Title: WHO Recommendations for the Prevention of Postpartum Haemorrhage Results from a WHO Technical Consultation
1WHO Recommendations for the Prevention of
Postpartum HaemorrhageResults from a WHO
Technical Consultation October 18-20,
2006Panel Presentation M E Stanton, USAID R
Derman, UM/KC H Sangvhi, JHPIEGO D Armbruster,
POPPHI/PATH
2Background
- While there is general agreement on the
beneficial effects of AMTSL, there are several
unresolved issues - Clear definitions of components
- AMTSL under conditions of limited resources
- Timing of uterotonic
- Drug to use
- Route of administration
- Can non-skilled providers use controlled cord
traction?
3Background
- Is early clamping of cord necessary?
- What does early mean?
- Suggestions to provide misoprostol where oxytocin
not available to non-skilled providers and women
themselves - Concerns that misuse of misoprostol can lead to
significant maternal morbidity and even death
4Rationale for WHO Technical Consultation
- In light of these issues, WHO held a Technical
Consultation on PPH in Geneva on 18-20 October
2006 to - Discuss various issues related to prevention of
PPH - Develop recommendations
5Methods
- Questions drafted by WHO staff (MPS, RH,
Medicines, Policies and Standards) on various
intervention described for prevention of atonic
PPH (AMTSL and its components) - Each question was subdivided to address skilled
or non-skilled provider - These questions and proposed outcomes to consider
were sent to international panel of experts (58
experts in 6 WHO regions 37 responses received)
6Methods
- Helped define critical outcomes vs. important
but not critical - Responses were reviewed by WHO core team
- External organization commissioned to review and
grade the evidence to answer the questions, using
the GRADE methodology
7Methods
- Evidence-based recommendations in response to the
questions asked were drafted - Draft methodology, results, and recommendations
were sent to sub-group of experts prior to their
participation in the WHO Technical Consultation
on PPH - This draft and supporting evidence were reviewed
at the Technical Consultation and changes made
based on the recommendations of the expert panel.
8Grades of Recommendation Assessment, Development
and Evaluation
- Assess the quality of evidence, prepare evidence
profiles - Choose questions and rate importance of outcomes
for decision making (before considering the
evidence) - Assess the overall risk-benefit ratio,
considering cost, access, and feasibility
9Categories of quality
- High Further research is very unlikely to change
our confidence in the estimate of effect. - Moderate Further research is likely to have an
important impact on our confidence in the
estimate of effect and may change the estimate.
- Low Further research is very likely to have an
important impact on our confidence in the
estimate of effect and is likely to change the
estimate. - Very low Any estimate of effect is very
uncertain.
10Judgements about the balance between benefits and
harms
- Strong recommendation the panel is confident
that the desirable effects of adherence to a
recommendation outweigh the undesirable effects. - Weak recommendation the panel concludes that the
desirable effects of adherence to a
recommendation probably outweigh the undesirable
effects, but is not confident.
11Critical beneficial outcomes
- What are the most important beneficial or
priority outcomes of interventions to prevent
PPH? - Reduction in maternal mortality
- Less blood loss gt 1000 ml
- Less use of blood transfusion
- Less use of uterotonics (added by the expert
panel)
Fewer maternal deaths 8.5
Fewer admissions to intensive care unit 6.4
Less blood loss gt 500 mL 6.3
Less blood loss gt 1000 mL 7.7
Less need for blood transfusion 7.8
Less need for additional uterotonics 5.9
Decreased mean blood loss 5.6
Less postpartum anaemia 6.1
Earlier establishmend of breast feeding 5.1
Less anaemia in infancy 4.8
12Evidence and Recommendations
131. Should AMTSL be offered by skilled attendants
to all women
- Recommendation
- AMTSL should be offered by skilled attendants to
all women - Recommendation STRONG
- Quality of evidence MODERATE
- The panel does not recommend AMTSL by non-skilled
attendants - Remarks Although no evidence was found for or
against the use of AMTSL by non-skilled
providers, the group placed high value on the
potential risks such as uterine inversion
that may result from inappropriate cord traction.
1 systematic review 5 trials UK, Ireland,
UAE Different combinations of the components
142. Should oxytocin (10 IU parenterally) or
ergometrine/methylergometrine (0.25 mg
parenterally) be offered in AMTSL?
- Recommendation
- Oxytocin 10 IU IM should be offered to all women
in preference to ergometrine - If oxytocin is not available ergo/methylergo or
syntometrine should be offered to women without
hypertension and heart disease - Recommendation STRONG
- Quality of evidence LOW
- Remarks The recommendation places a high value
on avoiding the adverse effects of ergometrine,
and assumes similar benefit for oxytocin and
ergometrine.
2 systematic reviews gt 9,000 women Oxytocin vs.
ergometrine vs. syntometrine Oxytocin dose (2-10
IU), IM/IV Only one trial with direct comparison
(1049 women)
153. Should oral misoprostol (600 mcg) be offered
instead of oxytocin (10 IU IM) in AMTSL?
- Recommendation
- In the context of AMTSL skilled attendants should
offer oxytocin in preference to oral misoprostol
(600 mcg). - Recommendation STRONG
- Quality of evidence HIGH
- Remarks This recommendation places a high value
on the relative benefits of oxytocin in
preventing blood loss compared to misoprostol, as
well as the increased adverse effects of
misoprostol compared to oxytocin
One systematic review 7 trials with direct
comparison Largest trial gt 18,000 women
164. Should sublingual misoprostol (600 mcg) be
offered instead of oxytocin (10 IU IM)?
- Recommendation
- In the context of AMTSL skilled attendants should
not offer sublingual misoprostol for prevention
of PPH in preference to oxytocin - Recommendation STRONG
- Quality of evidence VERY LOW
- Remarks Further research is needed to define the
role of sublingual misoprostol administration for
prevention of PPH
One systematic review 2 trials lt 200 women 1
trial compared to syntometrine
175. Should rectal misoprostol (600 mcg) be
offered instead of oxytocin (10 IU IM)?
- Recommendation
- In the context of AMTSL skilled attendants should
not offer rectal misoprostol for prevention of
PPH in preference to oxytocin - Recommendation STRONG
- Quality of evidence LOW
- Remarks This recommendation places a high value
on the known benefits of oxytocin and notes the
significant uncertainty about whether rectal
misoprostol is equivalent. Misoprostol has more
adverse effects and a higher purchase cost.
Two systematic reviews Two oxytocin trials (one
with 5 IU the other 10IU, 1221 women in
total) One misoprostol trial (1620 women,
auxiliary nurse-midwives)
186. Should carboprost 0.25 mg/sulprostone 0.5 mg)
be offered instead of oxytocin (10 IU IM)?
- Recommendation
- In the context of AMTSL skilled attendants should
not offer carboprost/sulprostone in preference of
oxytocin - Recommendation STRONG
- Quality of evidence VERY LOW
- Remarks This recommendation is based on the
paucity of evidence comparing the two treatments
and the known effectiveness of oxytocin.
One systematic review Eight trials comparing
injectable prostaglandins with other injectable
uterotonics No study has compared
carboprost/sulprostone with 10 IU oxytocin IM
197. In the absence of AMTSL, should uterotonics
be used alone for prevention of PPH?
- Recommendation
- In the absence of AMTSL, a uterotonic drug
(oxytocin or misoprostol) should be offered by a
health worker trained in its use for prevention
of PPH - Recommendation STRONG
- Quality of evidence MODERATE
- Remarks For misoprostol, this recommendation
places a high value on the potential benefits of
avoiding PPH and ease of administration of an
oral drug in settings where other care is not
available, but notes there is only one study. - The only trial relevant to this recommendation
used 600 mcg of misoprostol. The efficacy of
lower doses has not been evaluated. There is
still uncertainty about the lowest effective dose
and optimal route of administration.
Two systematic reviews Two oxytocin trials (one
with 5 IU the other 10IU, 1221 women in
total) One misoprostol trial (1620 women,
auxiliary nurse-midwives)
208. When should the cord be clamped to maximize
benefits for mother and baby?
- Recommendation
- Because of the benefits to the baby, the cord
should not be clamped earlier than necessary for
applying cord traction in AMTSL. - Recommendation WEAK
- Quality of Evidence LOW
- For the sake of clarity, it is estimated that
this will normally take around 3 minutes - Early clamping may be required if the baby is
asphyxiated and requires immediate resuscitation.
One systematic review three additional
trials varying definitions of early clamping (10
sec 1 min) and delayed (2 min stopping
pulsation) no priority outcomes reported, but
newborn anemia as an important outcome unclear
whether timing of cord clamping has an effect on
PPH
219. Should the placenta be delivered by
controlled traction in all women?
- Recommendation
- Given the current evidence for AMTSL includes
cord traction, the panel does not recommend any
change in the current practice. Further research
is needed. - Recommendation STRONG
- Quality of evidence VERY LOW
22Key discussion points
- Who is a skilled attendant?
- Discussed extensively in context of components of
AMTSL - Combines WHO, FIGO, ICM definition of 2004 with
earlier definition by WHO, UNFPA, UNICEF and
World Bank - Older definition is broader and considers
variable conditions on many low and middle-income
developing countries - Can include auxiliary nurse-midwives, community
midwives, village midwives and health visitors
who have acquired appropriate skills, if
specially trained
23Key discussion points
- Implementation of recommendations
- Support from international professional
organizations and partner agencies for changes in
policy and regulation - Work through regional and country offices (WHO
and partners) - Press release and co-publication
- Misoprostol in EDL for PPH indications
- Translation of recommendations
- Disseminaton and implementation of
recommendations - Develop a feedback mechanism
- Develop a virtual PPH network
24Research Priorities
- Not in priority order
- What dose and route of administration of
misoprostol are preferred for best risk-benefit
ratio (in AMTSL and expectant management) - Can oxytocin be administered safely by unskilled
attendants? - What is role of buccal and sublingual use of
oxytocin? - What is the effect of uterotonics on breastfeeding
25Research Priorities
- With AMTSL, should misoprostol be used in
addition to oxytocin - What is the optimal time for cord clamping in the
context of physiologic management and AMTSL? - What is the optimum time for oxytocin
administration in AMTSL to optimize the timing of
cord clamping? - What is the role of individual components of
AMTSL?
26Additional Research priorities
- Individual components of AMTSL
- Oxytocin (Uniject) vs. misoprostol where AMTSL is
not (or will not) be practiced - Use of a validated blood measurement drape
27Implications
- Preventing PPH where skilled provider present
- AMTSL, Oxytocin preferable
- Use Ergometrine or Methylergometrine only if
oxytocin not available. However, no similar
guidance on use of misoprostol as an alternative
if others are not available - Oral, sublingual, or rectal misoprostol or
carboprost should not be used instead of
oxytocin. - From practical and logistics perspectives
- Programs should promote AMTSL universally with
Oxytocin - FIGI-ICM guidelines are fully supported.
28Implications
- Births not attended by skilled providers
- WHO strongly recommends use of oxytocin or
misoprostol provided by trained health workers
even when all components of AMTSL cannot be
provided - Any trained health worker (not skilled attendant)
who is present may provide Oxytocin or
misoprostol after birth of baby. - By implication, WHO strongly recommends the
provision of misoprostol by trained health
workers (eg community health volunteers) to
pregnant women for use after childbirth - WHO is pursuing inclusion of prevention of pph as
an indication for misoprostol in the WHO
essential medicines list.
29Implications
- The panel made a weak recommendation on delayed
clamping of cord - In practical terms following childbirth, give
oxytocin, proceed to dry and warm baby, await
uterine contraction (which will usually occur in
2-3 minutes), clamp and cut cord, perform CCT,
deliver placenta, and perform uterine massage - Cord should not be clamped immediately but after
uterine contraction occurs, in indication that
CCT should then begin
30Next Steps
- Paradigm Shift is occurring with new activities
and programs available to save lives - PPH prevention strategies are expanding to
include home/community as well as facilities - AMTSL is becoming available to a broader group of
health workers provided they are trained to
competency in the skills. - Misoprostol is accepted as a strategy for PPH
prevention - Oxytocin will be more accessible to communities
with Uniject and with the temperature monitor
(VVM)
31Program Implications and Next Steps
- Discussion Panel and Audience
- Thank you