A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial

BMC Medicine

Robert L Goldenberg^1,13  Suzanne Stalls^1,17  Dennis D Wallace⁴  Marion Koso-Thomas^1,16  Alan H Jobe⁸  Janet Moore⁴  Pierre Buekens^1,15  K Michael Hambidge^1,11  Nancy Krebs^1,11  Edward K Liechty⁷  Patricia L Hibberd^1,12  Richard J Derman²  Waldemar A Carlo⁵  Albert Manasyan^1,14  Hillary Mabeya³  Bhala Kodkany⁶  Fernando Althabe^1,18  Ana Garces^2,20  Fabian Esamai³  Archana Patel¹  Elwyn Chomba⁹  Shivaprasad S Goudar⁶  Sarah Saleem^1,19  Linda L Wright^1,16  Elizabeth M McClure^1,10  Omrana Pasha^1,19 

[1] Indira Gandhi Government Medical College, Nagpur, India;Christiana Care Health Services, Newark, DE, USA;Moi University School of Medicine, Eldoret, Kenya;Research Triangle Institute, Durham, NC, USA;University of Alabama at Birmingham, Birmingham, AL, USA;KLE University’s Jawaharlal Nehru Medical College, Belgaum, India;Indiana University, Indianapolis, IN, USA;University of Cincinnati, Cincinnati, OH, USA;Department of Pediatrics, University Teaching Hospital, Lusaka, Zambia;Department of Social, Statistical and Environmental Sciences, Research Triangle Institute, Durham, NC, USA;University of Colorado, Denver, CO, USA;Massachusetts General Hospital for Children, Boston, MA, USA;Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA;Centre for Infectious Disease Research Zambia, Lusaka, Zambia;School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA;Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA;American College of Nurse Midwives, Washington, DC, USA;Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina;Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan;Francisco Marroquin University, Guatemala City, Guatemala

关键词: Emergency obstetric care;    Maternal mortality;    Neonatal mortality;    Stillbirth;   

Others  :  855670
DOI  :  10.1186/1741-7015-11-215

 received in 2013-04-30, accepted in 2013-09-16,  发布年份 2013

【 摘 要 】

Background

Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care.

Methods

This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g.

Results

Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention.

Conclusions

This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be.

Trial registration

ClinicalTrials.gov NCT01073488

【 授权许可】

   
2013 Pasha et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Ronsmans C, Graham WJ: Maternal morality: who, where, when, and why. Lancet 2006, 368:1189-1200.
• [2]AbouZahr C: Global burden of maternal death and disability. Br Med Bull 2003, 67:1-11.
• [3]Lawn JE, Kinney M, Lee AC, Chopra M, Donnay F, Paul VK, Bhutta ZA, Bateman M, Darmstadt GL: Reducing intrapartum-related deaths and disability: Can the health system deliver? Int J Gynaecol Obstet 2009, 107:S123-S140. S140-142
• [4]Cousens S, Blencowe H, Stanton C, Chou D, Ahmed S, Steinhardt L, Creanga AA, Tunçalp O, Balsara ZP, Gupta S, Say L, Lawn JE: National, regional, and worldwide estimates of stillbirth rates in 2009 with trends since 1995: a systematic analysis. Lancet 2011, 377:1319-1330.
• [5]McClure EM, Goldenberg RL, Bann CM: Maternal mortality, stillbirth and measures of obstetric care in developing and developed countries. Int J Gynaecol Obstet 2007, 96:139-146.
• [6]Oestergaard MZ, Inoue M, Yoshida S, Mahanani WR, Gore FM, Cousens S, Lawn JE, Mathers CD, United Nations Inter-Agency Group for Child Mortality Estimation and the Child Health Epidemiology Reference Group: Neonatal mortality levels for 193 countries in 2009 with trends since 1990: a systematic analysis of progress, projections, and priorities. PLoS Med 2011, 8:e1001080.
• [7]UNICEF: State of the World’s Children. New York, NY: UNICEF; 2009.
• [8]Lawn JE, Kinney MV, Black RE, Pitt C, Cousens S, Kerber K, Corbett E, Moran AC, Morrissey CS, Oestergaard MZ: Newborn survival: a multi-country analysis of a decade of change. Health Policy Plan 2012, 27:iii6-iii28.
• [9]Mir AM, Gull S: Countdown to 2015: A case study of maternal and child health service delivery challenges in five districts of Punjab. J Pak Med Assoc 2012, 62:1308-1313.
• [10]Darmstadt GL, Lee AC, Cousens S, Sibley L, Bhutta ZA, Donnay F, Osrin D, Bang A, Kumar V, Wall SN, Baqui A, Lawn JE: 60 million non-facility births: who can deliver in community settings to reduce intrapartum-related deaths? Int J Gynaecol Obstet 2009, 107:S89-S112.
• [11]Campbell OM, Graham WJ: Lancet Maternal Survival Series Steering Group. Strategies for reducing maternal mortality: getting on with what works. Lancet 2006, 368:1284-1299.
• [12]Penny S, Murray SF: Training initiatives for essential obstetric care in developing countries: a 'state of the art’ review. Health Policy Plan 2000, 15:386-393.
• [13]Gabrysch S, Campbell OM: Still too far to walk: literature review of the determinants of delivery service use. BMC Pregnancy Childbirth 2009, 9:34. BioMed Central Full Text
• [14]Derman RJ, Kodkany BS, Goudar SS, Geller SE, Naik VA, Bellad MB, Patted SS, Patel A, Edlavitch SA, Hartwell T, Chakraborty H, Moss N: Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet 2006, 368:1248-1253.
• [15]Fournier P, Dumont A, Tourigny C, Dunkley G, Dramé S: Improved access to comprehensive emergency obstetric care and its effect on institutional maternal mortality in rural Mali. Bull World Health Organ 2009, 87:30-38.
• [16]Pattinson R, Kerber K, Buchmann E, Friberg IK, Belizan M, Lansky S, Weissman E, Mathai M, Rudan I, Walker N, Lawn JE, Lancet's Stillbirths Series steering committee: Stillbirths: how can health systems deliver for mothers and babies? Lancet 2011, 377:1610-1623.
• [17]Jokhio AH, Winter HR, Cheng KK: An intervention involving traditional birth attendants and perinatal and maternal mortality in Pakistan. N Engl J Med 2005, 352:2091-2099.
• [18]O’Rourke K, Howard-Grabman L, Seoane G: Impact of community organization of women on perinatal outcomes in rural Bolivia. Rev Panam Salud Publica 1998, 3:9-14.
• [19]Bang AT, Reddy HM, Deshmukh MD, Baitule SB, Bang RA: Neonatal and infant mortality in the ten years (1993 to 2003) of the Gadchiroli field trial: effect of home-based neonatal care. J Perinatol 2005, 25:S92-S107.
• [20]Tripathy P, Nair N, Barnett S, Mahapatra R, Borghi J, Rath S, Gope R, Mahto D, Sinha R, Lakshminarayana R, Patel V, Pagel C, Prost A, Costello A: Effect of a participatory intervention with women’s groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster-randomised controlled trial. Lancet 2010, 375:1182-1192.
• [21]Azad K, Barnett S, Banerjee B, Shaha S, Khan K, Rego AR, Barua S, Flatman D, Pagel C, Prost A, Ellis M, Costello A: Effect of scaling up women’s groups on birth outcomes in three rural districts in Bangladesh: a cluster-randomised controlled trial. Lancet 2010, 375:1193-1202.
• [22]Manandhar DS, Osrin D, Shrestha B, Mesko N, Morrison J, Tumbahangphe KM, Tamang S, Thapa S, Shrestha D, Thapa B, Shrestha JR, Wade A, Borghi J, Standing H, Manandhar M, Costello AM, Members of the MIRA Makwanpur trial team: Effect of a participatory intervention with women’s groups on birth outcomes in Nepal: cluster-randomised controlled trial. Lancet 2004, 364:970-979.
• [23]Fullerton JT, Killian R, Gass PM: Outcomes of a community- and home-based intervention for safe motherhood and newborn care. Health Care Women Int 2007, 26:561-576.
• [24]Sibley LM, Sipe TA: Transition to skilled birth attendance: Is there a future role for trained traditional birth attendants? J Health Popul Nutr 2006, 24:472-478.
• [25]Sibley LM, Sipe TA, Barry D: Traditional birth attendant training for improving health behaviours and pregnancy outcomes. Cochrane Database of Syst Rev 2012., 8Art. No.: CD005460
• [26]Carlo WA, Goudar SS, Jehan I, Chomba E, Tshefu A, Garces A, Parida S, Althabe F, McClure EM, Derman RJ, Goldenberg RL, Bose C, Krebs NF, Panigrahi P, Buekens P, Chakraborty H, Hartwell TD, Wright LL, First Breath Study Group: Newborn-care training and perinatal mortality in developing countries. N Engl J Med 2010, 362:614-623.
• [27]Pattinson R, Kerber K, Waiswa P, Day LT, Mussell F, Asiruddin SK, Blencowe H, Lawn JE: Perinatal mortality audit: counting, accountability, and overcoming challenges in scaling up in low- and middle-income countries. Int J Gynaecol Obstet 2009, 107:S113-S121. S121-2
• [28]Goudar SS, Carlo WA, McClure EM, Pasha O, Patel A, Esamai F, Chomba E, Garces A, Althabe F, Kodkany B, Sami N, Derman RJ, Hibberd PL, Liechty EA, Krebs NF, Hambidge KM, Buekens P, Moore J, Wallace D, Jobe AH, Koso-Thomas M, Wright LL, Goldenberg RL: The maternal and newborn health registry study of the Global Network for Women’s and Children’s Health Research. Int J Gynaec Obstet 2012, 118:190-193.
• [29]Manasyan A, Saleem S, Koso-Thomas M, Althabe F, Pasha O, Chomba E, Goudar SS, Patel A, Esamai F, Garces A, Kodkany B, Belizan J, McClure EM, Derman RJ, Hibberd P, Liechty EA, Hambidge KM, Carlo WA, Buekens P, Moore J, Wright LL, Goldenberg R, EmONC Trial Group: Assessment of obstetric and neonatal health services in developing country health facilities. Am J Perinatol 2013, 30:787-794.
• [30]Pasha O, Goldenberg RL, McClure EM, Saleem S, Goudar SS, Althabe F, Patel A, Esamai F, Garces A, Chomba E, Mazariegos M, Kodkany B, Belizan JM, Derman RJ, Hibberd PL, Carlo WA, Liechty EA, Hambidge KM, Buekens P, Wallace D, Howard-Grabman L, Stalls S, Koso-Thomas M, Jobe AH, Wright LL: Communities, birth attendants and health facilities: a continuum of emergency maternal and newborn care (The Global Network’s EmONC Trial). BMC Pregnancy Childbirth 2010, 10:82. BioMed Central Full Text
• [31]Buffington S, Sibley L, Beck D, Armbruster D: Home Based Life Saving Skills. Washington (DC): American College of Nurse Midwives; 2004.
• [32]Ronsmans C, Endang A, Gunawan S, Zazri A, McDermott J, Koblinsky M, Marshall T: Evaluation of a comprehensive home-based midwifery programme in South Kalimantan, Indonesia. Trop Med Int Health 2001, 6:799-810.
• [33]Sibley L, Buffington ST, Beck D, Armbruster D: Home based life saving skills: promoting safe motherhood through innovative community-based interventions. J Midwifery Womens Health 2001, 46:258-266.
• [34]Fullerton JT, Killian R, Gass PM: Outcomes of a community- and home-based intervention for safe motherhood and newborn care. Health Care Women Int 2005, 26:561-576.
• [35]Lori JR, Majszak CM, Martyn KK: Home-based life-saving skills in Liberia: acquisition and retention of skills and knowledge. J Midwifery Womens Health 2010, 55:370-377.
• [36]Lori JR, Amable EE, Mertz SG, Moriarty K: Behavior change following implementation of home-based life-saving skills in Liberia, West Africa. J Midwifery Womens Health 2012, 57:495-501.
• [37]Emergency Obstetric Care for Doctors and Midwives Jhpiego/MNH Program and AMDD Program, Columbia University. [http://reprolineplus.org/resources/trainer-educator/learning-resource-packages webcite]
• [38]Partamin , Kim YM, Mungia J, Faqir M, Ansari N, Evans C: Patterns in training, knowledge, and performance of skilled birth attendants providing emergency obstetric and newborn care in Afghanistan. Int J Gynaecol Obstet 2012, 119:125-129.
• [39]Dumont A, Gaye A, de Bernis L, Chaillet N, Landry A, Delage J, Bouvier-Colle MH: Facility-based maternal death reviews: effects on maternal mortality in a district hospital in Senegal. Bull World Health Organ 2006, 84:218-224.