Colombia Experience

In Colombia, postpartum hemorrhage has been an essential problem of maternal mortality; the entity has raised public sector alarms for the development and implementation of programs that optimize its management. Cali is located in the department of Valle del Cauca; it is the reference city of the Colombian Southwest due to the high complexity of its hospitals; one of them is the Hospital Universitario Fundación Valle del Lili. In this region an Obstetric Critical Care Unit has been established as a center of care for patients with a high risk of mortality and extreme maternal morbidity. We receive patients from all regions of the country, especially from the hospitals to which we perform the intervention that will be explained later (16 hospitals)

According to the most recent statistics (2018), the department has three municipalities where maternal mortality exceeds the national maternal mortality ratio.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Given the statistics of maternal morbidity and mortality reported in the last two decades, in 2013, the Obstetrician group composed of 24 Obstetricians decided to implement the American model of PPH treatment and began using bundles for postpartum hemorrhage as an approach to reduce complications derived from excessive bleeding. Initially, there were master classes, simulation exercises to disseminate and systematize patient care standards among the medical and nursing group. In that year, the red code included non-pneumatic anti-shock garment, uterine balloon tamponade, uterotonics, and hemostatic agents such as tranexamic acid. In  addition to the international standard, rapid response teams in obstetrics, emergency transfusion packages, adequate equipment for obstetric emergency care were established. Bundles were well received in our hospital, but despite some positive results in indicators of maternal and perinatal morbidity and mortality, the treatment of postpartum hemorrhage was carried out differently depending on the Obstetrician on a particular shift.  For this reason, in the second period corresponding to 2017 until today (2020), we created checklists which allowed all obstetricians to adopt the same standard to avoid delays and complications during a red code. Following a red code, we initiated reporting systems and post-event learning meetings (debriefing). This strategy had a positive impact on maternal and perinatal outcomes such as decrease days in-hospital stay, number of transfusions, decrease in the rate of hysterectomies, etc.

Despite the benefits of the implementation, in Colombia, we did not have enough evidence to justify the use of the bundles. Due to the socio-economic conditions of our country, it was difficult to find necessary equipment and drugs (like the NASG) for the red code in primary and secondary hospitals.  So the group of obstetricians of Fundacion Valle del Lili decided to write a paper to demonstrate the effectiveness.  We compared PPH patients from the period from 2011 to 2013 (77 patients) who received standard management without a non-pneumatic anti-shock garment (NASG) and (77 patients) 2014 to 2015 who received standard PPH management plus NASG. The results obtained were the following: the leading causes of PPH were uterine atony (96.1%), placental retention (9.7%), abruption of the placenta (6.5%), and placenta previa (4.5%). All patients in the first period showed shock rates higher than 1 which was directly related to hemodynamic instability secondary to hypovolemia, 89% of cases required massive transfusion.

The results showed that the need for blood products was statistically significant WHEN COMPARING THE 89% in the non-NASG group tO 39%and the NASG group, Abdominal hysterectomy was more common in the non-NASG group compared to the NASG group (98.2% versus 1.8%). In conclusion the use of NASG in critically ill patients demonstrated a speedy recovery from hypoperfusion, in addition to the prevention of the use of invasive procedures that produces an increase in maternal morbidity and an increase in costs.

These results allowed the Obstetrics team to make visits and to record which hospitals had all the necessary tools for the full practice of the red code. During the visits, some hospitals had the NASG, but staff did not know the technique and the right time to use it.  In other cases, they did not have the NASG because it “represented a high cost” for the hospital (230.00 US) These findings stimulated staff and administration to seek funding and develop an action plan that would improve the care of obstetric patients and diminished mortality.

So, in 2017 with the Health Secretary of the district of Valle del Cauca, the group of Obstetricians began the training and on-site simulations in 5 nearby hospitals of Primary, Secondary and Tertiary care. Additionally, it was possible to carry out multiple simulation practices in our institution with collaboration   from the remaining hospitals of Cali. Due to the positive feedback, Dr. María Fernanda Escobar initiated a Telemedicine strategy as a project leader for implementing the bundles in a red code for referring hospitals.

In August 2018, the project was extended to all the North of Cauca department, where maternal mortality far exceeded the national average.  As of Dec 31 2019 the results show a major reduction of maternal mortality in the intervention area. These results present a challenge to expand open telemedicine to other regions of Colombia. As of January 2020 the group received more than one hundred tele-consults.

Now, when comparing pre and post-intervention statistics at the national level, it is observed how maternal mortality has been declining. (Table 1 and 2). These results provide hope and motivation to continue our magnificent work of improving the quality of care of obstetric patients.??? using bundles, red code and standard check lists for PPH diagnosis and treatment…

 

Table 1

Maternal mortality notification

Colombia, weeks 01-50, 2015 – 2017

Year Early Late Coincident Total
2015 330 99 43 472
2016 306 124 36 468
2017 328 109 35 472

 

Table 2

Maternal mortality notification

Colombia, weeks 01-23, 2017 – 2019

Year Early Late Coincident Total
2017 163 63 21 247
2018 110 71 44 225
2019 145 43 22 210

 

On-site master seminars
Simulation scenario – necessary implements for red code attention

 

 

 

 

 

 

 

 

Simulation scenario: necessary implements for red code attention
Clinical simulation: Red code attention

Country Experiences: Niger

Why try a standardized approach to PPH Treatment in Niger?

To save lives, prevent suffering, and save money for the inhabitants.[i]

Niger’s Ministry of Health launched its Initiative to Prevent Women from Bleeding to Death at Childbirth using proven, low-tech, low-cost, new technologies combined in an innovative way because, if nothing is done, roughly 10% of women the world over bleed severely, and up to 18% bleed enough at childbirth to meet the criterion for PPH.1,[ii],[iii] Also, in most settings, PPH is the main cause of maternal mortality.[iv]

Prevention in a hot climate without reliable refrigeration uses misoprostol costing < $1 USD, immediately after birth. This reduces the occurrence of excessive bleeding by over 70%.[v]

3-Step Treatment is given to those who bleed too much anyway (≥500 ml.), as is seen when a traditionally used cloth becomes soaked with blood. The 3-Step Treatment is:

1) Give the woman a treatment-dose (800 mcg) of misoprostol.  If the bleeding does not stop within 25 minutes, then proceed to step 2.

2) Place a Condom Tamponade – a condom tied onto a catheter, inserted into the bleeding uterus – and inflate with 300-500 ml of water. If that does not stop the bleeding within 6-12 minutes, proceed to step 3.

3) Apply a non-pneumatic anti-shock garment (NASG) and get her directly to surgery at a pre-defined “definitive treatment hospital” where an obstetrician is available to do specialized procedures such as B-Lynch sutures, artery ligation, etc, even if far away.   Note: Antibiotics are in each tamponade kit to protect against infection because we insert clean but unsterile equipment into her uterus.

At their 3rd trimester prenatal consultation, each woman gets a prevention dose of misoprostol with instructions on when and how to use it, given in case she does not make it to the health center in time. However, she is encouraged to give birth in a health setting and bring the dose with her.

This 3-Step Treatment is by health workers, who receive training and supplies.

Niger is the first country in the world to take such ambitious steps aiming to halve PPH mortality nationwide. This cost about $700,000 to put in place nationwide for a population of 17.8 million in 2014, including the baseline survey. Cash benefits for the population are roughly estimated to be on the order of 12 times greater than the annual cost. This includes benefits from deaths averted, and loss of income from severe anemia in PPH survivors, using half of WHO’s 6-month Burden of Diseases estimate for the duration of income-loss from severe anemia. We used $1/day as the estimated income for the population of Niger.

What counts most is, of course, people’s lives. The women themselves and children who can have their mother survive to be with them as they grow up! Averted loss is also nice.

Can a standardized approach to PPH Prevention and Treatment succeed in Niger, a country at the bottom of the UN’s Human Development Index? [vi]

Niger’s standardized approach to PPH Treatment (and Prevention) has been published, together with its scientific basis. Analysis of its impact is in the process of being published in a peer-reviewed medical article, as must be done if one is to have scientific credibility.

Meanwhile, here are a couple of anecdotes.

PLEASE NOTE: A story or two does not constitute scientific evidence by any means! And these anecdotes do not constitute “publication” of whether Niger’s standardized approach to PPH Treatment is working, or not.

The waking of a doctor

Shortly after the country started putting in place its PPH Prevention and Treatment Initiative, the medical director for one of Niger’s eight regions called the capital to “complain.” Why? He had been woken by his telephone at 5 in the morning – not a typical experience for upper-level administrators in any country’s health system!

A doctor in his region was so excited by the following experience that he could not resist phoning his boss to share the good news: At 02:00 in the night, a woman gave birth at his health center and began bleeding furiously. By chance, just a few days earlier he had been trained but was (wrongly) not given necessary supplies for the new PPH Initiative.

Remembering his training, he dug around to find a condom somewhere. He found some string, a catheter, and a large syringe. He tied the condom to the catheter, inserted it into the woman’s uterus, inflated the condom with water through the catheter as he had practiced on a simulator just a few days before. The bleeding stopped almost immediately!

The midwife’s uterus

A midwife was herself giving birth to her first child, at the hospital where she works. All went well with the mother and child until the baby was born. Then she started to bleed. Massively. The maternity staff and the on-duty doctor rushed her toward the operating theater, where he intended to do a hysterectomy to save her life.

Problem: arriving, they discovered the operating theatre was busy! Somebody was already on the table, undergoing surgery.

In desperation, hoping to keep her alive until the surgery became freed-up, the doctor who had recently been trained in Niger’s standardized approach to PPH Treatment inserted a Condom-Tamponade, right there in the hallway. The bleeding stopped. Her life and her uterus, both were saved that night!

 

 

 

 

Copyright Credit:   Grandmother with twins. © Dr. Zeidou Alassoum

Copyright Credit:   Fig. 1 and Fig. 2 are from Seim AR, Alassoum Z, Lalonde AB, Souley I. An Integrating Model for Rapid Reduction of Maternal Mortality Due to Primary Postpartum Haemorrhage – Novel Use of the Catalyst Approach to Public Health. Afr J Reprod Health 2019; 23[2]: 18-26. DOI: 10.29063/ajrh2019/v23i2.2

[i] Seim AR, Alassoum Z, Lalonde AB, Souley I. An Integrating Model for Rapid Reduction of Maternal Mortality Due to Primary Postpartum Haemorrhage – Novel Use of the Catalyst Approach to Public Health. Afr J Reprod Health 2019; 23[2]: 18-26. DOI: 10.29063/ajrh2019/v23i2.2

[ii] AbouZahr C. Global burden of maternal death and disability. Br Med Bull. 2003: 67: 1-11.

[iii] El-Rafaey H, Rodeck C. Post-partum hemorrhage: definitions, medical and surgical management. A time for a change. Br Med Bull. 2003; 67: 205-17.

[iv] World Health Organization. Trends in maternal mortality: 1990 to 2015 estimates by WHO, UNICEF, UNFPA, World Bank Group, and the United Nations Population Division. Geneva: WHO; 2015. 93 p.

[v] Bellad MB, Tara D, Ganachari MS, Mallapur MD, Goudar SS, Kodkany BS, et al. “Prevention of postpartum hemorrhage with sublingual misoprostol or oxytocin: a double‐blind randomized controlled trial.” BJOG. 2012; 119.8: 975-86. doi:10.1111/j.1471-0528.2012.03341.x

[vi] UNDP. Human Development Report 2019. See p. 303.

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

Country Experiences: India

The Work In India Begins

Postpartum hemorrhage is still the major maternal killer in India.

Most of the time the mother cannot be saved because of the various delays in seeking the appropriate healthcare. In spite of many government programs, training and workshops the problem still exists.

The project “Management of PPH using Bundle approach, a comprehensive approach using non-clinical and clinical components together with special reference to ESM UBT and NASG,” was planned in 11 medical colleges all over India from Maharashtra and Madhya Pradesh. The project was planned and drafted in collaboration with MGH, Harvard under the leadership of Dr. Thomas Burke, the Chief of Global Health Division. MGIMS Ethical committee approval was taken. Then permission was obtained from the Government of Maharashtra and the project was implemented in all the sites.

 

The project was planned in two phases. Phase one used a clinical component with special reference to see the acceptability, efficacy, and feasibility of the Every Second Matters – Uterine Balloon Tamponade (ESM-UBT). Phase two was implementing the non-clinical component and seeing its impact.

In phase one, all principal investigators were trained in MGIMS Sevagram with MGH trainers on the clinical components and the skills needed for implementation of the clinical bundle. These master trainers then developed their own team and trained them in a similar way. Each one implemented a full clinical component of the bundle at their own settings in different facilities selected by them. The non-pneumatic shock garment (NASG) was added in the bundle 7 months later.

In phase two, the medical colleges took up one component of a non-clinical component of the bundle. The components chosen were: system integration, facility readiness, team approach, emergency response team configuration, quality improvement, advocacy, and branding.

The Wardha District with two medical colleges and district hospitals took up the system integration, which of course had a subcomponent of facility readiness and team approach in emergency situations. The district has the following geography (see below) and the district authorities gave immense cooperation to implement this project at all health facilities.

The official orders were placed for the training of these facilities and their follow-ups by district authorities and the program was planned.

 

Implementing The Bundle

The components of the bundle were implemented in these health facilities up to PHCs with a structured plan. The bundle approach, with its technical and nontechnical components, was developed as a package. The first workshop was conducted in the Department of OBGY at MGIMS Sevagram, Wardha.

The additional 10 medical colleges were there along with their colleagues and nearly 28 obstetricians attended the training on January 10th, 2017. The project started by following a comprehensive clinical approach for the management of PPH and use ESM-UBT for seeing its efficacy, feasibility, and acceptability. 

Seven months later, a component of NASG was added and a refractory response for management of PPH,  which did not respond to preliminary treatment, was planned. In Sep 2017 the bundle approach was implemented once all the PIs were well-versed with the clinical protocol and retraining were done using lectures, skill stations, videos and focus group discussions. Several follow up meetings were done and the PIs presented their learning in the form of benefits and challenges. Based on that the project was modified and re-implemented.

Follow up meetings with MGH team were held on:

  • April 24th, 2017  
  • November 3rd, 2017
  • April 3rd & 4th 2018
  • June 22nd, 2018
  • September 28th and 29th 2018

In each meeting intense discussions were there, the success stories were told, the failures and their reasons were discussed, and interesting cases were discussed in detail. Some very interesting cases came up. Beyond this, several phone calls were done to the trained staff to ensure their work and quality project implementation.

The Wardha district took over the clinical and non-clinical components of system integration for the management of PPH using the bundle approach and to see its impact over the PPH death, case fatality, MNM, and MDR.

India’s National Context For PPH Management

After many verbal autopsies, it was observed that in many cases — particularly from distant rural areas — it is the time which is crucial in the management of PPH.

The women do not reach facilities on time, there is no communication, and the facilities are not ready for critical care management. To address these issues, team leaders took up a project in association with MGH, Harvard University with Dr. Thomas Burke, Chief of Global Health and Human Rights, MGH, Harvard, USA as principal investigator.

11 medical colleges over Maharashtra and Madhya Pradesh were selected who gave their commitment to the study. Evidence-based protocols were used as recommended by the Government of India (GOI) and the Federation of Obstetric and Gynaecological Societies of India (FOGSI). Tranexamic acid (TXA) was given once or twice to all PPH women. The ESM-UBT was inserted in all women with refractory PPH and it was noted that insertion of ESM-UBT did change the scenario. A number of women with grade 3 and 4 shock could be saved. During the process, it was realized that delayed referrals with no appropriate referral protocols and facility readiness were the main issues for PPH deaths.

After mapping the Wardha district, it was realized that there was a great need for vertical integration. The vertical integration project was taken up by the department of OBGYN, MGIMS Sevagram and JNMC Sawangi for training all the facilities in the management of PPH using the universal protocol. Eventually, in the catchment areas of the 11 medical colleges, 23 PHCs and 21 CHCs were covered by this PPH effort in addition to all the facilities in the original Wardha district.

The approach used was for PPH, which is a national public health issue and a top priority in Maternal Health. The nation aims at zero preventable deaths and PPH management using bundle can help us reach the national goal.

 

The National Health System Behind The Work

There are GOI and FOGSI guidelines for the comprehensive management of PPH. We modified it and implemented that with GOI permission. The results were communicated to the central government and the project was put under the national portal of innovation and in 11 countries partner’s forum. HLL, a GOI company, was asked to make the ESM-UBT kits.

Successes & Enabling Factors

PHASE I

  • All the faculty and staff became aware of evidence-based  comprehensive and universal  clinical protocol of PPH management
  • TXA treatment was re-enforced as routine treatment for all cases of PPH
  • All the faculty and staff became skilled in ESM-UBT and NASG application
  • The number of dying mothers due to PPH could be saved
  • There was a significant reduction in the surgical management of PPH and many women uterus were saved
  • The number of blood transfusions reduced significantly
  • In-house team spirit and enthusiasm lead to horizontal integration
  • The training was extremely useful the whole team was well versed in the management protocol

PHASE 2

  • Team exposure to the community increased 
  • The overwhelming response of the community was positive
  • Enhancing confidence of lower health facility staff with support through a helpline, facility readiness, etc
  • Good implementation of GOI programs
  • Will to change for learning good practices was noticed and there was a changing attitude of doctors and nurses
  • Mannequin teaching – skill stations were a very useful tool for training
  • Charts help better than PPT in training the staff
  • ADULT RESUSCITATION station and UBT with NASG station were very useful, and the staff practiced frequently
  • Workshop continuing beyond the timings as we decided to reach them personally and train them
  • The enthusiasm of staff in learning skills was worth seeing
  • The ideal referral protocol was consistently followed thereafter

Reviewing The Results

The results of the bundled approach showed great improvement in the medical care given to women experiencing PPH. Here are some of the key takeaways:

  • In 322 women clinical bundle was implemented
  • 81% were in grade 3 and 4 shock
  • Average time to control the bleeding after using ESM-UBT was 23 minutes
  • Average water used to inflate ESM-UBT was 480 ml
  • Average time for removal of ESM-UBT was 21 hour
  • Spontaneous expulsion was seen in 6 cases but in all these bleeding stopped and uterus contracted to push out the balloon
  • The 9 deaths were of the cases which were already either in DIC, Jaundice and in renal failure
  • On comparing the data with historical data of the last 3 years prior interventions it was seen that there was 56.8% reduction in PPH deaths with significantly reduced morbidities
  • Significant reduction in cesarean hysterectomy and number of blood transfusion was seen

In conclusion, the PPH Bundle Card is the best approach for the clinical management of PPH. In addition to the bundle, some important non-clinical components which can reduce PPH morbidity include strong system integration, facility readiness, cohesive team approach, and emergency response team configuration. Effective training of faculty and staff on the newer modalities of PPH treatment are additional keys to success.