Effect on Postpartum Hemorrhage of Prophylactic Oxytocin (10 IU) by Injection by Community Health Officers in Ghana: A Community-Based, Cluster-Randomized Trial

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Background:
Oxytocin (10 IU) is the drug of choice for prevention of postpartum hemorrhage (PPH). Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births.

Methods and Findings:
This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km) to intervention (one injection of oxytocin [10 IU] one minute after birth) and control (no provision of prophylactic oxytocin) arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1) blood loss ≥500 mL; (PPH-2) PPH-1 plus women who received early treatment for PPH; and (PPH-3) PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27–0.88); PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18–0.63), and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7–72.6) less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls.

Conclusion:
Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births.

Trial registration:
ClinicalTrials.gov NCT01108289

Please see later in the article for the Editors' Summary

Vyšlo v časopise: Effect on Postpartum Hemorrhage of Prophylactic Oxytocin (10 IU) by Injection by Community Health Officers in Ghana: A Community-Based, Cluster-Randomized Trial. PLoS Med 10(10): e32767. doi:10.1371/journal.pmed.1001524
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1001524

Souhrn

Conclusion:
Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births.

Trial registration:
ClinicalTrials.gov NCT01108289

Please see later in the article for the Editors' Summary

Zdroje

1. KhanKS, WojdylaD, SayL, GulmezogluAM, Van LookPF (2006) WHO analysis of causes of maternal death: a systematic review. Lancet 367: 1066–1074.

2. World Health Organization, United Nations Children's Fund, United Nations Fund for Population Activities, The World Bank (2012) Trends in maternal mortality: 1990–2010. Geneva.

3. United Nations Children's Fund (2000) State of the Word's Children. New York, UNICEF.

4. United Nations Children's Fund (2012) State of the World's Children. New York, UNICEF.

5. World Health Organization (2007) WHO recommendations for the prevention and treatment of postpartum haemorrhage. Geneva: Department of Reproductive Health, WHO.

6. World Health Organization (2010) Clarifying the WHO position on misoprostol use in the community to reduce maternal death. Geneva: Department of Reproductive Health, WHO.

7. World Health Organization (2012) WHO recommendations for the prevention and treatment of postpartum haemorrhage. Geneva: Department of Reproductive Health, WHO.

8. CotterAN, TolosaA, (2010) Prophylactic oxytocin for the third stage of labour. Cochrane Library

9. World Health Organization (2012) WHO recommendations Optimizing health worker roles to increase access to key maternal and newborn health interventions through task shifting. Geneva: Department of Reproductive Health, WHO.

10. DermanRJ, KodkanyBS, GoudarSS, GellerSE, NaikVA, et al. (2006) Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet 368: 1248–1253.

11. MobeenN, DurocherJ, ZuberiN, JahanN, BlumJ, et al. (2011) Administration of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a randomised placebo-controlled trial. BJOG 118: 353–361.

12. HojL, CardosoP, NielsenBB, HvidmanL, NielsenJ, et al. (2005) Effect of sublingual misoprostol on severe postpartum haemorrhage in a primary health centre in Guinea-Bissau: randomised double blind clinical trial. BMJ 331: 723.

13. World Health Organization (2000) Managing Complications of Pregnancy and Childbirth; A guide for midwives and doctors. Geneva: Department of Reproductive Health, WHO.

14. Hogerzeil HV WGJA, de Goeje MJ (1993) Stability of injectable oxytocics in tropical climates: Results of field surveys and simulation studies on ergometrine, methylergometrine and oxytocin. Geneva: World Health Organization Action Programme on Essential Drugs.

15. PatelA, GoudarSS, GellerSE, KodkanyBS, EdlavitchSA, et al. (2006) Drape estimation vs. visual assessment for estimating postpartum hemorrhage. Int J Gynaecol Obstet 93: 220–224.

16. StantonCK, NewtonS, MullanyLC, CofieP, AgyemangCT, et al. (2012) Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject by peripheral health care providers at home births: design of a community-based cluster-randomized trial. BMC Pregnancy Childbirth 12: 42.

17. KirkwoodBR, HurtL, Amenga-EtegoS, TawiahC, ZandohC, et al. (2010) Effect of vitamin A supplementation in women of reproductive age on maternal survival in Ghana (ObaapaVitA): a cluster-randomised, placebo-controlled trial. Lancet 375: 1640–1649.

18. ICF International (2013) Ghana Demographic and Health Surveys Final Country Reports, 1993–2008. Available: http://www.statcompiler.com/. Accessed 14 April 2013.

19. TsuVMT, NguyenY, LuuH (2006) Reducing postpartum hemorrhage in Vietnam: Assessing the effectiveness of active management of third-stage labor. J Obstet Gynaecol Res 32: 489–496.

20. TsuVLH, MaiT (2009) Does a novel prefilled injection device make postpartum oxytocin easier to administer? Results from midwives in Vietnam. Midwifery 25: 461–465.

21. AlthabeFVA, CafferataM, GibbonsL, KarolinskiA, ArmbrusterD, BuekensP, BelizanJ (2011) Using Uniject to increase the use of prophylactic oxytocin for management of the third stage of labor in Latin America. Int J Gynaecol Obstet 114: 184–189.

22. TsuVSA, VaidyaK (2003) Oxytocin in prefilled Uniject injection devices for managing third-stage labor in Indonesia. Int J Gynaecol Obstet 83: 103–111.

23. LiangK, ZegerSL (1986) Longitudinal data analysis using generalized linear models. Biometrika 73: 13–22.

24. United Nations Commission on Life-saving Commodities for Women and Children (2012) United Nations Commission on Life-savng Commodities for Women and Children; Commissioners' Report 2012. New York, United Nations Commission on Life-saving Commodies for Women and Children.