2017（外文）昆士兰临床指南：原发性产后出血（修订版）（下）

2017+（外文）昆士兰临床指南：原发性产后出血（修订版）（下）

Queensland Health

Queensland Clinical Guideline Supplement: Primary postpartum haemorrhage

3Levels of evidence

The levels of evidence identified in the National Health and Medical Research Council (NHMRC), Levels of evidence and grades for recommendations for developers of guidelines (2009) were used to inform the summary recommendations. Levels of evidence are outlined in Table 4. Summary recommendations are outlined in Table 5.

Note that the ‘consensus’ definition in Table 4 is different from that proposed by the NHMRC and instead relates to forms of evidence not identified in the NHMRC’s level of evidence and/or the clinical experience of the guideline’s clinical lead and working party.

Table 4. Levels of evidence

	Levels of evidence
I	Evidence obtained from a systematic review of all relevant randomised controlled
	trials.
II	Evidence obtained from at least one properly designed randomised controlled trial.
III-1	Evidence obtained from well-designed pseudo randomised controlled trials
	(alternate allocation or some other method).
III-2	Evidence obtained from comparative studies including systematic review of such
	studies with concurrent controls and allocation not randomised (cohort studies),
	case control studies or interrupted time series with a control group.
III-3	Evidence obtained from comparative studies with historical control, two or more
	single arm studies, or interrupted time series without parallel control group.
IV	Evidence obtained from case series, either post-test or pre-test and post-test.
Consensus	Opinions based on respected authorities, descriptive studies or reports of expert
	committees or clinical experience of the working party.

3.1Summary recommendations

Summary recommendations and levels of evidence are outlined in Table 5.

Table 5. Summary recommendations

	Recommendation			Grading of evidence
	1	Health care facilities should adopt a formal protocol [that is		Consensus
		established standards and systems] for the management of PPH.2
		Familiarise staff with guidelines for the management of postpartum
	2	haemorrhage and regularly practice multidisciplinary drills to reduce		IV
		the incidence of massive postpartum haemorrhage and maternal
		morbidity.3
		If placenta accreta or percreta is diagnosed antenatally:
		   Ensure consultant led multidisciplinary planning for birth
	3		o  Consultant obstetric and anaesthetic staff should be present	Consensus
			o  Confirm prompt availability of blood, fresh frozen plasma
			and platelets
			o  Choose the timing and location for birth to facilitate
			consultant presence and access to intensive care4
		If a woman has risk factors for PPH:
	4		Highlight in documentation	Consensus
			Ensure a care plan covering the third stage of labour is made and
			discussed with the woman5
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Queensland Clinical Guideline Supplement: Primary postpartum haemorrhage

	Recommendation			Grading of evidence
		Discuss and provide women with information on the benefits and
		harms of active management of third stage to support informed choice
	5	(e.g. reduced blood loss at the time of birth and concomitant		I
		treatments required, but also associated with increased hypertension,
		pain and discomfort and increased return to hospital due to postnatal
		bleeding following discharge to the community). 6
	6	[Prophylactic] Oxytocin is associated with fewer manual removals of		I
		the placenta and with the suggestion of less raised blood pressure
		than are Ergot alkaloids.7
	7	For women without risk factors for PPH, Oxytocin (10 IU by		Consensus
		intramuscular injection) is the agent of choice for prophylaxis in active
		third stage management.4
		For women who refuse blood products8 :
	8	   Optimise haemoglobin before birth to prevent avoidable anaemia.		Consensus
		   At an early stage, consider pharmacological, mechanical and
			surgical procedures to avert the use of banked blood and blood
			components
		Immediate treatment for postpartum haemorrhage should include6 :
		   Calling for appropriate help
	9		Uterine massage	Consensus
			Intravenous fluids
			Uterotonics
	10	Intravenous fluid replacement with isotonic crystalloids should be used		Consensus
		in preference to colloids for resuscitation of women with PPH.2
		During resuscitation, until bleeding is controlled9 :
			Avoid hypothermia
	11		Institute active warming	Consensus
		   Avoid excessive crystalloid use
		   Tolerate permissive hypotension (BP 80-100 mmHg systolic) until
			active bleeding controlled
		   Do not use haemoglobin alone as a transfusion trigger
	12	There is insufficient evidence to show that the addition of Misoprostol		I
		is superior to the combination of Oxytocin and Ergometrine alone for
		the treatment of PPH10 [refer to Recommendation 13].
	13	Oxytocin and Ergot alkaloid (taking into account contraindications) are		Consensus
		the first line drugs of choice in PPH. However consider the use of
		Misoprostol early.
	14	A low-dose Oxytocin infusion may be a safer alternative to a bolus		Consensus
		dose of Oxytocin in some women, such as those with major
		cardiovascular disorders.11
		If the placenta is not expelled spontaneously, offer 10 IU of Oxytocin
		in combination with controlled cord traction2 :
	15	   Ergometrine is not recommended, as it may cause tetanic uterine		Consensus
			contractions, which may delay expulsion of the placenta2
		   Do not use intravenous infusion of Oxytocin to assist the birth of
			the placenta5
	16	For management of intractable bleeding, consider medical procedures		Consensus
		such as intrauterine balloon tamponade and selective angiographic
		embolisation.2,4,12
		For the treatment of PPH due to uterine atony after vaginal birth2 :
	17	   Bimanual uterine compression may be offered as a temporary		Consensus
			measure
		   Uterine packing is not recommended
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Queensland Clinical Guideline Supplement: Primary postpartum haemorrhage

Recommendation								Grading of evidence
18	For the management of intractable bleeding unresponsive to medical							Consensus
	treatment, consider surgical procedures such as uterine artery ligation,
	B-Lynch compression suture and hysterectomy.4,12
19	The decision to use Tranexamic Acid should rest with the Medical							Consensus
	specialist prescribing and practice review is advised.
	Consider Tranexamic Acid when first and second line drugs are
20	ineffective in controlling PPH11 or when bleeding is thought to be due							I
	to trauma.
21	The routine use of rFVIIa is not recommended due to its lack of effect							Consensus
	on mortality and variable effect on morbidity.9
22	In the event of intractable obstetric haemorrhage, the administration of							Consensus
	rFVIIa may be an option to be discussed with the haematologists.4
	Institutions may choose to develop a process for the use of rFVIIa
	where there is9 :
	   Uncontrolled haemorrhage in salvageable patients, and
23	   Failed surgical or radiological measures to control bleeding, and							Consensus
	   Adequate blood component replacement, and
	   pH > 7.2, temperature > 340C9
	Discuss dose with haematologist/transfusion specialist.
	NB. rFVIIa is not licensed for use in this situation; all use must be part
	of practice review.9
24	In patients with critical bleeding requiring massive transfusion, the use							Consensus
	of an MTP to facilitate timely and appropriate use of RBC and other
	blood components may reduce the risk of mortality.9
	In patients with critical bleeding requiring activation of the massive
25	transfusion protocol, insufficient evidence was identified to support or							Consensus
	refute the use of specific ratios of RBCs to blood components.9
	However consider RBC:blood components ratios of 1:1.
	Independent of other laboratory indicators, a fibrinogen level between
26	2 and 3 g/L, usually considered normal in a non-pregnant woman, is							Consensus
	also associated with a nearly doubled risk of severe haemorrhage and
	may constitute an early warning sign.13
27	Consider offering pharmacological VTE prophylaxis to postnatal							Consensus
	women who have had excess blood loss or blood transfusion. 14
28	If the Hb is less than 7-8 g/dL in the postnatal period and where there							Consensus
	is no continuing or threat of bleeding, the decision to transfuse should
	be made on an informed individual basis.8
	Provide debriefing by a senior team member at the earliest opportunity
29	after the event4 and prior to discharge:							Consensus
	   Organise follow up as needed
	In elective caesarean section consider administration of Carbetocin
30	instead of an Oxytocin infusion 15 [refer to an Australian pharmacopeia							Level I
	and Queensland Health List of Approved Medicines (LAM) for
	complete drug information].

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Queensland Clinical Guideline Supplement: Primary postpartum haemorrhage

4Implementation

This guideline is applicable to all Queensland public and private maternity facilities. It can be downloaded in Portable Document Format (PDF) from www.health./qcg

4.1Guideline resources

The following guideline components are provided on the website as separate resources:

· Flow chart: PPH initial response

· Flow chart: PPH massive transfusion protocol

· Flow chart: PPH emergency donor panel activation

4.2Suggested resources

During the development process stakeholders identified additional resources with potential to complement and enhance guideline implementation and application. The following resources have not been sourced or developed by Queensland Clinical Guidelines but are suggested as complimentary to the guideline:

· Queensland Government: Blood and blood products transfusion consent

· Queensland Government: Blood and blood products transfusion consent – consent information – patient copy

· Queensland Health: Guideline for the storage, transportation and handling of refrigerated medicines, vaccines, and blood in Queensland Health facilities

· Queensland Government: Procedure for receiving and returning blood/blood products at remote sites and monitoring remote blood fridges

· Queensland Blood Management Program: Management framework for emergency donor panels

· Australian Red Cross Blood Service

· Australian and New Zealand Society of Blood Transfusion Guidelines

· South Australian Perinatal Practice Guidelines: Chapter 89 Balloon tamponade and uterine packing for major PPH

4.3Implementation measures

Suggested activities to assist implementation of the guideline are outlined below.

4.3.1Queensland Clinical Guidelines measures

· Notify Chief Executive Officer and relevant stakeholders

· Monitor emerging new evidence to ensure guideline reflects contemporaneous practice

· Capture user feedback

· Record and manage change requests

· Review guideline in 2017

4.3.2Hospital and Health Service measures

· Table the guideline at the local Patient Safety and Quality Committee meeting

· Replace all other guidelines on this topic with the current version of this guideline

· Promote the introduction of the guideline to relevant health care professionals (e.g. at staff forums, clinical handovers, incorporate into orientation packages)

· Provide PPH initial response and treatment education and practice training by:

%1 Conducting multidisciplinary practice drills for PPH

%1 Facilitating clinician attendance at the Queensland Clinical Guidelines video-conference on PPH

%2 Inclusion into inservice or professional development training

· Develop or access suggested resources as identified in Section 4.2

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Queensland Clinical Guideline Supplement: Primary postpartum haemorrhage

4.4Clinical quality measures

The following clinical quality measures are suggested:

· Audit total number of women who birth vaginally and receive a blood transfusion during the same admission

· Audit total number of women who undergo caesarean section and receive a blood transfusion during the same admission

· Audit all cases where women have had a blood loss greater than 1000 mL. Review:

%1 Management of labour

%1 Management of PPH, especially with the timing of events

%2 In major PPH: Appropriate and effective communication chain with timely provision of blood products

· Audit proportion of PPH cases with blood loss greater than 1000 mL that reported to the risk management team

· Audit proportion of clinicians who have participated in multidisciplinary practice drills for

PPH

· Audit proportion of relevant staff (e.g. clinicians, laboratory staff, wards persons) who are familiar with their role in the local massive transfusion protocol

· Audit the appropriate use of blood products in the management of PPH (e.g. RBC)

· Audit documentation of women with placenta accreta to determine proportion who had:

%2 The diagnosis anticipated

%1 Adequate antenatal work-up (e.g. avoiding/treating anaemia) o Antenatal imaging performed

o  Care appropriate for the clinical situation, that is:

· Consultant obstetrician planned and directly supervising delivery

· Consultant anaesthetist planned and directly supervising anaesthetic at delivery

· Blood and blood products available

· Multidisciplinary involvement in preoperative planning

· Discussion and consent includes possible interventions (such as hysterectomy, leaving the placenta in place, cell salvage and interventional radiology)

· Anticipated the need for a critical care bed

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Queensland Clinical Guideline Supplement: Primary postpartum haemorrhage

5References

1. Belfort MA, GA DI. Postpartum hemorrhage and other problems of third stage. In: High risk pregnancy: management options. 4th ed. St Louis: Elsevier Saunders; 2011.

2. World Health Organisation. WHO guidelines for the management of postpartum haemorrhage and retained placenta. 2009.

3. Rizvi F, Mackey R, Barret T, McKenna P, Geary M. Successful reduction of massive postpartum haemorrhage by use of guidelines and staff education. British Journal of Obstetrics and Gynaecology: an International Journal of Obstetrics and Gynaecology. 2004; 111:495-8.

4. Royal College of Obstetricians and Gynaecologists. Prevention and management of postpartum haemorrhage. Green-top Guideline No.52. 2009.

5. National Institute for Health and Clinical Excellence. Intrapartum care: care of healthy women and their babies during childbirth. CG55. London: National Institute for Health and Clinical Excellence. 2007.

6. Begley CM, Gyte GML, Devane D, McGuire W, Weeks A. Active versus expectant management for women in the third stage of labour. Cochrane Database of Systematic Reviews 2011, Issue 11. Art. No.: CD007412. DOI: 10.1002/14651858.CD007412.pub3.

7. National Institute for Health and Clinical Excellence. Venous thromboembolism: reducing the risk. CG92. London: National Institute for Health and Clinical Excellence; 2010.

8. Royal College of Obstetricians and Gynaecologists. Blood transfusion in obstetrics. Green-top Guideline No.47. 2007 [Minor revisions 2008 July].

9. National Blood Authority Australia. Patient blood management guidelines: module 1 - critical bleeding/massive transfusion. Australian Government. 2011.

10. Moussa HA, Alfirevic Z. Treatment of primary postpartum haemorrhage. Cochrane Database of Systematic Reviews 2007, Issue 1 Art. No.: CD003249. DOI: 10.1002/14651858.CD003249.pub2.

11. Novikova N, Hofmeyr GJ. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database of Systematic Reviews 2010, Issue 7. Art. No.: CD007872. DOI: 10.1002/14651858.CD007872.pub2.

12. Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG). Management of postpartum haemorrhage (C-Obs 43). 2011 [cited 2012 May 15]. Available from: http://www. .

13. Cortet M, Deneux-Tharaux C, Colin C, Rodigoz R-C, Bouvier-Colle M-H, Hussoud C. Association between fibrinogen level and severity of postpartum haemorrhage: secondary analysis of a prospective trial. British Journal of Anaesthesia. 2012; 108(6):984-989.

14. Queensland Maternity and Neonatal Clinical Guidelines Program. Venous thromboembolism (VTE) prophylaxis in pregnancy and the pueperium. Guideline No. MN09.9-V3-R14. Queensland Health. 2009.

15. Su L, Chong Y, Samuel M. Carbetocin for preventing postpartum haemorrhage. Cochrane Database of Systematic Reviews. 2012; Issue 4. Art. No.:CD005457. DOI: 10.1002/14651858.CD005457.pub4.

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