Global Health Council (GHC36): Magic bullets & usability for postpartum hemorrhaging
Posted by | Posted in Access to Health, Conferences, Design, Global Health, Health Systems, Human Resources, Infrastructure, Innovation, Maternal and Child Health, Medical Devices, Research | Posted on 29-05-2009
This will be my last post from the Global Health Council conference, but likely not the last from our team. This one is from a morning session I attended “Postpartum Hemorrhage: New Findings and Innovative Technologies” (session F4). From the conference website:
Presenters Discuss: possible risk factors for postpartum hemorrhage (PPH) and the impact of active management of the third stage of labor and its components on postpartum blood loss (Global: Egypt, Ecuador, Turkey, Burkina Faso and Turkey); a demonstration project to assess feasibility, acceptability, and safety of oxytocin in Uniject as a first step to introducing the device on a national scale, and strategies for scaling up use of oxytocin-Uniject™ devices with time-temperature indicator (TTI) for the prevention of PPH (Mali); techniques for estimating blood loss for the early and accurate diagnosis of PPH and cost-effective and reliable techniques for improved blood loss estimation in rural settings (India, Tanzania) and the importance of obstetric hemorrhage as a cause of maternal mortality and morbidity in low-resource settings, the potential contribution of the non-pneumatic anti-shock harment (NASG) to reducing death and disability from obstetric hemorrhage (Nigeria).
The session was moderated by Suellen Miller of UCSF – who works on NASG among other projects. The panelists, in order of presentation:
- Jill Durocher – Gynuity Health Projects, Determinants of Postpartum Hemorrhage [AMTSL]
- Stacie Geller, PhD – University of Illinois-Chicago, Accessible Techniques for Improved Estimation of Blood Loss [blood drape]
- Dosu Ojengbede – University College Hospital, Ibadan, Nigeria, Non-pneumatic Anti-shock Garment’s Potential for Obstetric Hemorrhage in Africa for Improved Estimation of Blood Loss [NASG]
- Susheela Engelbrecht, CNM – PATH, Implementation Challenges on a Larger Scale [Uniject+oxytocin]
If you think you don’t know enough about PPH, check out this wikipedia entry.
By this point in the conference, I’m sure I’ve exposed my biases- I’m interested in exploring themes across projects, with a particular emphasis on opportunities for innovation. This session was no different. Two key themes emerged: (1) these innovations are not magic bullets – larger supporting systems need to be in place for them to be effective, and (2) there are opportunities for improving outcomes by improving the usability of these products.
No magic bullets
Susheela Engelbrecht’s wording in reference to Uniject syringes preloaded with oxytocin was a bit different: “It is a magic bullet, but many other things need to be in place”. With the NASG, the technology buys critical time but is not a “definitive treatment” alone – it still requires patient monitoring, for which appropriate staffing and essential drugs are essential. The multi-country AMTSL (active management of the third stage of labor) study suggests that steps such as controlled cord contraction and fundal massage are only effective in the context of uterotonic drug administration.
Improving usability
The technological innovations presented all show significant promise. The Nigeria study, using a pre/post intervention design, showed a reduction in blood loss of 61% and a reduction in mortality of 60%. The morbidity numbers were too small to make any inferences. A randomized controlled trial showed that, compared to a gold standard measure, the blood drape (Geller) was 33% more accurate than visual estimation.
Uterotonic drugs were shown to play a critical role in AMTSL and the Uniject+oxytocin solution allows administration at the point-of-care to avoid many of the pitfalls associated with ampoule+oxytocin+syringe administration; however, there are some outstanding issues with cost and policy:
- cost: the Uniject solution will “always” be more expensive, currently a bit less than US$1 based on an Argentine formulation
- policy: at what levels of the health system should this be used? should it be used only for AMTSL or also for PPH?
As we begin to move toward scaling these technologies, it will be important to understand how people will use (and misuse) these technologies in environments that are not subject to the scrutiny of research studies.
Some notes I jotted down about usability innovations and challenges from the talks:
- The blood drape had the unanticipated benefit of keeping things clean (containing blood), from the perspectives of women, birth attendants, and families
- The original blood drape showed quantities (cc) of blood using a numerical scale, but a later version simply used a yellow line (alert) and red line (action) to identify risk level
- For the blood drape, the alert and action values were not based on WHO standards, which are designed for equipped, clinical settings, but were calibrated based on data from deliveries in rural India (e.g. WHO standard was 500cc for alert, and the value used with the blood drape was 350cc)
- Birth attendants and families using the blood drape for home deliveries on the floor came up with the idea of propping up the mother’s head with a dupatta to encourage the blood to flow into the drape
- The blood drape must be placed under the women after birth, so that it doesn’t accumulate amniotic fluid (this is after all postpartum hemorrhaging)
- With NASG the challenges include washing (decontaminating), drying, and folding – if this isn’t done in time, the benefit of the garment may be lost for the next patient – whether it is sent somewhere for decontamination or if it is done locally
- The Uniject+oxytocin solution requires more space in the cold chain since the syringe and packaging takes up more space than standard ampoules for the same volume
- With Uniject+oxytocin, some women though they were receiving a contraceptive injection against their will since their prior experience with pre-loaded syringes was with Depo-Provera
- “Training was a non-issue” with Uniject+oxytocin. Those who read the instructions felt as comfortable as those who were trained by demonstration.
During the Q&A there was one more. Professor Ojengbede mentioned a case where a woman wore the NASG for four days in order to wait for a blood transfusion. As soon as the bleeding stopped, she continued to wear the garment and walked around the ward. In response to a question about complications from wearing such a garment, the team indicated that there were no cases of deep vein thrombosis or pulmonary embolism. Note: the Nigeria study will soon be published in the Journal of Obstetrics and Gynecology.
