Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via UnijectTM by peripheral health care providers at home births: design of a community-based cluster-randomized trial

BMC Pregnancy and Childbirth

Seth Owusu-Agyei¹  Deborah Armbruster⁴  John Gyapong⁷  Alice Levisay⁵  Sadaf Khan⁵  Niamh Darcy²  Edward Adiibokah¹  Charlotte Tawiah Agyemang¹  Patience Cofie³  Luke C Mullany⁶  Samuel Newton¹  Cynthia K Stanton⁶ 

[1] Kintampo Health Research Centre, Kintampo, Ghana;Research Triangle Institute, Research Triangle, North Carolina, USA;PATH, Accra, Ghana;United States Agency for International Development, formerly of PATH, Washington, DC, USA;PATH, Seattle, Washington, USA;Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA;University of Ghana, formerly of Ghana Health Service, Health Research Unit, Accra, Ghana

关键词: randomized trial;    uterotonics;    oxytocin;    Postpartum hemorrhage;   

Others  :  1152853
DOI  :  10.1186/1471-2393-12-42

 received in 2011-12-02, accepted in 2012-06-07,  发布年份 2012

【 摘 要 】

Background

Hemorrhage is the leading direct cause of maternal death globally. While oxytocin is the drug of choice for postpartum hemorrhage prevention, its use has generally been limited to health facilities. This trial assesses the effectiveness, safety, and feasibility of expanding the use of prophylactic intramuscular oxytocin to peripheral health care providers at home births in four predominantly rural districts in central Ghana.

Methods

This study is designed as a community-based cluster-randomized trial in which Community Health Officers are randomized to provide (or not provide) an injection of oxytocin 10 IU via the Uniject^TM injection system within one minute of delivery of the baby to women who request their presence at home at the onset of labor. The primary aim is to determine if administration of prophylactic oxytocin via Uniject™ by this cadre will reduce the risk of postpartum hemorrhage by 50 % relative to deliveries which do not receive the prophylactic intervention. Postpartum hemorrhage is examined under three sequential definitions: 1) blood loss ≥500 ml (BL); 2) treatment for bleeding (TX) and/or BL; 3) hospital referral for bleeding and/or TX and/or BL. Secondary outcomes address safety and feasibility of the intervention and include adverse maternal and fetal outcomes and logistical concerns regarding assistance at home births and the storage and handling of oxytocin, respectively.

Discussion

Results from this trial will build evidence for the effectiveness of expanding the delivery of this established prophylactic intervention to peripheral settings. Complementary data on safety and logistical issues related to this intervention will assist policymakers in low-income countries in selecting both the best uterotonic and service delivery strategy for postpartum hemorrhage prevention. Results of this trial are expected in mid-2013. The trial is registered at ClinicalTrials.gov: NCT01108289.

【 授权许可】

   
2012 Stanton et al. licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

Figure 4.

Figure 5.

【 参考文献 】

• [1]Hogan MC, Foreman KJ, Naghavi M, et al.: Maternal mortality for 181 countries, 1980–2008: a systematic analysis of progress towards Millennium Development Goal 5. Lancet 2010, 375(9726):1609-1623.
• [2]Khan KS, Wojdyla D, Say L, et al.: WHO analysis of causes of maternal death: a systematic review. Lancet 2006, 367(9516):1066-1074.
• [3]Prendiville WJ, Elbourne D, McDonald S: Active versus expectant management in the third stage of labour. Cochrane Database Syst Rev 2000, 2:000007.
• [4]WHO: WHO Recommendations for the Prevention of Postpartum Haemorrhage. 2007.
• [5]FIGO, ICM: Joint Statement. The Hague, London; 2003.
• [6]Mathai M, Gulmezoglu AM, Hill S: Saving womens lives: evidence-based recommendations for the prevention of postpartum haemorrhage. Bull World Health Organ 2007, 85(4):322-323.
• [7]Walraven G, Blum J, Dampha Y, et al.: Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial. BJOG 2005, 112(9):1277-1283.
• [8]Høj L, Placido C, Bruun B, et al.: Effect of sublingual misoprostol on severe postpartum haemorrhage in a primary health centre in Guinea-Bissau: randomised double blind clinical trial. BMJ 2005, 331(7519):723.
• [9]Derman RJ, Kodkany BS, Goudar SS, et al.: Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet 2006, 368(9543):1248-1253.
• [10]Gulmezoglu AM, Villar F, Hofmeyr GJ: Prostaglandins for postpartum haemorrhage (Cochrane Review). The Cochrane Library 2004., 3
• [11]Buekens P, Althabe F: Post-partum haemorrhage: beyond the confrontation between misoprostol and oxytocin. Lancet 2010, 375(9710):176-178.
• [12]PATH: A HealthTech Historical Profile. The Uniject Device, Seattle; 2005.
• [13]Strand RT, et al.: Postpartum hemorrhage: a prospective, comparative study in Angola using a new disposable device for oxytocin administration. Acta Obstet Gynecol Scand 2005, 84(3):260-265.
• [14]Jangsten ES, Strand R: Gomez de Freitas E, Hellstrom A, Johansson A, Bergstrom S: Women's perceptions of pain and discomfort after childbirth in Angola. African Journal of Reproductive Health 2005, 9(3):148-158.
• [15]Althabe FM, Mazzoni A, Cafferata M, Gibbons L, Karolinski A, Armbruster D, Buekens P, Belizan J: Using Uniject ot increase the use of prophylactic oxtyocin for management of the third stage of labor in Latin America. Int J Gynaecol Obstet 2011, 114:184-189.
• [16]Tsu VD, Sutanto A, Vaidya K, et al.: Oxytocin in prefilled Uniject injection devices for managing third-stage labor in Indonesia. Int J Gynaecol Obstet 2003, 83(1):103-11.
• [17]POPPHI: Pilot use of oxytocin in a Uniject device for AMTSL in Mali. Evaluation of the safety and feasibility of a new delivery technology, Seattle; 2008.
• [18]Tsu VD, Mai T, Nguyen Y, Luu H: Reducing postpartum hemorrhage in Vietnam: Assessing the effectiveness of active management of third-stage labor. J Obstet Gynaecol Res 2006, 32(5):489-496.
• [19]Tsu VD, Luu H, Mai T: Does a novel prefilled injection device make postpartum oxytocin easier to administer? Results from midwives in Vietnam. Midwifery 2009, 25:461-465.
• [20]WHO Stability of injectable oxytocics in tropical climates, Geneva; 1993.
• [21]Kirkwood BR, Hurt L, Amenga-Etego S, et al.: Effect of vitamin A supplementation in women of reproductive age on maternal survival in Ghana (ObaapaVitA): a cluster-randomised, placebo-controlled trial. Lancet 2010, 375(9726):1640-1649.
• [22]Ryan P: Random allocation of treatments in blocks (sxd1_4). Stata Journal 2008, 8(4):594.
• [23]Patel A, Goudar SS, Geller SE, et al.: Drape estimation vs. visual assessment for estimating postpartum hemorrhage. Int J Gynaecol Obstet 2006, 93(3):220-224.
• [24]Hayes RJ, Moulton LH: Cluster Randomized Trials. Chapman & Hall/CRC, Boca Raton; 2009.
• [25]Zeger SL, Liang KY, Albert PS: Models for longitudinal data: a generalized estimating equation approach. Biometrics 1988, 44(4):1049-1060.
• [26]WHO: Managing Complications in Pregnancy and Childbirth. A guide for midwives and doctors, Geneva; 2000.
• [27]Konje JC, Odukoya OA, Ladipo OA: Ruptured uterus in Ibadan–a twelve year review. Int J Gynaecol Obstet 1990, 32(3):207-213.
• [28]Zheng Q: Analysis of 39 cases of maternal deaths caused by incorrect use of oxytocin. Zhonghua Fu Chan Ke Za Zhi 1994, 29(5):276-277. 316–317
• [29]Lan KK, DeMets DL: Discrete sequential boundaries for clinical trials: a generalized estimating equation approach. Biometrika 1983, 70:659-663.
• [30]O'Brien PF, Fleming TR: A multiple testing procedure for clinical trials. Biometrics 1979, 35(3):549-556.
• [31]Blum J, Winikoff B, Raghavan S, et al.: Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial. Lancet 2010, 375(9710):217-223.
• [32]Winikoff B, Dabash R, Durocher J, et al.: Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial. Lancet 2010, 375(9710):210-216.