Stillbirth and reproductive rights Executive summary also available in French and Italian

The team 69 authors from 18 countries Over 50 partner organizations Funding by all the partners, with The Bill & Melinda Gates Foundation as the main funder The Lancets Stillbirth Series Steering committee

Name Affiliation J Frederik Fren Norwegian Institute of Public Health and International Stillbirth Alliance, Norway Joy E. Lawn Saving Newborn Lives/Save the Children, South Africa Zulfiqar A. Bhutta Division of Women and Child Health, Aga Khan University, Pakistan Robert Pattinson

Medical Research Council and University of Pretoria, South Africa Vicki Flenady International Stillbirth Alliance and Mater Medical Research Institute, Australia Robert L Goldenberg Department of Obstetrics and Gynecology, Drexel University, USA Monir Islam Family Health and Research, WHO Regional Office for South-East Asia Special thanks to Zo Mullan, Senior Editor at The Lancet and Mary Kinney,

International Stillbirth Alliance consultant Definition of stillbirth In the Series, stillbirth refers to all pregnancy losses after 22 weeks of gestation. WHO definition of stillbirth is a birthweight of at least 1000 g or a gestational age of at least 28 weeks (third trimester stillbirth). New stillbirth estimates for 193 countries using WHO definition In some high-income countries other definitions are used If high-income country stillbirth definitions In UK stillbirths are counted

from 24 weeks were used for all countries then the global total would In USA, Australia and New Zealand frombe 20 about weeks 45% higher Defining stillbirths Paper 1: Stillbirth visibility What is new?

Two web-based surveys of health professionals from 135 countries and parents from 32 countries regarding perceptions of stillbirth Review of current global policy Socio-political analysis of who owns stillbirths Suggestions for how stillbirths could gain more visibility Source: Fren JF, Cacciatore J, McClure EM, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: why they matter. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62232-5. Perceptions of the stillborn baby and mother Stillborn babies do not get societal or family recognition - rarely named, have funeral rites or are held or dressed by the mother One in four stillborn babies is not seen by either the mother or her family Nearly one third of stillbirths are attributed to the

mothers sins or evil spirits Many people believe that stillbirth is a natural selection process and that the baby was not destined to live Two of every three stillbirths occur where there is no proper public understanding about stillbirths and where Source: Fren JF, Cacciatore J, McClure or EM, etinternational al, for The Lancets Stillbirths Series steering committee. Stillbirths: why they stillbirth matter. Lancet 2011; published no national institution guides online April 14. DOI:10.1016/S0140-6736(10)62232-5.

Perceptions of the stillborn baby and mother Source: Fren JF, Cacciatore J, McClure EM, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: why they matter. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62232-5. Stillbirth is a marker of development and womens status Stillbirth rates inversely correlate with: The wealth and development of nations Secondary education Reproductive control, such as the use of contraceptives Source: Fren JF, Cacciatore J, McClure EM, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: why they matter. Lancet 2011; published

online April 14. DOI:10.1016/S0140-6736(10)62232-5. Addressing the void of ownership for stillbirths In global efforts in maternal health, the womans own aspiration of a live baby is missing from the worlds health agenda Newborn survival gets more attention, especially by representing 41% of the MDG 4 target Stillbirth attention must link to these and also needs to be institutionalised in UN and professional bodies Parental groups must join with professional bodies eg midwives (ICM) obstetricians (FIGO) towhyadvocate for Source: Fren

JF, Cacciatore J, McClure EM, et al, and for The Lancets Stillbirths Series steering committee. Stillbirths: they matter. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62232-5. Paper 1: Why stillbirths matter Key messages Stillbirths have been relatively overlooked as a global public health problem Not included in the Millennium Development Goals for maternal and child health set by the UN Social perception affected women are often subjected to stigma and marginalisation in communities that blame her stillbirth on her own sins, evil spirits, and destiny

Parental groups must join with professional bodies eg midwives (ICM) and obstetricians (FIGO) to advocate for Source: Fren JF, etchange al. Stillbirths: why they matter. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62232-5. Paper 2: Counting stillbirths What is new? New estimates of stillbirth rate for 193 countries - Undertaken by Saving Newborn Lives/Save the Children and London School of Hygiene and Tropical medicine with the World Health Organization and a process to discuss the data with countries - Large increases in the input data, more reported data, better modelling - Time trends from 1995 to 2009 (first time ever) New estimates of intrapartum stillbirths

Advances towards more comparable cause comparisons Source: Lawn JE, et al. Stillbirths: Where? When? Why? How to make the data count? Lancet 2011; published online April 14. DOI:10.1016/S01406736(10)62187-3. Stillbirths dont count in global numbers 1. Global mortality tracking NOT measured in most national surveys and NOT routinely reported to WHO 2. MDGs Stillbirths NOT mentioned in the MDGs although intimately linked to: Maternal deaths and near misses in MDG 5 Neonatal deaths, accounting for 41% of child deaths in MDG4 Poverty (MDG 1) and girls education (MDG2)

3. Global burden Stillbirths not been included in the Global Burden of Disease or in DALYs Stillbirths often missed in national or international health policy Source: Lawn JE, et al. Stillbirths: and Where?programmes When? Why? How to make the data count? partly Lancet 2011; a data published online issue April 14. DOI:10.1016/S01406736(10)62187-3. Defining stillbirths

WHO international definition Source: Lawn JE, Blencowe H, Pattinson R, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: Where? When? Why? How to make the data count? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62187-3. DATA TYPE VITAL REGISTRATION (VR) HOUSEHOLD SURVEYS SYSTEMATIC REVIEW [ 79 countries, 974 data points] [ 50 countries, 99 surveys ]

[ June 2003-Sept 2010] 7486 titles/ abstracts reviewed 5551 excluded as no SBR reported Paper not found (3) 1932 papers reviewed Plus 110 data points from SNL/IMMPACT study1 restricted to 1995 or later EXCLUSIONS 1703 did not meet initial inclusion criteria for year after 1995, or SBR defn 339 papers included Country has national VR data (8)

Country has national VR data (128) Ratio of: SBR:NMR < 0.25 (6) or SBR:NMR < 4.0 (1) Ratio of: SBR:NMR < 0.25 (22) or SBR:NMR > 4.0 (0) Ratio of SBR:NMR < 0.25 (9) or > 4.0 (1) Duplicate studies (88) INCLUDED Good VR Other VR

[ 752 data points, 57 countries] [ 215 data points, 22 countries] ESTIMATION DATASET ESTIMATE USED Household surveys nationally representative Health facility minimal bias*

Health facility with bias** Other [ 39 countries, 69 surveys ] [ 16 studies, 9 countries] [ 50 studies, 25 countries] [47 studies, 22 countries] ESTIMATION DATASET [ 129 countries, 1149 data points]

Good VR and recent (2007-2009) [33 countries] Good VR adjusted for stillbirth definition [24 countries] Good VR no recent data Modelled stillbirth rate [7 countries] Modelled stillbirth rate [129 countries]

Source: Lawn JE, et al. Stillbirths: Where? When? Why? How to make the data count? Lancet 2011. Country variation in stillbirth rates 2.65 million third trimester stillbirths each year Applying highincome country stillbirth definitions (second and third trimester) this number may be 40% higher 10 countries account for 66% of

the worlds stillbirths and also 66% of neonatal deaths and over 60% of maternal deaths 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. India Pakistan

Nigeria China Bangladesh Dem Rep Congo Ethiopia Indonesia Tanzania Afghanistan 98% of stillbirths occur in low-income and middle-income countries; more than two-thirds are in rural families Source: Lawn JE, Blencowe H, Pattinson R, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: Where? When? Why? How to make the data count? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62187-3. Regional variation of intrapartum stillbirth rates

Worldwide, 1.2 million stillbirths occur during labour (intrapartum) The risk of intrapartum stillbirth for an African woman is 24 times higher Source: Lawn JE, Blencowe H, Pattinson R, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: Where? When? Why? How to make the data count? Lancet 2011; published online April 14. a DOI:10.1016/S0140-6736(10)62187-3. than for woman in a high-income country Cause of stillbirth Estimates for stillbirth are impeded by more than 35 different classification systems The big five causes: 1. Childbirth complications 2. Maternal infections in pregnancy 3. Maternal conditions, especially hypertension and diabetes

4. Fetal growth restriction 5. Congenital abnormalities These overlap with the causes of maternal and neonatal Source: Lawn JE, Blencowe H, Pattinson R, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: Where? When? Why? How to make the deaths data count? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62187-3. 2 million deaths at the time of birth: Triple return on investment Maternal deaths Stillbirths (>1000 g) Neonatal deaths 358,000 per year

2.65 million per year 3.6 million per year Intrapartum-related maternal deaths (2008) Intrapartum stillbirths (2009) Fetal death during labour (fresh stillbirths) Death during labour, birth and first 24 hrs + 261,000 Intrapartum-related neonatal deaths (2009)

Previously called birth asphyxia + 1,200,000 Source: Lawn JE, et al. Stillbirths: Where? When? Why? How to make the data count? Lancet 2011 814,000 Regional stillbirth rates trends and projections to 2020 Sub-Saharan Africa and south Asia have the slowest rates of decline Source: Lawn JE, Blencowe H, Pattinson R, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: Where? When? Why? How to make the America, Eurasia, and east Asia have made more progress

data count?Latin Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62187-3. Paper 2: Counting stillbirths Key messages Where? 2.6 million per year, 98% in low-income countries 55% in rural families in south Asia and sub-Sahara Africa When? 1.2 million while the woman is in labour (intrapartum) 1.4 million before labour Why? The big five causes link with causes of maternal and neonatal deaths Improving the data?

Already news with WHO releasing official estimates Urgent need to improve stillbirth data in household surveys and simplify cause of death classification Source: Lawn JE, et al. Stillbirths: Where? When? Why? How to make the data count? Lancet 2011 Paper 3: Interventions What is new? Systematic reviews for interventions with effect on stillbirth Effect of 35 interventions reviewed and 10 interventions selected Delphi process to agree effect on stillbirths where studies not available eg for comprehensive obstetric care effect Lives Saved Tool (LiST) and cost modelling New module added to liST to address stillbirths How many stillbirths could be averted at universal coverage? Which interventions have the most effect and may be more feasible in low income settings? Running cost per year of the interventions

Research priorities for interventions Source: Bhutta Z, et al. Stillbirths: what difference can we make and at what cost? Lancet 2011; published online April 14. Systematic review of potential interventions (additional background papers) 1. Ishaque S, Yakoob MY, Imdad A, Goldenberg RL, Eisele TP, Bhutta ZA. Effectiveness of interventions to screen and manage infections during pregnancy on reducing stillbirths: a review. BMC Public Health 2011, 11(Suppl 3):S3. doi:10.1186/1471-2458-11-S3-S3 2. Imdad A, Yakoob MY, Siddiqui S, Bhutta ZA. Screening and triage of intrauterine growth restriction (IUGR) in general population and high risk pregnancies: a systematic review with a focus on reduction of IUGR related stillbirths. BMC Public Health 2011, 11(Suppl 3):S1. doi:10.1186/1471-2458-11-S3-S1

3. Imdad A, Yakoob MY, Bhutta ZA. The effect of folic acid, protein energy and multiple micronutrient supplements in pregnancy on stillbirths. BMC Public Health 2011, 11 (Suppl 3):S4. doi:10.1186/1471-245811-S3-S4 4. Yakoob MY, Ali MA, Ali MU, Imdad A, Lawn JE, Den Broek NV, Bhutta ZA. The effect of providing skilled birth attendance and emergency obstetric care in preventing stillbirths. BMC Public Health 2011, 11(Suppl 3):S7. doi:10.1186/1471-2458-11-S3-S7 5. Syed M, Javed H, Yakoob MY, Bhutta ZA. Effect of screening and management of diabetes during pregnancy on stillbirths. BMC Public Health 2011, 11(Suppl 3):S2. doi:10.1186/1471-2458-11-S3-S2 6. Hussain AA, Yakoob MY, Imdad A, Bhutta ZA. Elective induction for pregnancies at or beyond 41 weeks of

gestation and its impact on stillbirths: a systematic review with meta-analysis. BMC Public Health 2011, 11(Suppl 3):S5. doi:10.1186/1471-2458-11-S3-S5 7. Jabeen M, Yakoob MY, Imdad A, Bhutta ZA. Impact of interventions to prevent and manage preeclampsia and eclampsia on stillbirths. BMC Public Health 2011, 11(Suppl 3):S6. doi:10.1186/1471-2458-11-S3-S6 Interventions selected for implementation and modeling 1. Periconceptional folic acid fortification 2. Prevention of malaria with insecticide-treated bednets or intermittent preventive treatment with antimalarials 3. Syphilis detection and treatment 4. Detection and management of hypertensive disease of pregnancy 5. Detection and management of diabetes of pregnancy 6. Detection and management of fetal growth restriction (including caesarean section or induction, if needed)

7. Identification and induction of mothers with 41 weeks of gestation 8. Skilled care at birth and immediate care for neonates 9. Basic emergency obstetric care 10.Comprehensive emergency obstetric care Source: Bhutta Z, et al. Stillbirths: what difference can we make and at what cost? Lancet 2011; published online April 14. 10 evidence-based interventions for stillbirth Interventions considered in the model 99% coverage Stillbirths Periconceptual folic acid supplementation Basic antenatal care Malaria in pregnancy - ITNs & IPTp Syphilis screening and treatment Hypertensive diseases in pregnancy and management

Advanced Diabetes screening and management antenatal care Fetal growth restriction management Induction of labor at or beyond 41 completed weeks Obstetric Care (3 levels of care) Reduction 27,000 1% 35,000 1% 136,000

5% 57000 2% 24,000 1% 107,000 4% 52,000 2% 696,000

28% Total stillbirths averted 1,134,000 45% Childbirth care Coverage is low and there are many missed opportunities within Source: Bhutta Z, et al. Stillbirths: what difference can we make and at what cost? Lancet 2011; published online April antenatal 14. existing

health system contact points, especially care Coverage of interventions for stillbirths in 68 Countdown countries Source: Bhutta ZA, Yakoob MY, Lawn JE, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: what difference can we make and at what cost? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62050-8. Universal coverage with 10 interventions 45% of stillbirths averted (1.13 million) Source: Bhutta Z, et al. Stillbirths:and what difference

can we make andservices at what cost? Lancetalone 2011; published online April 14. Community outreach could avert 280,000 Universal coverage will cost $9.6 billion for the 10 inventions that prevent stillbirths Costs largely determined by facility-based basic and Source: emergency Bhutta Z, et al. Stillbirths: what difference can we make and at what cost? Lancet published online April 14.

obstetric care and the2011;advanced packages of Paper 3 and 4: Interventions and Implementation What is new? Systematic reviews for interventions to reduce stillbirths Effect of 35 interventions were reviewed. 10 interventions clearly effective in reducing stillbirth New computerized model created to estimate How many stillbirths could be prevented with various

treatments? How many mothers and newborns would also be saved? What is the cost of introducing various interventions? Implementation priorities based on feasibility and cost 10 evidence-based interventions for stillbirth Source: Bhutta Z, et al. Stillbirths: what difference can we make and at what cost? Lancet 2011; published online April 14. Paper 3: Interventions Key messages Of 35 potential interventions, we strongly recommend ten for

implementation including: periconceptional folic acid fortification, insecticide-treated bednets or intermittent preventive treatment for malaria prevention, syphilis detection and treatment, detection and management of hypertensive disease of pregnancy, detection and management of diabetes of pregnancy, detection and management of fetal growth restriction, routine induction to prevent post-term pregnancies, skilled care at birth, basic emergency obstetric care, and comprehensive emergency obstetric care. Childbirth care, particularly emergency obstetric care including caesarean section, reduces the highest number of stillbirths, and should be the first priority, especially because of the additional benefits to women and neonates. Estimates modelled with the Lives Saved Tool indicate that 99% coverage

with these ten interventions could prevent 45% of stillbirths at a cost of Paper 3: Interventions Key research gaps Stillbirth data (intrapartum versus antepartum) should be included in all existing surveillance sites, and instruments developed to assess gestational age for stillbirths Improved detection and management of pregnancy-induced hypertension, detection of fetal distress and the use of modified partograph for optimal management of labour Appropriate detection and management of infections in the antenatal period such as urinary tract infections, preterm premature rupture of membranes and their association with the risk of stillbirths The role of birth spacing promotion and interventions to address environmental risk factors were also highlighted as priorities for research Paper 4: Implementation What is new?

Lives Saved Tool (LiST) and cost modelling for the effect on mothers, newborns AND stillbirths How many stillbirths could be averted at universal coverage? Which interventions have the most effect and may be more feasible in low-income settings? Running cost per year of the interventions Interfaces for health system change Research priorities for interventions Source: Pattinson R, Kerber K, Buchmann E, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: how can health systems deliver for mothers and babies? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62306-9. Continuum of care 10 effective interventions to reduce stillbirths overlap with those to reduce maternal and neonatal death. 5 addition maternal and neonatal interventions:

Tetanus toxoid Antibiotics for PPROM Antenatal steroids AMTSL Neonatal resuscitation 1 primary prevention Family planning! Interventions are most cost-effective provided through integrated packages that are tailored to suit existing health-care systems Source: Pattinson R, Kerber K, Buchmann E, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: how can health systems deliver for mothers and babies? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62306-9. Saving lives and preventing stillbirths Universal (99%) coverage could prevent 1.2 million stillbirths, 1.1 million newborn deaths (44%) and up to 201 000 maternal deaths (54%)

Source: Pattinson R, Kerber K, Buchmann E, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: how can health systems deliver for mothers and babies? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62306-9. Preventing maternal and neonatal deaths and stillbirths Childbirth care Basic antenatal Advanced antenatal Deaths prevented: Stillbirths 1.1 million (45%) Newborn deaths 1.4 (43%) Maternal deaths 201,000 (54%) TRIPLE RETURN ON INVESTMENT

Source: Pattinson R, Kerber K, Buchmann E, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: how can health systems deliver for mothers and babies? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62306-9. Triple benefit is cost effective US$ 10.9 billion or US$ 2.32 per person for the 68 priority countries is the additional cost of universal coverage for the 10 interventions that prevent stillbirths plus the 5 additional interventions for maternal and newborn health The cost per stillbirth averted decreases by half when integrated with maternal and newborn health (from US$9,600 to $3,920) Source: Pattinson R, Kerber K, Buchmann E, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: how can health systems deliver for mothers and babies? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62306-9. Key health-system interfaces

for change A health-care system is a complex adaptive system Interventions at the key interfaces are needed to successfully implement and sustain programmes Source: Pattinson R, Kerber K, Buchmann E, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: how can health systems deliver for mothers and babies? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62306-9. Paper 4: Implementation Key messages Effective interventions to reduce stillbirths often overlap with those to reduce maternal and neonatal deaths.

Interventions are best packaged are best integrated to provide a continuum of care from before pregnancy through to postnatal care Interventions should be tailored to the health-system context, with skilled care at birth and emergency obstetric care taking priority. In 68 countries accounting for 92% of the worldwide burden of stillbirths in 2008, universal coverage of care (99%) with intervention packages in 2015 could save up to 11 million (45%) third-trimester stillbirths, 201 000 (54%) maternal deaths, and 14 million (43%) neonatal deaths at an additional cost of US$232 per person, which is well below the WHO and World Bank criteria for cost-effectiveness. A health-care system is a complex adaptive system, so interventions at the key interfaces are needed to successfully implement and sustain programmes. Source: Pattinson R, Kerber K, Buchmann E, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: how can health systems deliver for mothers and babies? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62306-9.

Paper 5: High-income countries What is new? Stillbirth data and time trends from 13 countries Causes and contributing conditions using a single classification system across high-income countries Risk factors analysis Systematic review of studies addressing lifestyle risk factors including obesity, advanced maternal age and smoking Research priorities: survey of experts Source: Flenady V, Middleton P, Smith GC, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the way forward in high-income countries. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60064-0. Main causes of stillbirth in high-income countries Placental pathology 30% X Dysfunction with grow restriction and abruption Infection, largely associated with preterm birth 12%

Congenital abnormalities - 6% Maternal hypertension and diabetes - <5% (3-fold increased risk) 30% remain unexplained (10 times SIDS numbers) Source: Flenady V, Middleton P, Smith GC, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the way forward in high-income countries. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60064-0. Important risk factors in high-income countries Primiparity contributes to 14% of stillbirths Maternal age over 35 years 11% Smoking 6 % Giovanni Presutti CiaoLapo Maternal overweight 12%

Source: Flenady V, Koopmans L, Middleton, et al. Major risk factors for stillbirth in high-income countries: a systematic review and meta-analysis. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62233-7. Disadvantaged women in high-income countries Women living in disadvantage have stillbirth rates around double that of non-disadvantaged and equal to some low- and middle-income countries: eg, US African-American, Indigenous women in Canada and Australia and others living in socioeconomic deprivation Higher smoking rates (up to 60%) and access to appropriate health care and education are important factors Source: Flenady V, Middleton P, Smith GC, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the way forward in high-income countries. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60064-0.

Sub-optimal care contributes to around 30% of stillbirths. Audit against best practice standards can reduce stillbirth Most stillbirths are not thoroughly investigated and unexplained stillbirth may be overestimated by 50% Giovanni Presutti CiaoLapo Perinatal mortality audit Different approaches to classification of causes results in inadequate data

to inform prevention Source: Flenady V, Middleton P, Smith GC, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the way forward in high-income countries. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60064-0. Interventions to reduce stillbirth in high-income countries Antenatal detection and management of women with risk factors Detection of growth restriction, awareness of decreased fetal movements Sands UK Improvement of general health of women of childbearing age to achieve and maintain optimal weight and diet, smoking cessation Raising awareness of risk factors in the community

Improving information on causes through better investigation, audit and classification to focus research and clinical practice improvements Source: Flenady V, Middleton P, Smith GC, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the way forward in high-income countries. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60064-0. Research to reduce stillbirth in high-income countries Focus on antepartum stillbirth as a result of placental dysfunction and preterm birth and infection Effects of peri-conceptual environment of fetal development Understanding, detecting and managing fetal growth restriction Causes of stillbirth in minority groups Optimal investigations, classification and models of perinatal audit

Source: Flenady V, Middleton P, Smith GC, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the way forward in high-income countries. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60064-0. Stillbirths in highincome settings Differences between countries and within countries show that more reduction in stillbirth rates is achievable Source: Flenady V, Middleton P, Smith GC, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the way forward in high-income countries. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60064-0. Stillbirths in highincome settings Source: Flenady V, Middleton P, Smith GC, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the way forward in high-income countries. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60064-0. Paper 6: Vision 2020 History sets a precedent for rapid

stillbirth reduction Stillbirth rates halved in developed countries from 1950-1975 with improvements in obstetric care including hospitalization Source: Goldenberg RL, McClure EM, Bhutta ZA, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the vision for 2020. Lancet 2011; for delivery similar reductions are feasible in developing published online April 14. DOI:10.1016/S0140-6736(10)62235-0. Causes of stillbirth overlap with causes of maternal and neonatal deaths Source: Goldenberg RL, McClure EM, Bhutta ZA, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the vision for 2020. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62235-0. The Lancets Stillbirth Series Goal for 2020 All countries to reduce the stillbirth rate

to less than 5 per 1000 births, a rate already achieved in 40 high-income countries. For countries with a current stillbirth rate of less than 5 per 1000 births, the goal is to eliminate all preventable stillbirths and close equity gaps. For countries with a current stillbirth rate of more than 5 per 1000 births, the goal is to reduce their stillbirth rates by at least 50% from the 2008 rates if they cannot achieve a rate of less than 5 per 1000 births. The Lancets Stillbirth Series Call to action Achieving a substantial reduction in stillbirths worldwide by 2020 will require concerted efforts by many participants such as the international health agencies,

foundations, research institutions, individual countries and families. International Agencies The global partnerships currently advancing maternal and newborn health should include attention to and plans for stillbirth reduction. Funding for stillbirth prevention should be increased and integrated into donor programs funded to improve global maternal and newborn health. Individual Countries Every country should have a plan for implementing packages of maternal and neonatal care that includes a reduction in stillbirths. Each country should search for

disparities in stillbirth rates based on ethnicity, socioeconomic indicators, and location, and develop plans and programs to reduce those disparities. Communities and Families Every community will initiate efforts to increase awareness that stillbirth is a common occurrence, that they happen for medical reasons, and that many can be prevented. Every community will initiate efforts to acknowledge the impact of stillbirth on families, reduce stigma associated with stillbirth and meet the needs of The most important research questions The major research questions for reducing

stillbirths world-wide are: 1) How to build a system of care for pregnant women and newborns, and within such a system 2) How to increase coverage for the most important interventions: a) prenatal care and b) hospitalization at delivery Finally, and as soon as possible, we encourage all those with a specific interest in stillbirths to engage with those interested in improving other pregnancy outcomes so that a united front for improving all pregnancy outcomes is created.

We know what interventions work to improve pregnancy outcomes. Most are not highly technical and relatively easy to perform. We must make these interventions available and Reality for families Giovanni Presutti CiaoLapo Over 7200 families a day experience a stillbirth. But each one is an individual, painful story Whether they are famous or not, in a rich country or poor, the grief is overwhelming, and usually hidden

Personal story from local family Action priorities in highincome countries Reduce inequity, intentionally designing policies and programmes to reach underserved women from poorer communities or ethnic minorities Improve quality of care and use audit to link to change Address lifestyle risk factors such as obesity, smoking, and advanced maternal age. Identify ways to reduce maternal overweight and obesity Action priorities in lowand middle-income countries Source: Lawn JE, Kinney M. The Lancets Stillbirths Series Executive summary. Lancet 2011; published online April 14. Priority research themes Implementation in low-income and middle-income

countries: Adapt and scale up the most effective components of intrapartum care, particularly the appropriate use of caesarean section Adapt and scale up the most effective components of antenatal care, including how to screen for, prevent, and treat various maternal infections Implement effective quality-improvement programmes, including mortality audits, linking to change Assess the value of task shifting and the most cost-effective and sustainable training approaches Assess effective and sustainable mobilisation of communities at scale for behaviour change and care seeking Test models of care to improve support for women and families Source: Lawn JE, Kinney M. The Lancets Stillbirths Series Executive summary. Lancet 2011; published online April 14. Priority research themes Implementation in high-income countries: Reduce disparities in stillbirth rates between groups of different

ethnic origins and between people in rural and socioeconomically disadvantaged groups and people in affluent, urban groups Reduce risk factors associated with antepartum stillbirth Improve antenatal screening for risk factors for stillbirth, including fetal growth restriction Prevent early-gestational-age stillbirths Implement standard investigation protocols for every stillbirth and linked perinatal audit to improve the quality of maternity care Source: Lawn JE, Kinney M. The Lancets Stillbirths Series Executive summary. Lancet 2011; published online April 14. High priority research themes Data for programmatic action and tracking: Count stillbirths, including through household surveys, sentinel surveillance systems, and strengthening routine vital registration. Advance simplified classification of stillbirths that is useful for programme implementation, so that comparisons can be made

across locations and time periods, including the use of verbal and social autopsy methods in low-income and middle-income countries. Overcome barriers to weighing and gestational age assessment for stillborn babies by use of simplified surrogates such as foot size for gestational age. Improve detection of infections in pregnancy in settings with limited laboratory facilities. Source: Lawn JE, Kinney M. The Lancets Stillbirths Series Executive summary. Lancet 2011; published online April 14. Sands UK Goal by 2020 Countries with a current stillbirth rate of more than 5 per 1000 births to reduce their stillbirth rates by at least 50% from the 2008 rates Countries with a current stillbirth rate of less than 5 per 1000 births

to eliminate all preventable stillbirths and close equity gaps Source: Goldenberg RL, McClure EM, Bhutta ZA, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the vision for 2020. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62235-0. The Stillbirth Series Series 1. Fren JF, Cacciatore J, McClure EM, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: why they matter. Lancet 2011; published online April 14. DOI:10.1016/S01406736(10)62232-5. 2. Lawn JE, Blencowe H, Pattinson R, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: Where? When? Why? How to make the data count? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62187-3. 3. Bhutta ZA, Yakoob MY, Lawn JE, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: what difference can we make and at what cost? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62050-8. 4. Pattinson R, Kerber K, Buchmann E, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: how can health systems deliver for mothers and babies? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62306-9. 5. Flenady V, Middleton P, Smith GC, et al, for The Lancets Stillbirths Series steering committee.

Stillbirths: the way forward in high-income countries. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60064-0. 6. Goldenberg RL, McClure EM, Bhutta ZA, et al, for The Lancets Stillbirths Series steering committee. Stillbirths: the vision for 2020. Lancet 2011; published online April 14. DOI:10.1016/ S0140-6736(10)62235-0. The Stillbirth Series Articles Cousens S, Stanton C, Blencowe H, et al. National, regional, and worldwide estimates of stillbirth rates in 2009 with trends since 1995: a systematic analysis. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62310-0. Flenady V, Koopmans L, Middleton, et al. Major risk factors for stillbirth in high-income countries: a systematic review and meta-analysis. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62233-7. Executive summary of The Lancet Stillbirth Series Lawn JE, Kinney M, for The Lancets Stillbirths Series steering committee. The Lancets Stillbirths Series Executive summary. Lancet 2011; published online April 14. Translated version in Italian and French available online .

The Stillbirth Series Comments Mullan Z, Horton R. Bringing stillbirths out of the shadows. Lancet 2011; published online April 14, 2011. DOI:10.1016/S0140-6736(11)60098-6 Walker N. Plausible estimates of stillbirth rates. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(10)62355-0. Cnattingius S, Stephansson O.Reducing risk factors for stillbirth: wishful thinking? Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60027-5. Scott J. Stillbirth: breaking the silence of a hidden grief. Lancet 2011; published online April 14.

DOI: 0.1016/S0140-6736(11)60107-4. Serour GI, Cabral SA, Lynch B. Stillbirth: the professional organisations perspective. Lancet 2011; published online April 14. DOI:10.1016/ S0140-6736(11)60107-4. Darmstadt GL. Stillbirths: missing from the family and from family health. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60099-8. Spong CY, Reddy U, Willinger M. Addressing the complexity of disparities in stillbirth. Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60025-1. Kelley M. Counting stillbirths: womens health and reproductive rights.Lancet 2011; published online April 14. DOI:10.1016/S0140-6736(11)60107-4. Snapshot of stillbirth in UK Stillbirth data for the UK Number of stillbirths per year (2009) 2,630 Rank out of 193 countries numbers

115 Stillbirth rate per 1000 births (2009) 3.5 Rank out of 193 countries rates 33 Rate of reduction 1995-2009 1.4% -Placental problems -Congenital abnormalities

Priority actions: -Intrapartum causes 1. Reduce inequity, intentionally designing policies and programmes -Maternal disorders to reach underserved women from poor communities- or ethnic minorities Pre-eclampsia 2. Improve quality of care and use audit to link to change, and 3. Address lifestyle risk factors such as obesity,Infection smoking, and advanced Important causes Snapshot of stillbirth in USA Stillbirth data for the USA

Number of stillbirths per year (2009) 13,070 Rank out of 193 countries numbers 156 Stillbirth rate per 1000 births (2009) 3.0 Rank out of 193 countries rates 17

Rate of reduction 1995-2009 1.5% -Placental problems -Congenital abnormalities -Intrapartum causes Priority actions: 1. Reduce inequity, intentionally designing policies and programmes -Maternal disorders to reach underserved women from poor communities-Pre-eclampsia or ethnic minorities 2. Improve quality of care and use audit to link-Infection to change, and

Important causes 3. Address lifestyle risk factors such as obesity, smoking, and advanced Report card for stillbirths in South Africa Stillbirth data Number of stillbirths per year (2009), WHO definition Rank for numbers* Stillbirth rate per 1000 births (2009), WHO definition Rank for rates* * From 193 countries Av annual rate of reduction 19952009

2000-2009 progress 23,000 176 20 148 0.9% Stillbirth rate reduced from 23 to 20 per 1000 (12%, or <1%

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