zimbabwe moh vsi pph brief 2013 09...
TRANSCRIPT
Introducing Misoprostol for the Management of Postpartum Hemorrhage in Zimbabwe Final Report in Brief Introduction Postpartum hemorrhage (PPH) is the most common cause of maternal mortality globally, leading to a woman’s death every seven minutes.1 In Zimbabwe, there has been a 300% increase in the maternal mortality ratio (MMR) between 1994 and 20102 and the MMR was estimated at 960 maternal deaths per 100,000 live births in 2012.3 Overall, 14% of all maternal deaths in Zimbabwe are due to PPH.4 Ensuring prompt access to high-‐quality prevention and treatment of PPH for all women who deliver is an essential strategy to combat PPH-‐related morbidity and mortality and to make progress toward reaching Millennium Development Goal 5, the reduction of maternal mortality by three-‐quarters by 2015. Background The Zimbabwe Ministry of Health and Child Welfare (ZMoHCW) is committed to improving maternal health as outlined in the National Maternal and Neonatal Health Roadmap 2007-‐2015. The roadmap presents evidence-‐based strategies for reversing the decline in maternal health, including the procurement and distribution of essential maternal health commodities.5 Misoprostol, an effective, safe, low-‐cost and heat stable uterotonic in tablet form, is recommended by the World Health Organization (WHO) for both PPH prevention and treatment.6 The ZMoHCW aims to increase the availability of misoprostol throughout the country, with the ultimate goal of ensuring that every Zimbabwean woman has access to a uterotonic drug at the time of delivery.
Misoprostol as an Evidence-‐based Strategy for PPH Management Based on recent evidence, the WHO identified the use of uterotonics as the key intervention within the active management of third stage of labor (AMTSL) package, and recommends that all women giving birth should be offered uterotonics for the prevention of PPH.6 Oxytocin is recommended as the uterotonic drug of choice, for the prevention and treatment of PPH, and misoprostol is recommended in settings where oxytocin is unavailable or cannot be safely used.6 The WHO also supports the use of misoprostol for the prevention of PPH by community health care workers and lay health workers that are trained in misoprostol use in settings where skilled birth attendants are not present.6 Misoprostol is included in
the WHO Model List of Essential Medicines7 for PPH prevention; as well as in the Priority Life-‐saving Medicines for Women and Children.8 Furthermore, it is included in the life-‐saving commodities list for PPH prevention by the United Nations’ Commission on Life-‐saving Commodities for Women and Children,9 whose goal is to increase the supply and use of essential commodities. Through the work of the Misoprostol Technical Working Group hosted within the ZMoHCW, misoprostol is included in the 2011 Essential Drugs List of Zimbabwe (EDLIZ) for obstetric indications. The ZMoHCW BEmONC Facilitator’s Manual10 also integrates misoprostol use for PPH prevention and treatment when oxytocin is not available. An important next step in Zimbabwe to ensure ongoing product availability is the
registration of a quality misoprostol product for these obstetric indications. The ZMoHCW and Venture Strategies Innovations (VSI), a US-‐based non-‐profit organization with operations in Harare, collaborated to conduct operations research (OR) to provide evidence on the feasibility and effectiveness of integrating misoprostol for PPH prevention and treatment for use at all levels of health facilities, when oxytocin is not available or cannot be safely used. The evidence presented in this brief is intended to guide the ZMoHCW’s plans for scaling up the integration of misoprostol into Zimbabwe’s health care system to expand coverage of uterotonics to all women giving birth, and to support the registration of misoprostol for obstetric indications. Operations Research: Background The ZMoHCW’s and VSI’s collaborative OR was conducted in 68 health facilities in four districts of Zimbabwe: Chimanimani, Matobo, Mutare, and Umguza. The districts were selected with the aim of representing the country’s diversity in geography, resources, and political affiliation. The OR sites included one provincial hospital, three district hospitals, 13 rural and mission hospitals and 51 rural health centers (RHCs) (Figure 1). A training of trainers was conducted for 40 senior doctors and nurses, followed by cascade trainings for 135 primary care nurses, nurses and midwives from all sites.
A baseline facility assessment was conducted at the 68 facilities prior to the introduction of misoprostol. Staff interviews and record reviews were conducted for services provided from September 2011 to February 2012 to collect information on the number of deliveries, PPH management practices, drug supplies, staffing, and facility infrastructure. During the OR, which refers to the period from January to June 2013 where misoprostol was made available at all facilities, PPH management practices were monitored for six months. Monitoring data were collected from Delivery Registries that were revised to include details about uterotonic provision for both PPH prevention and treatment. Focus group discussions were held with Village Health Workers to identify a tool for measuring blood loss during home deliveries, and a community education campaign was conducted on topics that included
birth preparedness, the importance of a facility delivery, how to recognize signs of excessive bleeding, and the availability of drugs to prevent bleeding at facilities. These messages were incorporated into routine antenatal care (ANC) education sessions and community meetings, and presented on a poster that was displayed in key community sites. The current ZMoHCW BEmONC guidelines outlining the steps for active management of the third stage of labor (AMTSL) require the administration of a uterotonic to all women who give birth immediately after delivery. In line with the WHO recommendations, the ZMoHCW guidelines also recommend oxytocin as the first-‐line drug for PPH prevention while misoprostol is recommended for use when no other uterotonic is available, or as a second-‐line drug when oxytocin or ergometrine has failed.10 Similarly, the service delivery protocol for the
Figure 1: Districts and health facilities that participated in the operations research
MUTARE DISTRICT!Pop. = 434,379!
Rural Health Center = 20!Rural/Mission Hospital = 3!
District Hospital = 1!Provincial Hospital = 1!
CHIMANIMANI DISTRICT!Pop. = 136,055!
Rural Health Center = 15!Rural/Mission Hospital = 5!
District Hospital = 0!Provincial Hospital = 0!
MATOBO DISTRICT!Pop. = 110,266!
Rural Health Center = 8!Rural/Mission Hospital = 4!
District Hospital = 1!Provincial Hospital = 0!
UMGUZA DISTRICT !Pop. = 81,781!
Rural Health Center = 8!Rural/Mission Hospital = 1!
District Hospital = 1 Provincial Hospital = 0!
HARARE!
OR included misoprostol for PPH prevention when oxytocin was not available, and misoprostol as an additional option for the treatment of PPH. The OR service delivery and referral protocols are summarized in Figure 2. Operations Research: Key Findings Maternity Services A total of 8,258 deliveries were recorded at the OR facilities from January to June 2013. Of those, 259 were caesarean sections, and 528 women delivered at home or on the way to the hospital, which left a total of 7,400 vaginal deliveries at
the facilities in the OR districts. Place of delivery was not recorded for 71 women. Over one-‐fourth (n=2,147) of vaginal facility deliveries for which facility level data was available took place at the RHCs, with another ten percent (n=730) at the rural hospitals. Almost one-‐third took place at a district hospital (n=2,308), while around 15% took place at both mission hospitals (n=1,064) and the provincial hospital (n=1,134). Almost two-fifths (n=2,877) of facility deliveries took place at rural health centers and rural hospitals.
Increasing the capacity of these facilities to manage PPH, through trained staff and necessary equipment and supplies, is essential. Uterotonic Availability and Utilization While oxytocin was available at over 90% of the facilities at the time of the baseline assessment, over half of the facilities (56%) reported having had a stock-‐out in the past six months.i The mean duration of
i Oxytocin availability and stock-‐out information was collected through staff interviews at the sites.
!Oxytocin infusion, 40 units at
30-40 drops/minute!!
OR, IF OXYTOCIN NOT AVAILABLE!
!Ergometrine 0.5 mgs, IM or IV*!
!
OR, IF ERGOMETRINE NOT AVAILABLE!
!Misoprostol 800 mcg sublingual!!SURGICAL INTERVENTION, IF NECESSARY AND AVAILABLE!!
!!!
!!!!
Oxytocin, 10 units IM!!
OR, IF OXYTOCIN NOT AVAILABLE!
!Ergometrine 0.5 mgs, IM or IV*!
!
OR, IF ERGOMETRINE NOT AVAILABLE!
!Misoprostol 800 mcg sublingual!
!!!!
!!!!
!!!
Oxytocin infusion, 40 units at 30-40 drops/minute!
!
OR, IF OXYTOCIN NOT AVAILABLE!
!Ergometrine 0.5 mgs, IM or IV!!
OR, IF ERGOMETRINE NOT AVAILABLE!
!Misoprostol 800 mcg sublingual!
!SURGICAL INTERVENTION IF
NECESSARY!!!!
!!
Bleeds > 500 ml (PPH)!
!Perceived PPH!
!!
Bleeds > 500 ml (PPH)!
!!
Bleeds > 500 ml (PPH)!
Provincial/Central Hospitals!District Hospital!Home! Rural Health Center!
!!!!!!!!!!!!!!!!!!!!!
!!!!!!!!!!!!!!!!!!!!
!!!!!!!!!!!!!!!!!!!!
10 IU oxytocin, IM !If oxytocin NOT available!600 mcg misoprostol oral!
10 IU oxytocin, IM !If oxytocin NOT available!600 mcg misoprostol oral!
Self refer to health facility, treatment according to
facility guidelines!
No uterotonic!
!!!!!!!!!!!!!!!!!!!!
10 IU oxytocin, IM!If oxytocin NOT available, !600 mcg misoprostol oral!
Refer if woman continues to bleed or has a
deterioration in vital signs ! *Facility treatment regimens are the same for all women with PPH, regardless of what, if any, uterotonic was used for PPH prevention!
PREVENTION !!!!TREATMENT!
Refer if woman requires a surgical intervention not available at the district
hospital!
Figure 2: Service delivery and referral protocols for PPH prevention and treatment, based on the level of facility and availability of uterotonics*
stock-‐outs was highest at rural health centers (52 days) and mission hospitals (14 days). Only the provincial hospital did not report a stock-‐out in that period. Although misoprostol had been included in the ZMoHCW guidelines for PPH prevention when oxytocin is not available, it was found to be available in only 6% of facilities at the time of the baseline assessment. It was primarily the district and provincial hospitals that had misoprostol; only one RHC and one rural hospital reported misoprostol in stock at the time of the baseline assessment. In the baseline assessment, nearly 40% of the RHCs reported not having electricity or a power source, which is essential for refrigerating oxytocin and ensuring its stability, especially when stored for over a few months. In addition, monthly power outages were reported at all facility levels, with the exception of the provincial hospital. Even when oxytocin is available, the additional availability of misoprostol will help to overcome possible challenges with oxytocin, such as a lack of ideal storage conditions, stock-‐outs, or shortages of providers who are authorized to administer injections. During the OR, misoprostol was regularly provided to all 68 facilities. Ensuring a supply of misoprostol, especially at rural health centers and rural hospitals, is an effective strategy for increasing overall uterotonic coverage.
According to the baseline assessment of records from September 2011 to February 2012, all women who delivered in a provincial or district hospital received a uterotonic for PPH prevention. In contrast, during that same period, 19% of women who delivered at a RHC and 22% of those delivering at the rural hospitals did not receive any uterotonic for PPH prevention. Qualitative data from interviews with providers at rural facilities suggested that stock-‐outs and limited availability of uterotonics were the two primary reasons for women not receiving a uterotonic for PPH prevention. Providers reported that with limited availability of oxytocin, the drug was sometimes reserved for treatment rather than given for prevention. PPH Prevention Near universal uterotonic coverage for PPH prevention at facility deliveries (99%) was achieved during the OR. Misoprostol contributed significantly to this high coverage
(Table 1). Of the women who delivered at a facility for whom district and uterotonic for PPH prevention were recorded, 88% received oxytocin, 9% received misoprostol, 3% received ergometrine and 1% received no uterotonic. Misoprostol use was highest in Matobo and Chimanimani districts, where 12% and 11% of vaginal deliveries received misoprostol for PPH prevention, respectively. In terms of uterotonic coverage for all births, the impact was greatest at the RHCs and rural hospitals where baseline coverage rates were lowest. At RHCs, coverage increased from 81% to 97%, while at rural hospitals, it rose from 78% to 99% (Figure 3). Where uterotonic coverage was high at baseline (for mission, district and provincial hospitals at 99% to 100%), the coverage was unchanged. The use of misoprostol during the OR was higher at the RHCs and rural hospitals than at the other types of
Table 1: Uterotonic used for PPH prevention among women who had a vaginal delivery at a facility, by district (January – June 2013)*
*There were 8 women with missing information on uterotonic used, district, or both.
District
Total (n=7,392)
Chimanimani (n=1,512)
Matobo (n=678)
Mutare (n=4,833)
Umguza (n=369)
Uterotonic used for PPH prevention
Oxytocin 1,166 (77.1%)
596 (87.9%)
4,382 (90.7%)
348 (94.3%)
6,492 (87.8%)
Misoprostol 160 (10.6%)
80 (11.8%)
366 (7.6%)
19 (5.2%)
625 (8.5%)
Ergometrine 150 (9.9%)
1 (0.2%)
42 (0.9%)
1 (0.3%)
194 (2.6%)
No uterotonic
36 (2.4%)
1 (0.2%)
43 (0.9%)
1 (0.3%)
81 (1.1%)
Total women protected with a uterotonic
1,476 (97.6%)
677 (99.9%)
4,790 (99.1%)
368 (99.7%)
7,311 (98.9%)
facilities. Over the six months, at RHCs, 21% of maternity cases that were vaginal deliveries and for whom uterotonic data was available were given misoprostol for PPH prevention. At rural hospitals, the corresponding figure was 16%. As expected, misoprostol use for PPH prevention was less significant at the district and provincial hospitals, where it was administered for PPH prevention to less than one percent of women with vaginal deliveries (n=15). Misoprostol played a significant role in ensuring women’s access to a uterotonic for PPH prevention at rural health centers where it was administered to one in five women with vaginal deliveries. Including misoprostol as an available uterotonic for PPH prevention resulted in almost universal (99%) uterotonic coverage at facility deliveries.
Correct Administration of Misoprostol for PPH Prevention Training and instruction on dose and route of administration was given to health providers during the OR trainings, supervisory visits, and on misoprostol regimen cards (Figure 4). Provider adherence to instructions was high. A correct regimen of 600mcg orally was administered to all women with a vaginal delivery for whom data was recorded. PPH Treatment As per service delivery and referral protocols in the OR, 800 mcg sublingual misoprostol was to be used as a treatment method for PPH at all levels of the health system if oxytocin was not available or had failed as prevention (Figure 2). A total of 259 PPH cases among women with vaginal deliveries, for whom data was available on treatment and facility level, were recorded at the OR sites from
January to June 2013. Overall, 10% were treated with misoprostol. Misoprostol played the greatest role in PPH treatment at the RHCs and rural hospitals. Over 40% of the total number of PPH cases were treated at these two levels of facilities. At RHCs, 19% (n=15) of the PPH cases were treated with misoprostol; over one-‐fourth (27%; n=6) of the PPH cases at the rural hospitals were treated with misoprostol. The availability of misoprostol played a significant role in the treatment of women suffering from PPH, particularly women living in rural areas who would have had more difficulty reaching a referral hospital in an urban area in a timely fashion. Rural women, who are more likely to confront barriers related to cost, availability of transport and cultural barriers that limit their access to timely maternity services, benefited most from the availability of misoprostol for PPH treatment. Community Education Sessions Two focus group discussions (FGDs) were held with 21 Village Health Workers in order to identify a culturally acceptable means of measuring blood loss at home deliveries. Community education sessions held during the operations research incorporated messages from the key findings from the FGDs. These key findings included: 1) Village Health Workers believed that measuring blood loss at home deliveries with two zambias was a culturally acceptable means of blood loss measurement; 2) local stakeholders (village headmen, krawl heads, mothers-‐in-‐law) should
Figure 3: Proportion of facility deliveries at rural health centers and rural hospitals receiving a uterotonic for PPH prevention, at baseline and during the operations research
81%!78%!
97%! 99%!
50%!
60%!
70%!
80%!
90%!
100%!
Uterotonic coverage at Rural Health Centers !
Uterotonic coverage at Rural Hospitals!
Baseline (Sept 2011-Feb 2012)!
Operations Research (Jan-June 2013)!
n=2,824! n=2,148! n=730!n=764!
be actively involved in relaying messages about safe delivery; and 3) a variety of information channels should be used to disseminate community education information, including community demonstrations and dramas, home visits to pregnant women, and group education sessions at health facilities. Over the course of the OR, 17,134 community members were reached with community education messages. Future Opportunities The ZMoHCW encourages all women to deliver at a health facility in order to be assisted by a skilled birth attendant. Recent government investments in maternity waiting
homes and ambulances, and a policy change that removes charges for maternity care at government facilities, are likely to increase the percentage of deliveries that take place in health facilities. Yet an estimated 34% of women currently deliver at home in Zimbabwe.3 Many of these women will not receive any uterotonic for PPH prevention, and a portion of those suffering from PPH will not reach a health facility in time to prevent death or disability. Numerous studies have demonstrated that misoprostol can be used safely and effectively at the community level11 and the WHO recommends misoprostol use by community health care workers and lay health
workers for PPH prevention in settings where skilled birth attendants are not present and oxytocin is unavailable.6 The available evidence suggests that advance distribution of misoprostol for home births will not interfere with efforts to increase facility-‐based deliveries.12,13
Conclusions The OR provides strong evidence of the role that misoprostol can play in the management of PPH, particularly at RHCs and at rural hospitals, where maintaining a regular supply of oxytocin under optimal conditions can present greater challenges. Providers at these lower-‐level facilities were able to correctly
CERVICAL RIPENINGDose Route Instructions
400 mcg Vaginal or sublingual Give 3 hours before the procedure.
INTRAUTERINE FETAL DEATHReduce doses in women with not use with previous cesarean section.
Dose Route Instructions13-17 weeks200 mcg Vaginal Every 6 hours, maximum 4 doses.18-26 weeks100 mcg Vaginal Every 6 hours, maximum 4 doses.>26 weeks25 mcg Vaginal Every 6 hours.OR25 mcg Oral Every 2 hours.
MEDICATION ABORTIONUse as permitted within the country’s legal framework.
RegimenMEDICATION ABORTION WITH MIFEPRISTONE AND MISOPROSTOLUp to 9 weeks gestationMifepristone 200 mg oral followed 24 to 48 hours later by misoprostol 800 mcg vaginal, sublingual or buccal. For oral route, 400 mcg misoprostol can be used up to 7 weeks of gestation.9-12 weeks gestationMifepristone 200 mg oral followed 36 to 48 hours later by misoprostol 800 mcg vagi-nal. Subsequent misoprostol 400 mcg vaginal or sublingual can be used every 3 hours until expulsion of the products of conception, up to 4 further doses.12-24 weeks gestationMifepristone 200 mg oral followed 36 to 48 hours later by misoprostol 800 mcg vaginal or 400 mcg oral. Subsequent misoprostol 400 mcg vaginal or sublingual can be used every 3 hours until expulsion of the products of conception, up to 4 further doses.Dose Route InstructionsMEDICATION ABORTION WITH MISOPROSTOL ONLYUp to 12 weeks gestation
800 mcg Vaginal or sublingual Every 3 hours, maximum 3 doses.
12-24 weeks gestation
400 mcg Vaginal or sublingual Every 3 hours, maximum 5 doses.
Figure 4: Misoprostol regimens pocket reference for clinicians
administer misoprostol for PPH prevention and treatment. The addition of misoprostol expands uterotonic coverage, especially to more rural women, reducing the risk of PPH. Ultimately, the burden on referral hospitals of providing PPH treatment to large numbers of women will be reduced. Most importantly, misoprostol can contribute to preventing the unnecessary loss of women’s lives from postpartum hemorrhage. Programmatic Recommendations 1. Integrate misoprostol as an
additional uterotonic for PPH management at all health facilities that conduct deliveries in Zimbabwe.
2. Ensure that rural health centers and rural hospitals can manage PPH in order to decrease costs, both to women and to the
health system, of managing complicated PPH cases at higher level facilities.
3. Disseminate and implement the BEmOC guidelines, to ensure that providers can correctly implement PPH management and referrals according to protocols.
4. Provide training and job aids on the use of misoprostol for PPH management, following the service delivery protocols, to all maternity service providers, including physicians, midwives, nurses, primary care nurses, and nurse aides.
5. Incorporate training on misoprostol for PPH management into the pre-‐service curricula of the medical, nursing, and midwifery schools.
6. Increase community awareness about the dangers of excessive blood loss at delivery,
recognizing excessive blood loss, and the importance of delivering in a health facility.
7. Register misoprostol for obstetric uses in Zimbabwe, as an important first step to ensure the ongoing supply of a high quality product.
8. Adopt and implement procedures for the ordering and distribution of misoprostol to ensure its availability for PPH management in all levels of health facilities, with special attention to ensuring stocks in rural facilities where the need is most often unmet.
9. Consider the integration of PPH prevention with misoprostol at the community level through appropriate interventions to ensure uterotonic coverage for all women giving birth.
Perspectives from providers: One Primary Care Nurse at Masasi Rural Health Center in Mutare District stated: “Misoprostol is useful in a rural setting. It cuts costs and it’s not refrigerated.” Another Primary Care Nurse from Chikwakwa Rural Health Center in Chimanimani District said: “Misoprostol was useful in our setting as we sometimes are short of oxytocin. Although we didn’t have [women who developed PPH] we feel that could have handled it well.”
A Midwife at Nyamazura Rural Health Center in Mutare District reported: “Misoprostol was easy to administer and no problems were encountered in using the drug. We recommend the use of it at areas like outreach points so as to assist the hard-to-reach clients.”
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