Statement on uterine balloon tamponade in post partum haemorrhage

Postpartum haemorrhage (PPH) remains the most common cause of maternal death worldwide. Uterine balloon tamponade (UBT) is a simple, inexpensive and readily available method used to treat this.

Suarez et al [1] carried out a systematic review and meta-analysis in January 2020, in which the authors analysed all ninety one eligible studies and found the highest success rates corresponded to uterine atony (87.1%), as opposed to morbidly adherent placental disease, or retained products (66.7 and 76.8% respectively). The frequency of complications attributed to UBT use was low (≤6.5%).

There are conflicting data, with some experimental studies suggesting no beneficial effect, but overall, the authors conclude that UBT has a high success rate for treating PPH and appears to be safe; also acknowledging that further research is needed to determine the most effective programmatic and health care delivery strategies on the introduction and use of UBT.

These findings were corroborated in a study by Adegoke et al, which looked at the use of UBT in Tanzania [2]. This study concluded that ease of use and the prospect of saving life and preserving fertility strongly promoted its use, whilst fear and lack of high-level buy-in hindered utilisation of the UBT.

While these data are not entirely consistent, UBT does appear to be a safe and effective way to reduce PPH, especially in the atonic uterus, which is the most common cause of PPH.
We welcome further work to add to these data, and to further explore how to effectively introduce UBT as part of a care bundle, in our collective efforts to tackle PPH, the leading cause of maternal death globally.

1. Suarez, S., et al., Uterine balloon tamponade for the treatment of postpartum hemorrhage: a systematic review and meta-analysis. Am J Obstet Gynecol, 2020.

2. Adegoke, O., et al., A condom uterine balloon device among referral facilities in Dar Es Salaam: an assessment of perceptions, barriers and facilitators one year after implementation. BMC Pregnancy Childbirth, 2020. 20(1): p. 34.

Country Experiences: Nigeria

The Network Of Care Is Formed

*Images, captions, and additional case study data provided by the Clinton Health Access Initiative (CHAI) website.

In 2014, the Nigerian government partnered with the Norwegian Agency for Development Cooperation (Norad) and the Clinton Health Access Initiative, Inc. (CHAI) to reduce mother, newborn, and stillbirth mortality across regions of the country with the highest incidences of these deaths.

The resulting program, an integrated approach to maternal and neonatal care that focused on averting preventable deaths that occur in the 48-hour window around delivery, achieved dramatic reductions in mortality rates within 18 months of implementation in Northern Nigeria.

The program was implemented, in partnership with state governments, in 30 districts across the states of Kaduna, Kano, and Katsina, which have a combined population of 10 million. It addressed critical gaps in care by integrating the entire health system, from the home — where over 80 percent of births in the region occur — to the primary health center, to the hospital, thereby building a network of care.

The Network of Care’s Core Elements

  1. Defined Roles and Responsibilities

Approach: Clear protocols were established across each level of the health system, depending on the level of skill and cadre of birth attendants available, to address the major mortality drivers that lead to poor outcomes. Referral protocols were developed and finalized for all levels, clarifying the roles of the frontline providers to identify, manage, and/or refer obstetric and newborn emergencies.

Application: CHAI worked with the Federal Ministry of Health (MoH) and state governments to develop clear protocols covering both the proper mentoring curricula for birth attendants and serving as a basis for an effectively operated vertically integrated system clearly articulating individual roles and responsibilities. Understanding how everyone fits within the wider supportive system cultivated a broader sense of accountability.

  1. Referrals

Approach: A comprehensive referral system was introduced, building on existing emergency transport networks. The system extended from the community to the hospital to identify and monitor symptoms of pregnancy complications, enable emergency transportation when needed, and facilitate feedback sharing between health workers. High-risk pregnancies in particular were identified and closely tracked, with clinical birth plans prepared to include transport to the nearest suitable facility in advance of or at the onset of delivery.

Application: Community Health Workers (CHWs) were trained to conduct home visits to pregnant women in more remote locations who may not have attended, or had stopped attending, antenatal care (ANC) appointments at local health centers. The CHW would encourage the women to attend ANC and to give birth at the center so pregnancies that would otherwise have been missed were monitored. A feedback mechanism developed, allowing any complications that arose to later be evaluated and learnings discussed.

This effort was underscored through the establishment of an emergency referral network of focal persons, health facilities, and emergency transport drivers. Referral pathways and directories containing emergency contact details of all health facilities and drivers were developed and printed. This approach also involved the expansion of the voluntary public transport driver scheme and the introduction of Motorbike Ambulances (MBAs) to serve more remote areas.

Drivers and CHWs received mobile phones for communication using a Closed User Group (CUG) network. While drivers were not paid a stipend, they received ongoing motivation and support through quarterly supportive supervision meetings held to discuss issues, receive recognition for performance, and develop a better sense of ownership. The emergency referral system, in addition to the enhanced monitoring protocols and introduction of misoprostol and NASG at the community level, enhanced the effectiveness of the network of care by expanding the ability of CHWs and other community members to identify and respond to complications of pregnancy and childbirth as early as possible.

Most importantly, it enabled CHWs to stabilize patients and increase their chances of survival during referral transportation.

  1. Mentoring 

Approach: A clinical mentoring program was established to train skilled birth attendants in birth protocols, including Postpartum Hemorrhage (PPH) control, with a focus on clinical competencies. Rather than conventional classroom-based, didactic training, this program used a clinical mentoring approach with multiple interactions between an expert, experienced clinical mentor and the frontline health workers over an extended period of time (up to 6 months).

This approach ensured effective task shifting capacity for the majority of the frontline providers, operating as a cadre lower than nurses and midwives in the health facilities. By linking CHWs to the health facilities for ongoing clinical supervision and mentoring, the program established strong relationships between birth attendants operating at each level of the health system.

Application: A competency-based, cascading mentoring model was utilized premised on ‘learning by doing” and including a significant PPH control component. The model was primarily focused on building the capacity of health care and community health workers who come in contact with the majority of the births and obstetric/newborn complications.

The mentoring model was split into a two-tiered system: clinical mentoring and community mentoring. At the PHC level, experienced clinical mentors were recruited and trained to mentor a pool of frontline health workers. These workers were, in turn, able to support community-level mentoring, supporting the linkage of community birth attendants to PHCs.

  1. Equip and Supply

Approach: Procurement and supply chain processes were strengthened, with key commodity gaps filled as necessary. CHAI supported the state and local governments to ensure that critical medicines and supplies were consistently available following the end of the program. The maternal and neonatal health services, particularly PPH control, that the program provided cannot be sustained without ensuring that essential, cheap, life-saving commodities and equipment are consistently available.

Application: CHAI conducted a rapid inventory assessment to determine the current availability of commodities in the State Central Medical Stores. Based on this, CHAI helped develop a rapid two-year forecast to inform program implementation across the three states. This, in turn, informed the statewide planning, procurement, supply plan, and logistics systems.

CHAI further helped ensure the availability of sufficient quantities of commodities at facilities by reinforcing the supply chain from the state stores, supporting review and resupply meetings and bridging commodity gaps. Key innovations related to equipment and supply were the addition of misoprostol for use in the community, and introducing NASG into the network of care to stabilize women in hypovolemic shock as definitive treatment is sought. Some additional equipment required to address other key birth complications, such as neonatal resuscitation devices, was also provided.

  1. Reliable Data Systems

Approach: A sustainable data system was developed to keep track of all birth and death events and sharing results throughout all levels of the health system. This was done not only to ensure oversight of the integrated system but also to facilitate wider levels of accountability. A Community-Based Management Information System (CBMIS) was designed to support the existing facility-based reporting that is captured through the Health Management Information System (HMIS). The CBMIS built upon an already existing, but largely dormant, traditional system for documenting births and deaths that relied on traditional leaders to locate and report a live or stillbirth and maternal or neonatal death.

Application: The CBMIS was able to collect all live births and birth-related deaths that occurred across CHAI’s focus geographies, not just occurring in the health facility. It also showed monthly trends on reported events in the community which informed the effectiveness of the integrated approach to reduce maternal mortality.

Nigeria At A National Level

PPH is the leading cause of maternal death in Nigeria and accounts for almost 25 percent of maternal deaths in the country. Of all women who die during childbirth globally, 19 percent are Nigerian; in fact, the country accounts for the largest number of maternal and neonatal deaths and stillbirths worldwide. The highest mortality rates in Nigeria occur in the impoverished Northern region, an area marked by poor access to health care and major challenges toward improving healthcare and reducing mortality.

Most of these deaths are preventable, with the majority caused by a small number of treatable conditions. The three leading causes of maternal mortality, which account for more than half of all maternal deaths, are hemorrhage, sepsis, and eclampsia. The conditions resulting in 80 percent of all neonatal mortality include preterm birth complications, birth asphyxia, and neonatal infections.

PPH prevention and management is a national priority. While a policy for use of misoprostol at the community level was introduced in 2011, implementation had been uneven, perhaps due to lack of functional networks of care, and limited state-level operational evidence regarding its implementation. Nigeria updated its guidelines for the prevention of PPH and included NASG as one of the interventions, but prior to the CHAI program in the three states, the application of NASG in the country was limited.

 

Sample of a logbook used by volunteer drivers and Motorbike Ambulance riders as part of the referral system set up by CHAI.

CHAI’s Strategy At The National Level

Beginning in July 2014 CHAI, working with the MoH, initiated a program informed by this strategy and funded by the Norwegian Ministry of Foreign Affairs to reduce maternal and newborn mortality in Nigeria, focusing on the northern states of Kaduna, Kano, and Katsina, which together contributed 20 percent of the total maternal and neonatal mortality in the country.

Across the three states, 81 percent of women deliver at home, according to Nigeria DHS data. The program covers 30 Local Government Areas (LGAs), which have a total population of approximately 10 million people.

The primary objective of the MNH program is to accelerate progress toward reducing maternal and neonatal deaths by addressing critical gaps and creating linkages through the entire health system – from the community level to primary healthcare facilities to the hospital. The comprehensive approach focuses on averting the preventable deaths that can occur in the 24-48 hour window around the birth process through early identification of complications, prompt and effective clinical management of delivery, and when necessary, timely referral to more robust, fully-prepared treatment centers.

In particular, CHAI assisted the state governments to undertake six main activities to work toward a comprehensive approach to reducing mortality associated with childbirth:

  1. Clear protocols were established about what to do in each birth setting to address potential complications that can lead to mortality or poor outcomes.
  2. Skilled birth attendants were deployed to be available during all births and a hands-on mentoring system was established to train skilled birth attendants in these protocols.
  3. Procurement and supply chain systems were strengthened to ensure the reliable delivery of all the tools and drugs necessary to the skilled birth attendants to diagnose and treat these conditions when they arise according to the protocols.
  4. A referral system was established so that communications and transportation are available for those cases where women must be transferred to hospitals and health centers to be treated.
  5. Hospitals were equipped with blood banks and emergency response equipment and nurses and doctors at those hospitals were properly trained so that women who are referred can be properly treated.
  6. A management system was set up to establish and update the protocols, keep track of all births and to oversee the mentoring, supply chain, and referral systems necessary for the comprehensive approach to work.

To ensure community acceptance, buy-in, and ownership of the program, CHAI and partners implemented a community program and reactivated the CBMIS.

Photograph taken with emergency transport system drivers, FMOH, and CHAI staff during a visit by Norwegian representative to the field, Katsina State.

 

Challenges Faced By The Network

While agreeing upon the approach to building this network of care, initially government partners resisted providing clinical skills and commodities to traditional birth attendants participating in the network, as state policy seemed to discourage this. Reticence quickly eroded as the roles and responsibilities of workers at each level, including those responding first in the community, were made clear.

One of the more fragile aspects of the network of care has been to ensure that the operation of the transport fleet is sustained, allowing for reliable access to emergency transportation. Fuel and vehicle maintenance are key areas of concern and CHAI has worked closely with communities to secure local levels of support and continued funding.

Reviewing The Results

Key factors related to the enabling of the network of care and underpinning its success are the central participation of the community the network of care was built to serve, as well as the government health managers and workers.

No forms of monetary incentives were used to support this project, with non-monetary alternatives identified and utilized instead to ensure participants were recognized and encouraged.

This approach enabled the state governments to increase interactions at all levels through the formal health system, creating a continuum of care which stretched from the most rural village to the tertiary hospital, promoting trust, ownership, and communication. The impact of this program was significant, with maternal and newborn deaths, as well as stillbirths, dramatically declining across the three states. After analyzing data based on 185,509 records (live and stillbirths) for mortality and based on a conservative baseline, two independent, external evaluations, concluded that between the program period from July 2015 to June 2016:

  1. Substantial and sustained reductions in maternal mortality (37 percent), neonatal mortality (43 percent), and stillbirths (15 percent) had been produced;
  2. The declines are biologically plausible;
  3. The declines are comparable to those achieved globally in the previous 15-20 years, but were achieved in 12-18 months;
  4. There is no previous history of similar declines in the country.

The federal government of Nigeria is now scaling up key program elements across other states and is also encouraging other partners to adopt a similar strategic approach. This model has also been introduced in other countries, with similar integrated projects commencing in Ethiopia, Uganda, and Zambia.

Conclusion: The Network of Care Approach Saves Lives

We propose the network of care approach to significantly reduce PPH mortality across low-resource settings. This case study illustrates the implementation of a strategic, locally-adapted process that includes systematic interaction between maternal health care staff at various tiers of the system.

Successful implementation in Northern Nigeria required collaboration, trust, and teamwork. This was achieved through a participatory design process involving stakeholders across at least three levels (referral hospital, PHC, community), clear definition of roles and responsibilities, mentoring support and reinforcement, a common reporting system, improved supply chain, and involvement of all levels in follow-up and troubleshooting. Instead of merely a “referral system,” a district-based learning system based on vertical integration was developed at each site.

The promising results can be seen as multi-factorial and the lack of randomization procedures or stepped-wedge approaches could be argued to limit the strength of any cause-effect relationship. On the other hand, this was a locally developed set of real-world experiences that were not primarily designed for research purposes and instead represented a dynamic, ongoing search for a local solution that has since been largely adopted by the federal and state governments.

In Nigeria, joint principles were agreed across each level, including protocols, monitoring, and troubleshooting, with external support provided as needed by the MoH, local government partners, and development partners. This may sound simple but appears to often be more the exception than the rule. Many staff in health facilities across the world focus on saving the sick patient that comes through the facility door and are not enabled to address how staff at other facilities and communities can work in partnership together.

As the case study illustrates, the essential components of the network of care approach provide for systematic interaction between staff at different facilities, from hospitals to primary health centers and down to the community workers. Consequently, through this effort, a significant number of maternal and perinatal deaths were averted. The network of care approach may potentially be very important for various health system-dependent public health challenges and further application should be explored through systematic introduction in different environments and contexts and underscored by operations research.

Advancing Survival in Nigeria: A Pre-post Evaluation of an Integrated Maternal and Neonatal Health Program. Sloan NLStorey AFasawe O et al. .Matern Child Health J. 2018 Jul;22(7):986-997