Transcript WHO recommendations on PPH prevention

WHO Recommendations for
the Prevention of Postpartum
Haemorrhage
Results from a WHO Technical
Consultation – October 18-20, 2006
Deborah Armbruster, POPPHI/PATH
White Ribbon Alliance/ Core Group/ POPPHI
September 25, 2007
Summary of Recommendations
• Active management of the third stage of labor should
be offered by skilled attendants to all women.
• In the context of AMTSL: Skilled attendants should
offer oxytocin in preference to ergometrine,
methylergometrine, Syntometrine, misoprostol,
Carboprost.
• 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.
• Because of the benefits to the baby, the cord should
not be clamped earlier than is necessary for applying
controlled cord traction in AMTSL.
• For the sake of clarity, it is estimated that this will normally take
around 3 minutes
Background
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?
Background
• 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
Rationale 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
Methods
• 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)
Methods
• 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
Methods
• 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.
Grades of Recommendation Assessment,
Development and Evaluation
1. Assess the quality of evidence, prepare
evidence profiles
2. Choose questions and rate importance of
outcomes for decision making (before
considering the evidence)
3. Assess the overall risk-benefit ratio,
considering cost, access, and feasibility
Categories 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. +
Judgements 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.
Critical beneficial outcomes
Fewer maternal deaths
8.5
Fewer admissions to intensive care
unit
6.4
Less blood loss > 500 mL
6.3
Less blood loss > 1000 mL
7.7
Less need for blood transfusion
7.8
What are the most important
beneficial or “priority”
outcomes of interventions to
prevent PPH?
• Reduction in maternal
mortality
• Less blood loss > 1000 ml
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
• Less use of blood
transfusion
• Less use of uterotonics
(added by the expert panel)
Evidence and Recommendations
1. Should AMTSL be offered by skilled
attendants to all women
1 systematic review
5 trials
UK, Ireland, UAE
Different combinations of the components
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.
2. Should oxytocin (10 IU parenterally) or
ergometrine/methylergometrine (0.25 mg
parenterally) be offered in AMTSL?
2 systematic reviews
> 9,000 women
Oxytocin vs. ergometrine vs. syntometrine
Oxytocin dose (2-10 IU), IM/IV
Only one trial with direct comparison (1049 women)
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.
3. Should oral misoprostol (600 mcg) be offered
instead of oxytocin (10 IU IM) in AMTSL?
One systematic review
7 trials with direct comparison
Largest trial > 18,000 women
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
4. Should sublingual misoprostol (600 mcg) be
offered instead of oxytocin (10 IU IM)?
One systematic review
2 trials
< 200 women
1 trial compared to syntometrine
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
5. Should rectal misoprostol (600 mcg) be
offered instead of oxytocin (10 IU IM)?
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)
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.
6. Should carboprost 0.25 mg/sulprostone 0.5
mg) be offered instead of oxytocin (10 IU IM)?
One systematic review
Eight trials comparing injectable prostaglandins with other injectable uterotonics
No study has compared carboprost/sulprostone with 10 IU oxytocin 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.
7. In the absence of AMTSL, should uterotonics
be used alone for prevention of PPH?
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)
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.
8. When should the cord be clamped to
maximize benefits for mother and baby?
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
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.
9. 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
Key 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 nursemidwives, community midwives,
village midwives and health visitors
who have acquired appropriate
skills, if specially trained
Key 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”
Research Priorities
Not in priority order
• What dose and route of
administration of misoprostol
are preferred for best riskbenefit 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
Research 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?
Summary of Recommendations
• Active management of the third stage of labor should be offered
by skilled attendants to all women.
• In the context of AMTSL: Skilled attendants should offer oxytocin
in preference to ergometrine, methylergometrine, Syntometrine,
misoprostol, Carboprost.
• 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.
• Because of the benefits to the baby, the cord should not be
clamped earlier than is necessary for applying controlled cord
traction in AMTSL.
•
For the sake of clarity, it is estimated that this will normally take around 3
minutes
Program Implications and Next Steps
For you to define… but could be:
• Educate policy-makers about the need to adopt and
operationalize these new guidelines
• Increase resources to fund AMTSL training or ensure
that sufficient oxytocin is available for every women
at birth.
• Get misoprostol registered in-country and create
protocols for its use
• Document successes and communicate to the media
and decision-makers