We are a nonprofit committed to improving women’s health in developing countries by creating access to effective and affordable technologies on a large scale.Our model is to invest in creating access to interventions that are low-cost, relatively simple to use, and address a major burden of disease for women in developing countries. Our flagship program is around the generic drug misoprostol.Miso ops research on miso for PPH, PAC or MA in 9 countries, totaling approx 140,000 beneficiaries. I’ll share some highlights from Tanzania
Misoprostol comes as a heat-stable tablet.Three misoprostol tablets, when taken immediately after childbirth, help stop bleeding.Excessive bleeding after childbirth, or postpartum hemorrhage, accounts for 25% of maternal deaths globally and up to 34% in sub-Saharan Africa.99% of these deaths occur in developing countries, where women most often give birth at home, far from a health facility or skilled provider.Any woman can take misoprostol to prevent PPH. The tablets are taken orally and side effects are manageable at the household, making misoprostol an ideal public health intervention to take to scale.
WHO added misoprostol to its Model List of Essential Medicines for “for management of incomplete abortion and miscarriage and for prevention ofpost‐partum haemorrhage where oxytocin is not available or cannot be used safety
What does it take to create access to a product like misoprostol?When we started this program in 2004, it was used widely in the US and Europe under the brand name Cytotec.But it was largely unavailable throughout SSA and SA, the places where the rates of home births and PPH, and hence the need for the drug are the highest.There were approximately 127,000 deaths/year from PPH (WHO, 2000)When available, it was through small quantities imported for a short-term project or purchased on the black market. It was often costly and of uncertain quality.It was registered for stomach ulcers, which was its original use, but such a registration usually didn’t allow for it to be used legally for obstetrics.There was solid research in clinical settings and years of use in western hospitals, but little operations research to show how to deploy it in a rural developing country environment.
In six years, the map has changed dramatically… 16 countries have at least one misoprostol product registered for PPH on the market. All of our work is South-South trade, using local distributors and manufacturers from developing countries. There is momentum and each year, more and more countries are approving misoprostol for obstetric & gynecological use. Registration is the crucial first step, but it is just the first step.
Another important piece to this puzzle is the role of governments in establishing policies that support a new intervention.By including misoprostol in national guidelines for mid- and lower-level providers, Ministries of Health can open up access to far more of its population than through hospitals and clinics alone. Governments require scientific evidence of an intervention in order to approve this, which is why we have done operations research or pilot projects in 9 countries. OR in Nigeria coupled with policy advocacy lead to the development and dissemination of the world’s first guidelines for community use of miso for prevention of PPH!!Adding misoprostol to national essential medicines lists often establishes it to be duty-free, or procured through the government purchasing system.Through our work, we have assisted seven countries in updating local policies.Establishing policies around a new intervention not only establishes its reach but makes its use institutionalized, which means that it will be a part of the system even if governments or individuals change.
ANC attendance is high (94% at least one visit); home delivery is also high (53%); caveat – I helped design the research and oversaw its implementation; detailed questions re data analysis & results should be directed to VSI
For this preliminary report, we limited the analysis to include only those women who enrolled between March 1 and August 31, 2009, and who had an expected date of delivery before September 1, 2009. We therefore analyzed the Misoprostol Addendum information of 4,829 participants, over a quarter of whom had completed a postpartum interview (n=1,316; 27%).Postpartum interview data was only available for 27% of enrolled participants at the time of the analysis. Interview collection started a little behind schedule, and some enrolled women had not yet passed their EDD. Therefore, while currently the proportion of women who have participated in a postpartum interview is low, we expect to follow-up with the majority of participants by the end of the project for the final report. Postpartum interviews are ongoing, and in fact many have been conducted since this report was written.Participants attended an average of slightly fewer than three ANC visits over the course of their pregnancy (2.9). Overall almost two thirds of women delivered in a health facility (61%), which is slightly higher the national average of 47% in the most recent Demographic and Health Survey (National Bureau of Statistics (NBS) [Tanzania] and ORC Macro 2005). There was some variation in the rate of health facility delivery between districts, with Rufiji reporting the lowest rate of facility birth (55%) and Kilombero reporting the highest (72%).Correspondingly, approximately two thirds of women delivered with a skilled provider, most often a nurse-midwife (51%). However, there is a missing response on attendant at delivery for 515 participants, 507 of whom delivered either at home or on the way to the health facility, where it is presumable that she delivered with an unskilled provider (e.g. TBA, friend, relative, or alone).
Goal – protect women at home births from PPH. Many distribution mechanisms possible; some countries using community workers to educate AND distributeRationale for ANC in TZ:94% of women attend at least one antenatal care visit (ANC) during their pregnancy53% of women deliver outside of facilities
A “protected birth” is a delivery where the mother is protected from PPH by use of any uterotonic administered or taken for PPH prevention. Of those who participated in the postpartum interview, use of any uterotonic after delivery was quite high at 91%. Slightly more than half of these protected births were at a health facility, with either an injection (41%) or misoprostol (23%). Misoprostol at home deliveries “protected” an additional 27% of deliveries that occurred at home, and would not have been protected without misoprostol distribution at ANC. 91% of all home births in follow-up were protected by miso.
Of women who used misoprostol at home births, all who responded to the questions regarding dose and route reported using the correct dose and route of misoprostol. Therefore, correct misoprostol use was universal for all participants who used the drug at a home delivery for PPH prevention and answered the questions.
Acceptability of misoprostol was high amongst users and non-users alike. Almost all women would recommend misoprostol to a friend (98%), use misoprostol in a subsequent pregnancy (97%), or purchase misoprostol (94%). While women who used misoprostol were significantly more likely to answer positively to the acceptability questions, the difference was quite small and in none of the acceptability indicators did non-users respond less than 90%.
Feasible-Community Awareness Campaign: The health facility was the most cited and most important source of information for PPH and misoprostol amongst respondents. Feasible for scale-up.Effective-Coverage of miso at home births: Based on a previous study conducted in Kigoma, we can estimate that use of misoprostol may have prevented 94 cases of PPH that would have occurred at home deliveries in the absence of an uterotonic (18.5% of deliveries) (Prata, Mbaruku et al. 2005) and would have required referral and additional interventions. Since even preliminary results are demonstrating the safety, feasibility, effectiveness, and acceptability of misoprostol distribution at ANC, we STRONGLY recommend planning now the scale-up of integration of misoprostol into existing ANC services.
Subsequent to dissemination of this OR, TZ added miso to its Mama Packs; revised national projections for miso and placed MSD order. Other activities VSI supports – working with AGOTA & PRINMAT to train on miso fro PPH & PAC.Other countries with high ANC and significant N women delivering at home; CBD of miso looks different in other country programs, eg Northern Nigeria – community drug vendors distribute miso…Lots of organizations here are working to save women’s lives; propose we look to see how miso for PPH and PAC can be easily, effectively integrated into your programs; I’ll be available through lunch for questions and I have materials, including supporting research and policy docs and program highlights
Maternal Health Innovations_Graves_5.13.11
Protecting mothers from PPH at home births with misoprostol:From national advocacy to community-based distribution<br />Alisha Ann Graves, MPH<br />Senior Program Manager, VSI<br />1<br />
Simple to administer without skilled attendance</li></ul>Ideal in low-resource settings & supported by international health organizations<br />3<br />
Key agencies have recognized the role of misoprostol in different settings to avoid maternal mortality<br />FIGO/ ICM 2006 Call to Action<br />“the different setting where women give birth…require different strategies to prevent and treat PPH.”<br />“…in home births without a skilled attendant, misoprostol may be the only technology available to control PPH.”<br />4<br />
Global Policy (cont.)<br />WHO Recommendations on the Prevention of PPH (2007)<br />“In the absence of AMTSL, a uterotonic drug (oxytocin or misoprostol) should be offered by a health worker* trained in its use for prevention of PPH”<br />*auxiliary nurse-midwives, community midwives, village midwives, and health visitors—if they have been specially trained, qualify<br />Update<br />WHO added misoprostol to its Model List of Essential Medicines for prevention of PPH (May 2011, unedited report)<br />-was previously included for treatment of incomplete abortion<br />5<br />
2004 misoprostol registration status(Approximated)<br />Registered for postpartum hemorrhage (PPH) and treatment of incomplete abortion* <br />Registered for PPH and other ob/gyn indication*<br />Registered for PPH*<br />Registered for another ob/gyn indication (not PPH)<br />Registered for gastric ulcers only<br />*Misoprostol may or may not be registered for gastric ulcers<br />6<br />
2010 misoprostol registration status<br />Last updated: August 2010<br />Registered for postpartum hemorrhage (PPH) & treatment of incomplete abortion* <br />Registered for PPH and other ob/gyn indication*<br />Registered for PPH*<br />Registered for another ob/gyn indication, not PPH*<br />Registered for gastric ulcers only<br />*Misoprostol may or may not be registered for gastric ulcers<br />7<br />
Government policies set level of access guidelines and public sector procurement<br />8<br />
Preventing PPH at home-births in Tanzaniathrough antenatal care (ANC) distribution of misoprostol<br />OPERATION RESEARCH<br />Goal: Assess the feasibility, safety, program effectiveness, and acceptability of distribution of misoprostol through ANC visits<br />Conducted in four districts of Tanzania (January - December 2009)<br />Collaborating Institutions:<br />9<br />
Misoprostol Distribution at > 32 weeks gestation</li></ul>Reduce PPH at Home Births<br />11<br />
12<br />Program EffectivenessBirths Protected from PPH<br />n= 6,735<br />Green color = Birth protected from PPH by use of uterotonic after delivery<br />
SafetyCorrect Use of Misoprostol<br />Almost all 1,826 women who took misoprostol at home reported using the drug correctly:<br />Correct dose (3 tablets)= 99.5%<br />Correct route (oral) = 98%<br />13<br />
Women feel more secure and protected from PPH</li></ul>15<br />
Select Policy Implications<br />Scale-up within Tanzania and beyond<br />Consider other mechanisms of misoprostol distribution for self-administration<br />Misoprostol should be available in all delivery rooms<br />16<br />