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MATERNAL AND NEWBORN CARE

Postpartum hemorrhage today: ICM/FIGOinitiative 2004—2006

A. Lalonde a,*, B.A. Daviss b,1, A. Acosta c,2, K. Herschderfer d,3

a FIGO Safe Motherhood and Newborn Health, The Society of Obstetricians and Gynaecologists of Canada(SOGC), Ottawa, ON, Canadab FIGO Safe Motherhood and Newborn Health, FIGO/ICM Postpartum Hemorrhage Initiative, Canadac International Federation of Gynecology and Obstetrics (FIGO), London, UKd International Confederation of Midwives (ICM), The Hague, The Netherlands

0020-7292/$ - see front matter D 200All rights reserved.doi:10.1016/j.ijgo.2006.04.016

4 Corresponding author. Tel.: +1 6134314.

E-mail address: alalonde@sogc.com1 Tel./fax: +1 613 730 0282.2 Tel.: +44 20 7928 1166; fax: +44 203 Tel.: +31 70 3060530; fax: +31 70 3

KEYWORDSPostpartumhemorrhage;Active management ofthe third stage oflabor;Misoprostol;Tamponade;Anti-shock garment

Abstract Postpartum hemorrhage (PPH) is the main cause of maternal mortality.Yet, even though solutions have been identified, governments and donor countrieshave been slow to implement programs to contain the problem. While poverty andlow educational level remain the underlying cause of PPH, the current literaturesuggests that active management of the third stage of labor can prevent it. TheInternational Confederation of Midwives (ICM) and the International Federation ofGynecology and Obstetrics (FIGO) are attempting to address the chronic PPH crisis byeducating their members on best practices and on troubleshooting where resourcesare inadequate. Some studies found oxytocin to be preferable to misoprostol insettings where active management is the norm. However, secondary clinical effectsmay prove more troublesome with oxytocin than with misoprostol, and misoprostolmay prove to be more practical and equally effective in low-resource settings. Twonew interventions are also proposed, the anti-shock garment and the balloontamponade.D 2006 International Federation of Gynecology and Obstetrics. Published byElsevier Ireland Ltd. All rights reserved.

bWomen are not dying because of a disease we

cannot treat. They are dying because societieshave yet to make the decision that their lives are

6 International Federation of

730 4192; fax: +1 613 730

(A. Lalonde).

7928 7066.555651.

worth saving.Q (Mahmoud Fathalla, President ofthe International Federation of Gynecology andObstetrics (FIGO), World Congress, Copenhagen,1997)

1. Introduction

The wife of Shah Jahan of India, Empress Mumtaz,had 14 children and died of postpartum hemor-

International Journal of Gynecology and Obstetrics (2006) 94, 243—253

Gynecology and Obstetrics. Published by Elsevier Ireland Ltd.

A. Lalonde et al.244

rhage (PPH) in 1630. So great was Shah Jahan’slove for his wife that he built the world’s mostbeautiful tomb—the Taj Mahal—in her memory [1].Far away to the north, another country was takinga very different, three-tiered approach. TheSwedish Collegium Medicum was established in1663; the Swedish clergy created an informationsystem that, by 1749, provided the first nationalvital statistics registry in Europe; and by 1757,training was approved for midwives of all parishesin Sweden. The resulting infrastructure, a com-prehensive midwifery system backed by physicianexpertise and a system for reporting outcomes, isconsidered responsible for reducing maternalmortality in Sweden from 900 to 230 per100,000 live births between 1751 and 1900 [2].To this day, Sweden has one of the lowest MMRs inthe world.

In 2006, each nation must decide whether it willbuild monuments to hardship and suffering or takesteps to avoid misery. Although fully 10 yearsremain until the target date of 2015, it is alreadypredicted that the Millennium Development GoalNo. 5, to reduce the MMR (MMR) by 75%, will not bereached. Maternal mortality is currently estimatedat 529,000 deaths per year, a number that trans-lates into a global ratio of 400 maternal deaths per100,000 live births [3]. Another way to characterizethese deaths is to say that, because of childbear-ing, 1 woman dies every minute of every hour ofevery day.

Most of the deaths and disabilities attributed tochildbirth are avoidable. Indeed, 99% of maternaldeaths occur in developing countries that haveinadequate transport systems, limited access toskilled caregivers, and poor emergency obstetricalservices [4]. It is a given that each mother andnewborn require care that is close to where theylive, respectful of their culture, and provided bypersons with enough skill to act immediately shoulda complication occur. The challenge that remainsinternationally is not technological, but strategicand organizational [4].

Postpartum hemorrhage is the most commoncause of maternal mortality and accounts for one-quarter of all maternal deaths worldwide [5]. Theoptimal solution for the vast majority—if not all—deaths caused by PPH is prevention, both beforedelivery by assuring that women are sufficientlyhealthy to withstand PPH, and at the time ofdelivery with appropriate labor management. Totheir credit, the International Confederation ofMidwives (ICM) and the International Federation ofGynecology and Obstetrics (FIGO) are engagingtheir membership in a worldwide campaign toaddress the PPH tragedy.

2. Definition and incidence

The World Health Organization (WHO) has exam-ined studies on PPH published between 1997 and2002 to arrive at more precise definitions of PPHand estimates of its incidence [6]. Availableresources, however (data from 50 countries, 116studies, and 155 unique data sets) were notadequate. Definitions of PPH were lacking in 58%of the published studies, and in the population-based surveys, the rates ranged from 0.55% ofdeliveries in Qatar to 17.5% in Honduras. Prelimi-nary findings suggest that excessive bleeding wasreported to have occurred in 0.84% to 19.80% ofdeliveries, but most studies shunned the issues ofdefining and diagnosing PPH.

One of the major problems is how to measureblood loss with accuracy. Published data are scant,and a gold-standard method is lacking. Clinicalvisual estimation of blood loss is not reliable [7],and as is often the case, necessity becomes themother of invention. In the rural areas of Tanza-nia, the use of bkangasQ has been adopted as avalid instrument [8]. Convenient because it isproduced and sold locally, the precut kanga is arectangle of local cotton fabric measuring100cm�155cm. When 3—4 kangas are soakedduring a delivery, the trained traditional birthattendant is entrusted to transfer the woman to ahealth center.

Even when a good measurement method is inplace, defining PPH simply as a blood loss greaterthan 500mL does not take into account theunderlying health factors responsible for the bloodloss, and since the quantity of blood lost is oftenless important than the effect it has on thewoman, it has been suggested that a usefuldefinition takes into account any blood loss thatcauses a major physiologic change (e.g., a fall inblood pressure) that threatens the woman’s life.

3. PPH: when, why, and where?

Sixty percent of all maternal deaths occur duringthe postpartum period, and one source suggeststhat 45% of these deaths occur in the first 24h afterdelivery [9].

The risk of dying from PPH depends not only onthe amount and rate of blood loss but also on thehealth of the woman [10]. Poverty, unhealthylifestyle, malnutrition, and women’s lack of controlover their reproductive health are some of thebroad issues that, unfortunately, have come to beaccepted as inevitable and unchangeable. In a busy

Postpartum hemorrhage today: ICM/FIGO initiative 2004—2006 245

urban maternity hospital, in the country where theTaj Mahal stands witness to this problem, nurses ina labor ward may not complete a patient’s casenotes because she is of a low caste and, thus,deprive her of the safeguards afforded otherwomen [3]. But India’s problems are merelysymbolic of what faces both high- and low-resourcecountries [3,4,11]. Two-thirds of the women whoincur PPH have no identifiable clinical risk factorssuch as multiple pregnancy or fibroids [12]. In thisregard, PPH is a veritable equal-opportunity occur-rence. However, it is not an equal-opportunitykiller. It is the poor, malnourished, unhealthywoman delivered away from medical care who willdie from it. On the other hand, the woman who isfortunate enough to be delivered near a well-staffed and well-supplied medical facility will mostlikely survive the three usual delays: delay inrecognizing a complication and seeking help; delayin accessing transportation to reach a medicalfacility; and delay in receiving adequate andcomprehensive care upon arrival to the medicalfacility.

About 95% of all maternal deaths in 2000 wereequally distributed between Asia (253,000) andsub-Saharan Africa (251,000) [13], but with greaterrisks in Africa because it has a smaller population.With more than 900 maternal deaths per 100,000live births, sub-Saharan Africa has for decades beenthe region with the highest MMR. In this region, thenumber births attended by skilled health personneland life expectancy at birth strongly correlate withmaternal mortality.

As an example, the increased ability to mea-sure maternal mortality in Afghanistan hasrevealed a suspected but heretofore unconfirmedreality. The retrospective cohort study of womenof reproductive age conducted in four districtsfrom four provinces by the Centers for DiseaseControl and Prevention reported an astoundingmaternal mortality of 1900 per 100,000 live births[14]. Another group of authors describes reasonsfor such a high MMR in the Afghanistan province ofHerat:

b[C]onditions for individual and community healthoften depend on the protection and promotion ofhuman rights. The findings of this study identify anumber of human rights factors that contribute topreventable maternal deaths in Herat Province.These include access to and quality of healthservices, adequate food, shelter, and clean water,and denial of individual freedoms such as freelyentering into marriage, access to birth controlmethods and possibly control over the numberand spacing of one’s children.Q [15]

In many other countries, PPH accounts for morethan half of maternal deaths, rather than for thequarter worldwide. For example, it has beenreported to be 43% in Indonesia, 53% in thePhilippines, and 53% in Guatemala [4].

Within given countries certain populations arealso at increased risk. In Latin America, forexample, the Pan American Health Organizationhas identified three main reasons for a highermaternal mortality among indigenous populations:(1) The professional teams in charge of maternitycare underrate or are ignorant of traditionalcultural practices; (2) health teams and pregnantwomen often communicate poorly, a principalfactor behind low maternal enthusiasm for mater-nity care; and (3) public policies for consensusbuilding and intercultural dialogue on maternalhealth are in conflict with established objectivesand goals and the allocation of resources [16].

4. Existing evidence for PPH prevention

In September 2004, Litch [17] provided a summaryof the evidence in favor of active management ofthe third stage of labor. The following excerptsummarizes these data:

bFrom 1988 to 1998, four large randomized con-trolled studies conducted in well-resourced mater-nity hospitals (two in the United Kingdom, one inthe United Arab Emirates and one in Ireland)compared the effects of active and expectantmanagement of the third stage of labor. In all fourstudies, active management was associated with adecrease in PPH and the length of third stage oflabor. . .A Cochrane Library systematic review andmeta-analysis also concluded that active manage-ment of the third stage in the setting of a maternityhospital was superior to expectant management inreducing blood loss, incidence of postpartumhemorrhage and duration of the third stage; itwas also associated with reduced postpartumanemia, decreased need for blood transfusion,and less use of additional therapeutic uterotonicdrugs.Q [17]

To a certain extent, the same caveat holds forthe use of prostaglandins, since at least twoCochrane reviews have addressed the issue ofmisoprostol, a prostaglandin E1 analogue, as achoice for use in the prevention and treatment ofPPH. A 2003 review suggests that 800Ag of miso-prostol administered rectally may be a bfirst-lineQdrug for the treatment of primary PPH, but thatfurther randomized controlled trials are required to

A. Lalonde et al.246

identify the best drug combinations, route, anddose for the treatment of PPH; and a 2004 reviewreports that b[n]either intramuscular prostaglan-dins nor misoprostol are preferable to conventionalinjectable uterotonics as part of the active man-agement of the third stage of labor, especially forlow-risk women. Future research on prostaglandinused after birth should focus on the treatment ofpostpartum hemorrhage rather than preventionwhere they seem to be more promisingQ [18].

Even a WHO multicenter randomized trial leftsome issues unresolved. It concluded that 10 IU ofoxytocin (intravenous or intramuscular) was prefer-able to 600Ag of oral misoprostol in the activemanagement of the third stage of labor at hospitalswhere active management was the norm [19]. Thepossibly troubling bsecondary effectQ of oxytocin onmanual removal of the placenta needs clarification,as a 2004 Cochrane Review suggested that, with theprophylactic use of oxytocin, bthe risk of manualremoval of the placenta may be increasedQ [20]. Inhigh-resource countries, where embolism ratherthan PPH is the major cause of maternal mortality,hemorrhage requiring hysterectomy is consideredone of the most life-threatening conditions experi-enced by women during the perinatal period [21].Retained placenta represents a serious complicationrequiring manual removal, and such a bsecondaryoutcomeQ could be critical to consider when decid-ing on third-stage management protocols. Becausethe picture is not yet entirely clear, practitionersshould continually update themselves regardingavailable options, and health care agencies andgovernments planning units should be equallyvigilant about determining the best approach toadopt according to the available resources.

Although the literature suggests that activemanagement using standard oxytocic drugs canreduce PPH incidence by 40% [22], this method isfar from ideal in low-resource countries wheremany births are supervised by traditional birthattendants away from medical facilities and wherethe lethal PPHs are occurring.

The WHO study did not investigate whethermisoprostol was better than placebo. Two recenttrials of misoprostol, however, suggest favorableresults with this agent in low-resource countries.One, a field intervention trial in Tanzania followinghome births, demonstrated that 1000Ag of miso-prostol administered rectally by traditional birthattendants to women who lost 500mL of blood ormore decreased the need for referral and/orfurther treatment compared with a noninterven-tion group [23]. The other, a randomized, double-blind, placebo-controlled trial conducted amongwomen attended by midwives at local health

centers in Guinea—Bissau, concluded that 600Agof misoprostol routinely administered sublinguallyafter delivery reduced the frequency of severe PPH[24]. Both studies suggest that the safety ofdelivery is greater with misoprostol use, even whenthe women are attended by practitioners notbskilledQ by the WHO/ICM/FIGO definition.

An even more bolder method to deal with PPHwas tried in Indonesia, where 1811 women wereoffered counseling about PPH prevention andmisoprostol use by trained and supervised volun-teers. This study demonstrated that misoprostolwas safely used in a self-directed manner by thestudy participants who were delivered at home inthe intervention area [25]. Although misoprostol isavailable in most Asian and American countries, itsuse is restricted in many countries because of thefear that it will be used as an abortifacient. Thereis no access to this agent in most of Africa and muchof the Middle East, and only three countries, Brazil,Egypt, and France, have approved its use inobstetrics [26]. Given the potential benefits ofmisoprostol towards the major goal of the Millen-nium Development Goal No. 5—reducing maternalmortality—and the fact that WHO has added it to itslist of bessential medicinesQ [27], there appears tobe a role for FIGO, ICM, and the research commu-nity in closing the gaps in research as well asopening the barriers to the availability of thismedication.

5. Ongoing initiatives to prevent PPH

Every childbearing woman is potentially at risk forPPH, but biologic and/or physiologic considerationsare only part of the picture. Heathcare workersshould assume a stronger attitude of service andresponsibility in the larger public health issues,empowering women to seek help in a transformedhealth care culture. Moreover, when caring forindigenous populations and minority groups forgot-ten or subjugated by a dominant culture, moresensitive approaches respecting pregnancy andbirth as social and cultural events should beadopted. Incorporating traditional practitioners,e.g., the partera in Central America, into thehealth care team would be an important stepforward. It is crucial that physicians, midwives,and nurses work with communities and women’sgroups to bridge existing gaps in care.

An international group of researchers andexperts that included representatives of ICM andFIGO met in August 2003 in Ottawa, Canada, tocraft the Ottawa Statement on the prevention ofPPH and offer new options for its treatment. At the

Postpartum hemorrhage today: ICM/FIGO initiative 2004—2006 247

last World Congress of FIGO in Chile, in 2003,President Arnaldo Acosta announced that FIGO, inpartnership with ICM, would launch an initiative topromote active management of the third stage oflabor (AMTSL) to prevent PPH, and increase theknowledge of nurses, midwives, and physicians inthe medical and surgical treatment of PPH. BothFIGO and ICM are collaborating with the Programfor Appropriate Technology for Health to conductthe Prevention of Postpartum Hemorrhage Initia-tive. Launched in October of 2004, this project hascreated tool kits and educational modules toimplement AMTSL and has also provided smallgrants to countries, so that FIGO- and ICM-memberassociations and societies may collaborate tospread the use of AMTSL. These initiatives havebeen prompted, in large part, by the fact that pastefforts did not substantially decrease maternalmortality and morbidity. Procedures for PPH pre-vention and treatment are well known and provento be beneficial, but they are not readily availableto many health workers and pregnant women.

6. Joint statement and action planlaunched in 2004 by ICM/FIGO

bManagement of the third stage of labor should beoffered to women since it reduces the incidence ofpostpartum hemorrhage due to uterine atony.Q

Active management of the third stage of laborconsists of interventions designed to facilitate thedelivery of the placenta by increasing uterinecontractions and to prevent PPH by avertinguterine atony. The usual components include

! Administration of uterotonic agents;! Controlled cord traction; and! Uterine massage after delivery of the placenta,as appropriate.

Every birth attendant must have access toneeded supplies and equipment and acquire theknowledge, skills, and critical judgment to carryout active management of the third stage of labor.

6.1. How to use uterotonic agents

! Following delivery, palpate the abdomen to ruleout the presence of additional fetuses and giveoxytocin 10 IU intramuscularly (IM). Oxytocin ispreferred to other uterotonics because it iseffective 2—3min after injection; and havingminimal secondary effects, it can be used in allwomen.

! If oxytocin is not available, other uterotonicscan be used such as ergometrine 0.2mg IM;syntometrine (1 ampoule) IM; or misoprostol400—600Ag orally. Oral administration of miso-prostol should be reserved for situations whensafe administration and/or appropriate storageconditions for injectable oxytocin and ergotalkaloids are not possible.

! Uterotonics require proper storage:o Ergometrine: 2—88C, protected from lightand freezing;

o Misoprostol: room temperature, in a closedcontainer;

o Oxytocin: 15—30 8C, protected fromfreezing.

! Counseling on the secondary effects of thesedrugs should be given.

Warning! Do not give ergometrine or syntome-trine (which contains ergometrine) to women withpre-eclampsia, eclampsia, or high blood pressure.

6.2. How to perform controlled cord traction

! Clamp the cord close to the woman’s perineum(once pulsation stops in a healthy newborn) andhold it in one hand;

! Place the other hand just above the woman’spubic bone and stabilize the uterus by apply-ing counter-pressure during controlled cordtraction;

! Keep a slight tension on the cord and wait for astrong uterine contraction (2—3min);

! With the strong uterine contraction, encouragethe mother to push and very gently pull down-ward on the cord to deliver the placenta.Continue to apply counter-pressure to the uterus;

! If the placenta does not descend during 30—40 sof controlled cord traction, do not continue topull on the cord:

o Gently hold the cord and wait until theuterus is well contracted again;

o With the next contraction, repeat controlledcord traction with counter-pressure.

Never apply cord traction (never pull) withoutapplying counter-traction (push) above the pubicbone on a well-contracted uterus.

! As the placenta is being delivered, hold it in twohands and gently turn it until the membranes aretwisted. Slowly pull to complete the delivery;

! If the membranes tear, gently examine the uppervagina and cervix wearing sterile or disinfectedgloves, and use a sponge forceps to remove anypieces of membrane that are present;

A. Lalonde et al.248

! Carefully examine the placenta to ensure thatnone of it is missing. If a portion of the maternalsurface is missing, or there are torn membraneswith vessels, suspect retained placenta frag-ments and take appropriate action [27].

6.3. How to perform uterine massage

! Immediately massage the fundus of the uterusabdominally until the uterus is contracted;

! Palpate for a contracted uterus every 15min andrepeat uterine massage as needed during thefirst 2h;

! Ensure that the uterus does not become relaxed(soft) or bboggyQ after you stop uterine massage.

In all of the above actions, explain the proceduresand actions to the woman and her family. Continueto provide support and reassurance throughout.

7. Important changes to consider inactive management protocols

There is evidence suggesting that immediate cordclamping may reduce the quantity of red bloodcells a newborn receives, possibly causing short-and long-term problems. Because prior concernsabout polycythemia have not been documented[28], the collaborative ICM/FIGO group decided notto include early cord clamping in the activemanagement protocol. This decision means thatthe present definition of active management pro-mulgated by ICM/FIGO differs from that describedin earlier publications.

FIGO now also advises that if oxytocin or miso-prostol are unavailable, skilled birth attendantsshould use physiologic (or expectant) managementof the third stage. Thismeans that, to avoidmaternaloverexertion, they should not begin cord tractionbefore the uterus has contracted and the placenta’sexpulsion has begun. This is best described asallowing the mother to expel her own placentawithout interference from the practitioner.

8. The role of national professionalorganizations

The following points outline the 10 key actions thatare being promoted worldwide by FIGO/ICM toprevent PPH and manage it when it occurs:

(1) Disseminate the joint statement to all nation-al associations of midwives and societies of

obstetrician—gynecologists, and encouragethe national groups to disseminate it to theirmembers.

(2) Obtain support for the joint statement fromagencies in the field of maternal and neonatalhealth care, such as UN and non-UN develop-ment agencies.

(3) Recommend that this Global Initiative on theprevention of PPH be integrated into themidwifery curricula of medical and nursingschools.

(4) Recommend that the Global Initiative beadopted by health policy makers andpoliticians.

(5) Every mother giving birth anywhere in theworld will be offered active management ofthe third stage of labor for the prevention ofPPH.

(6) Every skilled attendant will have training inactive management of the third stage of laborand in techniques for the treatment of PPH.

(7) Every health facility where births take placewill have adequate equipment and suppliesof uterotonic drugs, as well as protocols inplace for the prevention and treatment ofPPH.

(8) There will be blood transfusion facilities inall centers that provide comprehensivehealth care (secondary and tertiary levelsof care).

(9) Physicians will be trained in simple conserva-tive techniques such as compression suturesand devascularization [29].

(10) Promising new drugs and technologies forthe prevention and treatment of PPH, suchas the tamponade technique, are beingevaluated.

National professional associations also have animportant and collaborative role to play in thefollowing areas:

! Advocacy for skilled care at birth;! Public education about the need for adequateprevention and treatment of PPH;

! Publication of the statement in national mid-wifery, obstetric, and medical journals as well asin newsletters and on Web sites;

! Dealing with legislative and other barriers thatimpede the prevention and treatment of PPH—which includes confronting poverty and malnu-trition as well as incorporating active manage-ment of the third stage of labor into pre-serviceand in-service curricula for all skilled birthattendants;

Postpartum hemorrhage today: ICM/FIGO initiative 2004—2006 249

! Incorporating active management of the thirdstage of labor in national standards and clinicalguidelines, as appropriate;

! Working with national pharmaceutical regulato-ry agencies, policymakers, and donors to ensurethat adequate supplies of uterotonics and injec-tion equipment are available.

In order to assess the situation and send aidwhere strategically feasible, FIGO/ICM developed adetailed questionnaire on:

! The cost and availability of oxytocics around theworld, who is allowed to use them and underwhat circumstances, how they are stored, andthe plans and obstacles to place utertonics in thehands of those who need them;

! The present practice protocols of the varioussocieties with regards to management of thethird stage and the training available;

! The working definition of active management ofthe third stage in every country;

! The key actions the member associations areundertaking or are willing to undertake.

Results will be presented at the FIGO WorldCongress in 2006 in Kuala Lumpur.

Figure 1 The SOS Bakri Tamponade Balloon Catheter.

9. Two new tools: the anti-shock garmentand the tamponade test

9.1. The anti-shock garment

A new type of anti-shock garment has beendeveloped, which reverses the effect of shock onthe body’s blood distribution. It is best described asa giant blood pressure cuff that applies externalcounter-pressure to the legs and abdomen. Basedon the principle that the brain, heart, and lungs ofa person in shock incur a loss of oxygen becauseblood accumulates in the lower abdomen and legs,the anti-shock garment returns blood to the vitalorgans, thus stabilizing body pressure until ahospital can be reached.

The Cochrane Review reveals no evidence thatusing medical anti-shock trousers (or pneumaticanti-shock garments) for circulatory supportreduces mortality length of hospitalization, orlength of stay in the intensive care unit for patientswith trauma, and these garments may even increasethese indicators [30]. However, the Cochrane Re-view cautions about the poor quality of the trials anddata. Moreover, a trial of the nonpneumatic anti-shock garment (NASG) is presently conducted in

Egypt, Nigeria, and Mexico by Suellen Miller, fromthe Women’s Global Health Imperative. Preliminaryresults from the pilot Egypt study suggest that,compared with women in the control group in whomthe NASGwas not used, bleeding decreased by 50% inwomen experiencing various forms of obstetricalhemorrhage (e.g., ruptured ectopic pregnancy,postabortion complications, or PPH) in whom theNASG was used [32]. The use of this device could becritical to decrease MMRs by avoiding the seconddelay in low-resource settings—reaching a healthfacility.

10. The tamponade test

The following is a summary of a written descriptionof the tamponade test by Dr. Sabaratnam Arulku-maran, Professor and Head of the Division ofObstetrics and Gynecology at St. George’s HospitalMedical School in London, England.

A survey in the UK showed that hysterectomywas the most common surgical procedure in womenwho did not respond to a combination of uterotonicdrugs [31]. As invasive surgery following a PPH cancause additional blood loss and a long convales-cence, alternative procedures are being sought,and the tamponade test is a nonsurgical approach(Fig. 1). If used as soon as uterotonics are foundineffective, the tamponade test could both reducethe amount of blood lost and indicate whetherdefinitive surgery is needed within minutes. It maybe useful in women incurring PPH of nontraumaticcauses, and when there is no retained tissue in theuterus. It is hypothesized that total blood loss andthe need for blood transfusion, laparotomy, andeven hysterectomy—with their related risk—may

A. Lalonde et al.250

be avoided by a modern version of this oldtechnique.

10.1. Rationale for the tamponade test

The first-aid technique to stop a vessel frombleeding following an injury is to apply a tourni-quet, or else apply pressure proximally to thebleeding vessel. Applying sufficient pressure tocompress the blood vessel often brings resolu-tion—the bleeding has stopped when the bandageis removed several hours later. This techniqueworks because the pressure on the blood vessel isgreater than the pressure within the vessel. Ifpressure is applied long enough, the blood may clotand form a permanent seal.

Blood flows into the uterus with a pressure of120/80mm Hg, for a mean arterial pressure of90mm Hg. The spiral arteriolar arrangement in theuterus might lower the arterial pressure with whichthe blood enters the uterus. When the placentaseparates, the venous sinuses and the spiralarterioles are exposed and bleeding occurs fromthe placental bed. If uterine atony continues afteroxytocics are given, bimanual compression is un-dertaken while local trauma is ruled out as thesource of bleeding. Exploration under anesthesia isoften undertaken to remove products that may beretained within the uterus and to determinewhether any trauma to the uterus or lower genitaltract may be the source of bleeding. If the bleedingis due to uterine atony, i.e., the failure of the livingligatures to stop the bleeding, a tamponade testwould help decide whether the uterine tamponadeitself would be therapeutic, or whether laparotomyis needed.

10.2. History

In the past, uterine tamponade was achieved bypacking the uterus with cotton gauze, a techniquewhich had several disadvantages. General, spinal,or epidural anesthesia was needed, and becausethe packing was done blindly, it was not knownwhether it filled the entire uterine cavity. More-over, the fear of perforation often led to inade-quate packing; and whether the packing waseffective was not known for several minutes, asthe blood had to soak the pack before reachingthe cervix. To overcome some of these difficulties,a sterile plastic bag was first introduced into theuterus, and then packed with gauze; but theprocess was cumbersome, took time, and wasnot always effective [32]. The interest of themedical community for uterine tamponade has

been revived by the appearance of the balloontamponade.

10.3. How balloon tamponades are used

Several reports describe the successful treatmentof PPH using a hydrostatic balloon tamponade,either alone or in combination with additionalsurgical methods [33,34]. The most commonly usedballoon has been the Sengstaken—Blakemore tube,used by surgeons for decades to arrest bleedingfrom esophageal varices. Fig. 1 shows the SOS BakriTamponade Balloon Catheter. It is the aim of FIGOto lobby to make these devices less expensive thanthey are presently.

Steps to their use are as follows:When uterotonics and uterine massage do not

stop the bleeding, the patient is checked for localtrauma or retained tissue in the uterus. Then,under spinal, epidural, or general anesthesia, aballoon catheter (sterilized by gas or by soaking in2% glutaraldehyde solution for 20min) is insertedinto the uterine cavity. A vaginal examination ordirect visualization to identify the cervix facilitatesinsertion. For direct visualization, a vaginal spec-ulum is introduced and the anterior lip of the cervixis secured with a sponge forceps. When theSengstaken—Blakemore stomach device is used,the distal tube is cut and removed to facilitateinsertion and retention in the uterine cavity andthe balloon part, held with another sponge forceps,is inserted into the uterine cavity.

Once the balloon has been placed in the uterinecavity, an assistant is asked to fill it with warmsterile water or a warm saline solution. About100—300mL could be used, but overfilling theballoon may cause it to bulge out of the cervixand be expelled. For this reason, the balloon wallshould be distensible, but not so distensible thatincreasing pressure causes it to herniate throughthe cervix. In case reports, the volume used variesfrom 80 to 300mL. The practice has been to fill theballoon until it becomes visible in the cervixlumen.

At this stage, if there is no bleeding through thecervix or through the drainage channel of theballoon catheter, the test result is pronouncedsuccessful and no further fluid is added. If thebleeding continues, the result is unsuccessful andsurgery is needed.

Further research is in progress to make catheterballoons more effective by measuring the innerpressure of the balloon part. When the pressureexceeds that of the patient’s blood pressure, noadditional fluid needs to be added and the bleedingshould stop. If the bleeding does not stop and does

Postpartum hemorrhage today: ICM/FIGO initiative 2004—2006 251

not originate in the lower genital tract, then theneed for surgery via laparotomy is indicated.

Whether the tamponade will be successful isknown within minutes. Once it is found to besuccessful, the uterine fundus is palpated abdom-inally and a mark is made with a pen as areference line from which any uterine enlarge-ment or distension would be noted during theperiod of observation.

10.4. Care after tamponade

The patient should be kept under constant surveil-lance after insertion of the tamponade ballooncatheter. Her pulse, blood pressure, uterine fundalheight, and signs of any vaginal bleeding orbleeding through the lumen of the catheter shouldbe noted every half hour. Her temperature shouldbe recorded every 2h and urinary output measuredhourly via an indwelling Foley catheter.

Since a foreign body is introduced and willremain in place for hours, the woman shouldreceive broad-spectrum antibiotics from the timeof insertion for up to 3days. At St. George’sHospital Medical School, ampicillin and metranida-zole are administered intravenously on day 1,followed by 2 more days of oral antibiotics. If thewoman is sensitive to penicillin, erythromycin orcephalosporin is prescribed.

A low-dose infusion of oxytocin (40 IU in a liter ofnormal saline solution) is continued until theballoon is withdrawn to keep the uterus con-tracted. After 6—8h, if the uterine fundus remainsat the same level, and there is no active bleedingthrough the cervix or the central lumen of thecatheter, it is safe to remove the balloon providedthat the woman is stable and adequate bloodreplacement has been provided.

The balloon removal procedure is as follows: Themother is kept fasting in case surgery is neededunder anesthesia. First, the balloon is deflated, butnot removed for 30min, during which the oxytocininfusion is continued even if there is no bleeding. Ifthere is still no bleeding after these 30min, theoxytocin infusion is stopped and the ballooncatheter removed. In this way, if the woman startsbleeding when the balloon is deflated or theoxytocin stopped, the balloon can be inflatedagain. In the experience at St. George’s HospitalMedical School with more than 30 cases, there wereno cases when the balloon needed to be refilled[33]. Six hours seem to be sufficient for theplacental bed to clot and stop bleeding.

To date, no immediate problems such as bleed-ing or sepsis, or long-term complications such asmenstrual problems or problems with conceiving,

have been reported in women who underwentuterine tamponade.

10.5. The evidence for tamponade

The largest case series consists of 16 consecutivecases in which the tamponade test was used as a lastmeasure before embarking on a laparotomy [33].The bleeding stopped immediately in 14 patients,and no additional intervention was required. Evenwhen the bleeding did not stop, the quantity ofbleeding was markedly reduced, allowing enoughtime to stabilize the two patients prior to surgery.The amount of blood collectively lost by the 16patients was estimated at 50L, and together thesewomen received 99 units of blood, 36 units of fresh-frozen plasma, 23 units of platelets, and 180mL ofcryoprecipitate. Although more research is needed,it would seem that the tamponade test could havebeen introduced earlier to reduce bleeding inprimary or secondary PPH; after a second-trimestermiscarriage; and in some cases after a cesareansection—provided that there is no spontaneous orsurgical trauma and no retained tissue in the uterus.The tamponade test could be particularly effectivein reducing the MMR of low-resource countries, as itcan be performed by staff of little training in smallcenters with minimal facilities.

11. The clinical classification ofhypovolemic shock

Mild shock occurs when about 20% of the bloodvolume is lost and there is decreased perfusion ofnonvital organs and tissues (skin, fat, skeletalmuscle, and bone), with pale, cool skin and afeeling of growing cold. Moderate shock occurswhen 20—40% of the blood volume is lost and thereis decreased perfusion of vital organs (liver, thegut, and kidneys), oliguria and/or anuria, a slight tosignificant drop in blood pressure, and mottling inthe extremities, especially the legs. Severe shockoccurs when 40% or more of the blood volume is lostand there is decreased perfusion to the heart andbrain, restlessness, agitation, coma, cardiac irreg-ularities, electroencephalographic abnormalities,and possibly cardiac arrest.

11.1. Hemorrhagic shock and the concept ofthe golden hour

Severe, acute blood loss can lead to cardiovascularfailure. Severity depends on body weight, hemo-globin levels, and body metabolism. For instance, a

A. Lalonde et al.252

blood loss of 1.5L causes severe shock in a womanweighing 48kg but only a mild shock in a womanweighing 84kg.

As more time elapses between the onset ofsevere shock and resuscitation, the percentage ofsurviving patients decreases because metabolicacidosis sets in. The golden hour is the time atwhich resuscitation must begin to ensure the bestchance of survival. The probability of survivaldecreases sharply after the first hour if the patientis not effectively resuscitated.

11.2. An algorithm for action

An algorithm has been suggested for the manage-ment of atonic PPH. It is called

H.A.E.M.O.S.T.A.S.I.S.

H: Ask for helpA: Assess (vital parameters, blood loss) and

resuscitateE: Establish etiology and check medication

supply (syntometrine, ergometrine, bolussyntocinon) andavailability of blood

M: Massage uterusO: Oxytocin infusion, prostaglandins (intrave-

nous, rectal,intramuscular, intra-myometrial)

S: Shift to operating room, exclude retainedproducts and trauma, bimanual compression

T: Tamponade balloon, uterine packingA: Apply compression suturesS: Systematic pelvic devascularization (uter-

ine, ovarian, quadruple, internal iliac)I: Intervention radiologist, uterine artery em-

bolization if appropriateS: Subtotal or total abdominal hysterectomy.

12. Conclusion

Tourists flock to the Taj Mahal, unaware that theevent symbolized by this monument still occurscontinually around the world—in the shadows of awoman’s blood-soaked dirt floor; of a desperatehusband’s rough cart dragged through bad roads,which does not arrive in time; of the sad eyes of abasic health unit nurse. Governments have beenslow to prioritize women’s health and donorcountries have not shown sufficient commitmentto dealing withmaternal mortality; and yet, povertyreduction and education were supposed to beacknowledged as the keys to good health—the motto

was to be that there is no health withouteducation and no education without health [35].

To address the PPH issue, ICM and FIGO havelaunched a worldwide initiative to promote activemanagement of the third stage of labor for allwomen. Further research is needed about thebenefits and possible adverse effects ofmisoprostol,oxytocin, the anti-shock garment, and the balloontamponade. Both organizations need governments,donor countries, and the public to support thecampaign that will help address Millennium Devel-opment Goal No. 5. The professional associations arerespectfully requested to join the ICM/FIGO coali-tion and contribute to the prevention and treatmentof PPH. They can do so by working with theirministries of health on the broader issues of poverty,nutrition, women’s status, and access to medicationand education and persuade them to adopt the low-cost medico-surgical approaches just discussed. Acommunity and national infrastructure designed inSweden in the 1700s would still represent a giant’sstep toward FIGO’s Millennium goal to savemothers,and the time appears to be right to seize the answersthat have been staring us in the face for some time.

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