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Thidar Pyone Vijay Singh G.C.

Cost Effectiveness Analysis of Oral Misoprostol (600 µg) for Preventing Maternal Deaths Due to Postpartum Haemorrhage (PPH) in Community Settings. Thidar Pyone Vijay Singh G.C. 15 June 2010. Postpartum Haemorrhage (PPH).

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Thidar Pyone Vijay Singh G.C.

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  1. Cost Effectiveness Analysis of Oral Misoprostol (600 µg) for Preventing Maternal Deaths Due to Postpartum Haemorrhage (PPH) in Community Settings Thidar Pyone Vijay Singh G.C. 15 June 2010

  2. Postpartum Haemorrhage (PPH) • During childbirth, after delivery of the foetus, there is placental separation from the uterus resulting in haemorrhage. • Normal amount of blood loss 200-300 ml • Severity depends on the haemoglobin level of a woman & worsened in anaemia and/or presence of malaria

  3. Types & Problems of PPH • Immediate PPH: within 24 hours after childbirth • Delayed or secondary PPH: between second and 42 day of delivery • A major cause of morbidity and mortality in developing countries (a quarter of maternal deaths are due to haemorrhage) • The quickest of maternal killers as postpartum bleeding can kill even a healthy woman within 2hrs

  4. Common Practices to Prevent PPH • Injectable oxytocin • Oral Misoprostol (clinical and rural settings) • Active Management of Third Stage Labour (AMTSL) in clinical settings: a package of interventions involving application of uterotonic drugs, CCT-controlled cord traction and fundal massage • Timely referral to Emergency Obstetric Care (EmOC) • Breast feeding and nipple stimulation

  5. Rationales of using Misoprostol • Well established uterotonic effects • Is heat-stable, easy to administer (oral), feasible especially for home birth situation with no skilled attendants • Pragmatic and suitable for settings with >50% of women without skilled birth attendants • Common side effects: shivering and pyrexia are transient, self-limiting

  6. Current recommendations for PPH Prevention • WHO recommends the use of Misoprostol in the setting where there is no alternative uterotonics in home birth situations where there is no skilled birth attendant and no AMTSL • The International Federation of Midwives (ICM) and International Federation of Gynaecologists and Obstetricians (FIGO) also suggests for oral misoprostol where oxytocin is not available

  7. Study Setting

  8. Morang • Skilled birth attendants rate 18.7% • 65 Village Development Committees (VDCs) and 1 sub-metropolitan city with 999,789 popln. • Each VDC has either Sub Health Post (SHP) or Health Post (HP) or Primary Healthcare Centre (PHCC). • 24,312/year expected pregnancies in 65 VDCs • Sub-metropolitan city is excluded • Randomly selected 32 out of 65 VDCs for misoprostol intervention

  9. Intervention • Training of Female Community Health Volunteers (FCHVs) to distribute oral Misoprostol • If haemorrhage continues, look for other causes of haemorrhage and preparation for referral to nearest EmOC • Blood loss of ≥ 500 ml

  10. Methods • Primary outcome of interest – prevention of PPH • Decision-tree model • Direct cost of intervention were calculated over one year time horizon • Cost of intervention was estimated at each state • Recurrent cost of 5% • Employed DALY as one measure for effectiveness

  11. Assumptions • Transportation will be available for both areas at a cost • Direct costs were estimated from 2009 costs in USD (1 USD = NPR 73) • Cost of lost productivity and intangible costs were ignored • After training, all FCHVs will be able to identify pregnant woman, provide prenatal health education, dispense misoprostol (three 200 µg tabs) late in pregnancy, and make early postnatal visit

  12. Alive (p=1) Improve (p=0.85) PPH (p=0.064) Die Alive (p=0.975) Not-Improve (p=0.15) EmOC Misoprostol Die (p=0.025) Alive (p=1) No-PPH (p=0.936) Die Pregnant women Alive (p=0.975) EmOC PPH (p=0.12) Die (p=0.025) Standard care Alive (p=1) No-PPH (p=0.88) Die Model

  13. Costs

  14. Trial Profile

  15. Effect • DALYs = years of life lost due to death (YLL) + years of life lost due to disability (YLD) • YLL based on mean age of maternal death 35 years, 3% discounting • YLD were calculated WHO Global burden of disease metrics with score of 0.093

  16. Cost-Effectiveness Ratio • Univariate sensitivity analysis provided lower and upper estimation of ICER based on alternative estimation of PPH incidence probability

  17. Limitations • Costs are not adjusted for the inflation • The cost and effects of EmOC were not simulated in this analysis • The costs of logistics, storage and distribution were not considered • Nature of mortality parameter, blood loss and limiting haemorrhage deaths to those attributed to PPH

  18. Conclusion • Provision of Misoprostol to community level through FCHV was effective in reducing maternal mortality in preventing post partum haemorrhage (PPH) than standard care of third stage of labour. • Given the fact that only 18.7% of women in Nepal access to SBA at birth, Misoprostol is cost-effective, context-specific and pragmatic solution for maternal mortality due to PPH.

  19. References-1: • Borghi, J., Ensor, T., Neupane, B. D. & Tiwari, S. (2004) Coping with the Burden of the Costs of Maternal Health. Kathmandu, Nepal, Nepal Safer Motherhood Project. • Borghi, J., Ensor, T., Neupane, B. D. & Tiwari, S. (2006) Financial implications of skilled attendance at delivery in Nepal. Tropical Medicine & International Health, 11(2), 228-237. • Central Bureau of Statistics (2008) Nepal in Figures 2008. Kathmandu, Central Bureau of Statistics, National Planning Commission Secretariat, Government of Nepal. • Creinin, M. D., Shore, E., Balasubramanian, S. & Harwood, B. (2005) The true cost differential between mifepristone and misoprostol and misoprostol-alone regimens for medical abortion. Contraception, 71(1), 26-30. • District Public Health Office (DPHO) Morang (2008) Annual Report Fiscal Year 2064/65 (2007/2008). Biratnagar, District Public Health Office, Morang. • Family Health Division (1998) Maternal Mortality and Morbidity Study. Kathmandu, Family Health Division, Department of Health Services, Ministry of Health and Population (Nepal). • Ministry of Health and Population (MoHP) [Nepal], New ERA & Macro International Inc. (2007) Nepal Demographic and Health Survey 2006. Kathmandu, Nepal, Ministry of Health and Population, New ERA, and Macro International Inc. • Rajbhandari, S., Hodgins, S., Sanghvi, H., McPherson, R., Pradhan, Y. V. & Baqui, A. H. (2010) Expanding uterotonic protection following childbirth through community-based distribution of misoprostol: Operations research study in Nepal. International Journal of Gynecology & Obstetrics, 108(3), 282-288. • Sutherland, T. & Bishai, D. M. (2009) Cost-effectiveness of misoprostol and prenatal iron supplementation as maternal mortality interventions in home births in rural India. International Journal of Gynecology & Obstetrics, 104(3), 189-193. • Suvedi, B. K., Pradhan, A., Barnett, S., Puri, M., Chitrakar, S. R., Poudel, P., Sharma, S. & Hulton, L. (2009) Nepal Maternal Mortality and Morbidity Study 2008/2009: Summary of Preliminary Findings. Kathmandu, Nepal, Family Health division, Department of Health Services, Ministry of Health, Government of Nepal.

  20. References-2 • Alfirevic, Z., Blum, J., Walraven, G., Weeks, A. & Winikoff, B. (2007) Prevention of postpartum hemorrhage with misoprostol. International Journal of Gynaecology & Obstetrics, 99 Suppl 2, S198-201. • Derman, R. J., Kodkany, B. S., Goudar, S. S., Geller, S. E., Naik, V. A., Bellad, M. B., Patted, S. S., Patel, A., Edlavitch, S. A., Hartwell, T., Chakraborty, H. & Moss, N. (2006) Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet, 368(9543), 1248-53. • Elati, A. & Weeks, A. (2009) The use of misoprostol in obstetrics and gynaecology. BJOG: An International Journal of Obstetrics & Gynaecology, 116(s1), 61-69. • Festin, M. R., Lumbiganon, P., Tolosa, J. E., Finney, K. A., Ba-Thike, K., Chipato, T., Gaitan, H., Xu, L., Limpongsanurak, S., Mittal, S., Peedicayil, A., Pramono, N., Purwar, M., Shenoy, S. & Daly, S. (2003) International survey on variations in practice of the management of the third stage of labour. Bulletin of the World Health Organization, 81(4), 286-91. • Geller, S. E., Adams, M. G., Kelly, P. J., Kodkany, B. S. & Derman, R. J. (2006) Postpartum hemorrhage in resource-poor settings. International Journal of Gynaecology & Obstetrics, 92(3), 202-11. • Gulmezoglu, A. M., Villar, J., Ngoc, N. T., Piaggio, G., Carroli, G., Adetoro, L., Abdel-Aleem, H., Cheng, L., Hofmeyr, G., Lumbiganon, P., Unger, C., Prendiville, W., Pinol, A., Elbourne, D., El-Refaey, H. & Schulz, K. (2001) WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. Lancet, 358(9283), 689-95. • Hill, K., Thomas, K., AbouZahr, C., Walker, N., Say, L., Inoue, M. & Suzuki, E. (2007) Estimates of maternal mortality worldwide between 1990 and 2005: an assessment of available data. Lancet, 370(9595), 1311-19. • Hofmeyr, G. J. & Gulmezoglu, A. M. (2008) Misoprostol for the prevention and treatment of postpartum haemorrhage. Best Practice & Research Clinical Obstetrics and Gynaecology, 22(6), 1025-41. • International Confederation of Midwives (ICM), International Federation of Gynaecologists and Obstetricians (FIGO) (2004) Joint statement: management of the third stage of labour to prevent post-partum haemorrhage Journal of Midwifery & Women's Health 49(1), 76-77. • Khan, K. S., Wojdyla, D., Say, L., Gulmezoglu, A. M. & Van Look, P. F. (2006) WHO analysis of causes of maternal death: a systematic review. Lancet, 367(9516), 1066-74. • Maine, D. & Rosenfield, A. (1999) The Safe Motherhood Initiative: why has it stalled? Americal Journal of Public Health, 89(4), 480-2.

  21. References-3 • Mathai, M. (2006) The Epidemiology of Postpartum Haemorrhage. IN Sanghvi, H. & Lewison, D. (Eds.) Preventing Mortality from Postpartum Haemorrhage in Africa: Moving from Research to Practice. Report of a conference in Entebbe, Uganda, 4-7 April 2006, JHPIEGO, Baltimore, Maryland. • McNeilly, A. S., Robinson, I. C., Houston, M. J. & Howie, P. W. (1983) Release of oxytocin and prolactin in response to suckling. British Medical Journal (Clin Res Ed), 286(6361), 257-9. • Ng, P. S., Chan, A. S., Sin, W. K., Tang, L. C., Cheung, K. B. & Yuen, P. M. (2001) A multicentre randomized controlled trial of oral misoprostol and i.m. syntometrine in the management of the third stage of labour. Human Reproduction, 16(1), 31-35. • Pagel, C., Lewycka, S., Colbourn, T., Mwansambo, C., Meguid, T., Chiudzu, G., Utley, M. & Costello, A. M. (2009) Estimation of potential effects of improved community-based drug provision, to augment health-facility strengthening, on maternal mortality due to post-partum haemorrhage and sepsis in sub-Saharan Africa: an equity-effectiveness model. Lancet, 374(9699), 1441-8. • Patted, S. S., Goudar, S. S., Naik, V. A., Bellad, M. B., Edlavitch, S. A., Kodkany, B. S., Patel, A., Chakraborty, H., Derman, R. J. & Geller, S. E. (2009) Side effects of oral misoprostol for the prevention of postpartum hemorrhage: results of a community-based randomised controlled trial in rural India. Journal of Maternal-Fetal and Neonatal Medicine, 22(1), 24-8. • Rajbhandari, S., Hodgins, S., Sanghvi, H., McPherson, R., Pradhan, Y. V. & Baqui, A. H. (2010) Expanding uterotonic protection following childbirth through community-based distribution of misoprostol: Operations research study in Nepal. International Journal of Gynecology & Obstetrics, 108(3), 282-288. • Ronsmans, C. & Graham, W. J. (2006) Maternal mortality: who, when, where, and why. Lancet, 368(9542), 1189-200. • Strand, R. T., Da Silva, F., Jangsten, E. & Bergstrom, S. (2005) Postpartum hemorrhage: a prospective, comparative study in Angola using a new disposable device for oxytocin administration. Acta Obstetricia et Gynecologica Scandinavica, 84(3), 260-5. • Villar, J., Gulmezoglu, A. M., Hofmeyr, G. J. & Forna, F. (2002) Systematic review of randomized controlled trials of misoprostol to prevent postpartum hemorrhage. Obstetrics & Gynecology, 100(6), 1301-12. • Walraven, G., Blum, J., Dampha, Y., Sowe, M., Morison, L., Winikoff, B. & Sloan, N. (2005) Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial. BJOG: An International Journal of Obstetrics & Gynaecology, 112(9), 1277-83. • World Health Organization (2005) World Health Report 2005: make every mother and child count. Geneva, Switzerland, World Health Organization. • World Health Organization (2009) WHO Statement regarding the use of misoprostol for postpartum haemorrhage prevention and treatment (WHO/RHR/09.22 ). [Online] Available from: http://whqlibdoc.who.int/hq/2009/WHO_RHR_09.22_eng.pdf [Accessed: 30 May 2010].

  22. Thank you.

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