Innovations to address postpartum haemorrhage in low

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Innovative interventions to address
postpartum haemorrhage in low-income
countries
Postpartum haemorrhage (PPH) is a common obstetric complication defined by the
World Health Organization (WHO) as blood loss of 500 ml or more 1. WHO states that
the loss of 500 ml of blood should be considered an alert, after which the health of
the woman may be endangered1. Haemorrhage, including PPH, is a leading cause of
death in developing countries, accounting for approximately one-third of all direct
obstetric deaths in Africa (33.9%) and Asia (30.8%)2. The Millennium Development
Goal 5 of reducing the maternal mortality ratio by 75% by 2015 will not be achieved
unless the prevention and treatment of PPH in low-resource areas is prioritised 3.
This table provides a summary of some of the innovative interventions used to
manage PPH in low-income countries. It highlights the advantages and disadvantages
of each intervention and critically assesses the evidence base available. These
interventions include oral misoprostol, a non-pneumatic anti-shock garment,
oxytocin in prefilled Uniject™ injection devices, and a hydrostatic intrauterine
balloon tamponade.
These innovations add to the range of interventions available to help prevent,
manage and/or treat PPH and improve health outcomes. These include the
administration of uteronics (e.g. oxytocin) or delayed cord clamping (for PPH
prevention), and intravenous uterine artery embolization or intravenous oxytocin or
ergometrine (for treatment of PPH)4.
Three key messages need to be considered in order to maximize the effectiveness of
interventions to address PPH. Firstly, preventing and treating PPH should take place
within a comprehensive package of interventions from the “household to hospital
continuum of care”4(p1). Secondly, even the most sophisticated PPH interventions can
only prevent maternal deaths if they are delivered within a functional health system.
Finally, blood transfusion is one of the most reliable strategies to respond to severe
bleeding as a result of PPH, particularly in the absence of other interventions. Blood
transfusions are an essential part of a comprehensive package of life saving
interventions used to manage obstetric complications5. An estimated 15% of all
births are expected to result in direct obstetric complications5, thus making it even
more important to ensure that safe blood transfusions are available.
1
Innovation
Oral
Misoprostol
[6]
Use
Prevent and treat PPH
Advantage

For PPH prevention, the WHO
recommends to use oral
misoprostol (600 µg) in
settings where oxytocin is not
available.
Alternative to oxytocin in
settings where this is
unavailable.
For treatment of PPH, the
WHO recommends using oral
misoprostol (800 µg) as a
second line treatment if
oxytocin is not effective.
Non-pneumatic
anti-shock
garment
(NASG)
[7-19]
Management of PPH and
Shock




The NASG reverses shock by
compressing the lower-body
vessels, decreasing the
container size of the body, so
circulating blood is directed
mainly to the core organs. It
also compresses the diameter
of pelvic blood vessels, thus
Disadvantage

Simple technology that can be
learned easily.
Does not take much shelf
space, is easy to clean, and is
reusable.
Device to stabilise women with
shock until definitive
treatments can be given – very
good for referrals.


Evidence
There are concerns regarding
the community-level
distribution of misoprostol and
the potential for serious
consequences if administered
before birth. It is therefore
advised to train persons
administering misoprostol and
monitor community
distribution interventions with
scientifically sound methods
and appropriate indicators.
Some members of the
Guideline Development Group
(GDG) felt that there might be a
risk of hyperpyrexia associated
to the dosage of 800 μg dose of
misoprostol for the treatment
of PPH.

Unlikely to cause harm.
Needs financial input.


Moderate quality evidence for
prevention according to the GDG.
Low-quality evidence for treatment
according to the GDG.
A definitive trial of the NASG for use
prior to transport from lower-level
facilities to tertiary facilities is currently
underway in Zambia and Zimbabwe.
This trial will address the question of
whether early application of the NASG
at the satellite health facility level
before transport to a referral hospital
will decrease maternal mortality and
morbidity.
2
decreasing blood flow to the
uterus.
Oxytocin in
prefilled
Uniject™
injection
devices
[20-26]
Used to prevent PPH
Uniject™ injection device is
an auto-disable, “all-in-one”
injection system prefilled with
a single dose of oxytocin 10
IU.




Hydrostatic
intrauterine
balloon
tamponade
Management of PPH
A hydrostatic intrauterine
balloon tamponade is a
‘balloon’ usually made of



The injection ready format
reduces wastage, simplifies
logistics.
Allows use both by lay health
personnel who do not normally
administer injections and in
areas with limited health
infrastructure
The time temperature indicator
ensures that even lay users are
able to easily assess if a specific
dose is still potent.
Oxytocin in Uniject TM has been
found to be well tolerated and
easy to use and has a high level
of acceptability among
providers.

Low cost and ready availability.
Very effective to arrest
bleeding.
Also used to test if the bleeding
is uterine or from another

Would replace the current use
of syringe and needle, which is
not very different to the
innovation.

The available evidence indicates that
the NASG substantially decreases blood
loss, but there is no evidence that its
application will reduce extreme adverse
outcomes. It is also not known if
possible side effects associated with
NASG use might outweigh potential
benefits.

No evidence that NASG contributes to
maternal mortality reduction.

The main limitation of the findings is
that none of the evidence derives from
either randomised control trials or even
a study with a control group. Such a
design cannot exclude the possibility
that secular trends or the effect of
other simultaneous interventions could
be alternative explanations of the
findings.
Furthermore, the small sample size of
studies means that chance cannot be
excluded as a likely explanation.
No evidence that Uniject™ contributes
to maternal mortality reduction.
More research is needed.



Complication rates are reported
to be low. More research is
needed to verify this.

No randomised controlled studies of
hydrostatic intrauterine balloon
tamponade have been conducted
leaving doubt on the effectiveness of
these devices. Additionally, there is no
3
[27-37]
synthetic rubber balloon
catheters that is inserted into
the uterus, at onset of a PPH.
This device is attached to a
syringe and filled with
sufficient saline solution, to
exert enough counterpressure to stop bleeding.
source


way to be certain whether a woman
who had a uterine balloon placed
would have had a different outcome
had the balloon not been placed.
Despite the many open questions,
current research does suggest that the
balloon tamponade is effective and
FIGO recommends that it should
become well integrated in the
treatment of PPH at all levels of the
health system.
No evidence that balloon tamponades
contribute to maternal mortality
reduction.
4
References:
1. WHO. WHO guidelines for the management of postpartum haemorrhage and retained placenta. Geneva: WHO, 2009.
2. Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr
1;367(9516):1066-74. PubMed PMID: 16581405. Epub 2006/04/04. eng.
3. UN. Millennium Development Goals 2012. Available from: http://www.un.org/millenniumgoals/.
4. WHO. WHO recommendations on prevention and treatment of postpartum haemorrhage: Highlights and Key Messages from New 2012
Global Recommendations. Geneva: WHO, 2012. http://www.mchip.net/sites/default/files/PPH%20Briefer%20(General).pdf.
5.WHO, UNFPA, UNICEF and AMDD. A handbook on monitoring emergency obstetric care. Geneva: WHO, 2009
http://whqlibdoc.who.int/publications/2009/9789241547734_eng.pdf
6. WHO. WHO recommendations for the prevention and treatment of postpartum haemorrhage. WHO: Geneva, 2012.
http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/9789241548502/en/index.html
7. Lester F, Stenson A, Meyer C, Morris J, Vargas J, Miller S. Impact of the Non-pneumatic Antishock Garment on pelvic blood flow in healthy
postpartum women. American journal of obstetrics and gynecology. 2011 May;204(5):409 e1-5. PubMed PMID: 21439543.
8. Kausar F, Morris JL, Fathalla M, Ojengbede O, Fabamwo A, Mourad-Youssif M, et al. Nurses in low resource settings save mothers' lives with
non-pneumatic anti-shock garment. MCN The American journal of maternal child nursing. 2012 Sep;37(5):308-16. PubMed PMID: 22895203.
9. Miller S, Turan JM, Dau K, Fathalla M, Mourad M, Sutherland T, et al. Use of the non-pneumatic anti-shock garment (NASG) to reduce blood
loss and time to recovery from shock for women with obstetric haemorrhage in Egypt. Global public health. 2007;2(2):110-24. PubMed PMID:
19280394.
10. Hensleigh PA. Anti-shock garment provides resuscitation and haemostasis for obstetric haemorrhage. BJOG : an international journal of
obstetrics and gynaecology. 2002 Dec;109(12):1377-84. PubMed PMID: 12504974.
11. Brees C, Hensleigh PA, Miller S, Pelligra R. A non-inflatable anti-shock garment for obstetric hemorrhage. International journal of
gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2004 Nov;87(2):119-24. PubMed
PMID: 15491555.
12. Miller S, Hamza S, Bray EH, Lester F, Nada K, Gibson R, et al. First aid for obstetric haemorrhage: the pilot study of the non-pneumatic antishock garment in Egypt. BJOG : an international journal of obstetrics and gynaecology. 2006 Apr;113(4):424-9. PubMed PMID: 16553654.
13. Miller S, Ojengbede O, Turan JM, Morhason-Bello IO, Martin HB, Nsima D. A comparative study of the non-pneumatic anti-shock garment
for the treatment of obstetric hemorrhage in Nigeria. International journal of gynaecology and obstetrics: the official organ of the International
Federation of Gynaecology and Obstetrics. 2009 Nov;107(2):121-5. PubMed PMID: 19628207.
5
14. Mourad-Youssif M, Ojengbede OA, Meyer CD, Fathalla M, Morhason-Bello IO, Galadanci H, et al. Can the Non-pneumatic Anti-Shock
Garment (NASG) reduce adverse maternal outcomes from postpartum hemorrhage? Evidence from Egypt and Nigeria. Reproductive health.
2010;7:24. PubMed PMID: 20809942. Pubmed Central PMCID: 2942803.
15. Ojengbede OA, Morhason-Bello IO, Galadanci H, Meyer C, Nsima D, Camlin C, et al. Assessing the role of the non-pneumatic anti-shock
garment in reducing mortality from postpartum hemorrhage in Nigeria. Gynecologic and obstetric investigation. 2011;71(1):66-72. PubMed
PMID: 21160197.
16. Miller S, Fathalla MM, Youssif MM, Turan J, Camlin C, Al-Hussaini TK, et al. A comparative study of the non-pneumatic anti-shock garment
for the treatment of obstetric hemorrhage in Egypt. International journal of gynaecology and obstetrics: the official organ of the International
Federation of Gynaecology and Obstetrics. 2010 Apr;109(1):20-4. PubMed PMID: 20096836.
17. Turan J, Ojengbede O, Fathalla M, Mourad-Youssif M, Morhason-Bello IO, Nsima D, et al. Positive effects of the non-pneumatic anti-shock
garment on delays in accessing care for postpartum and postabortion hemorrhage in Egypt and Nigeria. Journal of women's health. 2011
Jan;20(1):91-8. PubMed PMID: 21190486. Pubmed Central PMCID: 3052289.
18. Miller S. Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe (NASG) 2012. Available from:
http://clinicaltrials.gov/ct2/show/NCT00488462.
19. RTI International. Anti-shock garments to reverse hypovolemic shock and reduce obstetric hemorrhage 2011. Available from:
www.mnhtech.org/uploads/Anti-Shock-Garments.pdf
20. PATH. Resources for oxytocin in the Uniject™ injection system 2012. Available from: http://www.path.org/projects/uniject-oxytocinresources.php.
21. WHO. Stability of injectable oxytocics in tropical climates. Geneva: WHO, 1993.
22. Tsu VD, Sutanto A, Vaidya K, Coffey P, Widjaya A. Oxytocin in prefilled Uniject injection devices for managing third-stage labor in Indonesia.
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2003
Oct;83(1):103-11. PubMed PMID: 14511884.
23. Strand RT, Da Silva F, Jangsten E, Bergström S. Postpartum hemorrhage: a prospective, comparative study in Angola using a new disposable
device for oxytocin administration. Acta obstetricia et gynecologica Scandinavica. 2005;84(3):260-5.
24. Tsu VD, Luu HT, Mai TT. Does a novel prefilled injection device make postpartum oxytocin easier to administer? Results from midwives in
Vietnam. Midwifery. 2009 08/;25(4):461-5.
25. Althabe F, Mazzoni A, Cafferata ML, Gibbons L, Karolinski A, Armbruster D, et al. Using Uniject to increase the use of prophylactic oxytocin
for management of the third stage of labor in Latin America. International journal of gynaecology and obstetrics: the official organ of the
International Federation of Gynaecology and Obstetrics. 2011 Aug;114(2):184-9. PubMed PMID: 21693378.
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26. Stanton C, Newton S, Mullany L, Cofie P, Agyemang C, Adiibokah E, et al. Impact on postpartum hemorrhage of prophylactic administration
of oxytocin 10IU via UnijectTM by peripheral health care providers at home births: design of a community-based cluster-randomized trial. BMC
pregnancy and childbirth. 2012;12(1):42. PubMed PMID: doi:10.1186/1471-2393-12-42.
27. FIGO. PPH Guidelines 2012. Available from: http://www.figo.org/publications/PPH_Guidelines.
28. Manaktala U, Dubey C, Takkar A, Gupta S. Condom catheter balloon in management of massive nontraumatic postpartum haemorrhage
during cesarean section. J Gynecol Surg. 2011;27:115-7.
29. Akhter S, Begum MR, Kabir Z, Rashid M, Laila TR, Zabeen F. Use of a condom to control massive postpartum hemorrhage. MedGenMed :
Medscape general medicine. 2003 Sep 11;5(3):38. PubMed PMID: 14600674.
30. Ikechebelu JI, Obi RA, Joe-Ikechebelu NN. The control of postpartum haemorrhage with intrauterine Foley catheter. Journal of obstetrics
and gynaecology : the journal of the Institute of Obstetrics and Gynaecology. 2005 Jan;25(1):70-2. PubMed PMID: 16147704.
31. Sheikh L, Zuberi NF, Riaz R, Rizvi JH. Massive primary postpartum haemorrhage: setting up standards of care. JPMA The Journal of the
Pakistan Medical Association. 2006 Jan;56(1):26-31. PubMed PMID: 16454132.
32. Bagga R, Jain V, Sharma S, Suri V. Postpartum hemorrhage in two women with impaired coagulation successfully managed with condom
catheter tamponade. Indian journal of medical sciences. 2007 Mar;61(3):157-60. PubMed PMID: 17337818.
33. Airede LR, Nnadi DC. The use of the condom-catheter for the treatment of postpartum haemorrhage - the Sokoto experience. Tropical
doctor. 2008 Apr;38(2):84-6. PubMed PMID: 18453493.
34. Nahar N, Yusuf N, Ashraf F. Role of intrauterine balloon catheter in controlling massive PPH: experience in Rajshahi Medical College
Hospital. The Orion Med J. 2009;2:682-3.
35. Thapa K, Malla B, Pandey S, Amatya S. Intrauterine condom tamponade in management of post partum haemorrhage. Journal of Nepal
Health Research Council. 2010 04/;8(1):19-22.
36. Rather SY, Qadir A, Parveen S, Jabeen F. Use of condom to control intractable PPH. JK Science. 2010;12:127-9.
37. Sheikh L, Najmi N, Khalid U, Saleem T. Evaluation of compliance and outcomes of a management protocol for massive postpartum
hemorrhage at a tertiary care hospital in Pakistan. BMC pregnancy and childbirth. 2011;11(1):28. PubMed PMID: doi:10.1186/1471-2393-1128.
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