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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.

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.