Posts Tagged ‘Gynuity Health Projects’

Misoprostol for postpartum hemorrhage: from evidence to action

Monday, August 1st, 2011 by Christopher Lindahl

Written by: Shafia Rashid, Senior Program Officer, FCI Global Advocacy program.

 

The following was originally posted on FCI’s blog. It is reposted here with permission.

 

Around the corner from the New York Stock Exchange, where financial decisions of global importance are made every day, more than 50 obstetricians, midwives, women’s rights advocates, public health programmers, researchers, and policy makers from around the world gathered last week for discussions on a different, but equally momentous, subject. FCI, working in collaboration with Gynuity Health Projects, brought together this diverse group for a two-day meeting to help shape policy and advocacy on the use of the drug misoprostol for the prevention and treatment of postpartum hemorrhage (PPH). In the developing world, uncontrolled post-partum bleeding is the leading cause of death in childbirth, killing a woman every five minutes.

 

In studies conducted by Gynuity and others, misoprostol has been shown to be a safe and effective medicine both for the prevention and for the treatment of PPH. While another drug, oxytocin, is generally recognized as the “gold standard” among uterotonic drugs for preventing or treating PPH, misoprostol has significant advantages for use in settings where maternal mortality is high and most births take place outside of hospitals: misoprostol is delivered in tablet form, and — unlike oxytocin — requires neither refrigeration nor intravenous administration. Earlier this year, misoprostol was added to the World Health Organization’s Model List of Essential Medicines for the prevention of PPH, providing another opportunity to expand women’s access to this safe and inexpensive medicine. Misoprostol, originally developed for treatment of stomach ulcers, is also used for a range of reproductive health indications, including induction and augmentation of labor and medical abortion.

 

The New York meeting aimed to translate the scientific evidence on misoprostol’s safety and efficacy into effective strategies for expanding women’s access to misoprostol at the country level. After reviewing the scientific research, the global clinical and policy guidelines that shape the use and availability of misoprostol, and the strategies being used by misoprostol advocates and programmers, participants discussed opportunities, barriers, and challenges related to promoting greater access to misoprostol for PPH. Human rights experts framed how access to misoprostol is a human right enshrined in several international frameworks, including the Universal Declaration of Human Rights. Presentations and discussions highlighted the need not only to drive policy change at the country level (e.g., getting misoprostol registered for this indication, including it on national essential drug lists, and incorporating it within national clinical norms and guidelines), but also to ensure that these policies are adequately implemented and funded so that they translate into real progress for women.

 

Presenters from Nepal, Kenya, and Ecuador shared lessons from successful efforts to achieve policy approval and expand distribution of misoprostol, and participants from countries including India, Tanzania, Uganda, Burkina Faso, and Laos also contributed their experiences. These discussions included promising results from several countries where distribution of misoprostol tablets to women in their communities has proven effective in addressing the risk of hemorrhage among women who give birth at home — where more than half of births in the developing world still take place — with extremely low levels of diversion of the drug for other uses, incorrect dosage or timing of administration, or other signs of poor compliance. Attendees also learned about advocacy campaigns in related sectors, including emergency contraception, medical abortion, and the HPV vaccine for cervical cancer, and considered how those lessons may be applied to improving access to misoprostol for PPH.

 

Looking ahead, FCI will work with our partners to develop and implement an advocacy and communications strategy that will drive real progress in helping countries, health care providers, and women themselves address the leading cause of maternal death. Please stay tuned to The FCI Blog for more information as this exciting and important project moves forward.

 

To read FCI’s mapping report on advocacy for access to misoprostol, click here: Mapping_Miso_For_PPH.

 

To read about FCI’s work on misoprostol for PPH, click here.

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Decision on Addition of Misoprostol to WHO EML for Treatment & Prevention of Postpartum Hemorrhage

Monday, May 23rd, 2011 by Christopher Lindahl

May 19, 2011

 

Dear Colleagues:

 

It has been several months since you lent your support to add misoprostol for prevention and treatment of post-partum hemorrhage (PPH) to the World Health Organization’s (WHO) Model List of Essential Medicines. The 18th Expert Committee on the Selection and Use of Essential Medicines met in Accra, Ghana in March 2011 to review the applications for misoprostol to be added to the WHO’s essential medicines list (EML) for the prevention and treatment of PPH. There was a huge outpouring of support for the inclusion of misoprostol for both indications by international policy-making and programmatic agencies and outside expert reviewers that positively reviewed both applications.

 

On May 6th, the Expert Committee published its results which “add misoprostol to the [Essential Medicines] List, for the prevention of PPH in settings where parenteral uterotonics are not available or feasible.” Additionally the committee moved the drug from the complementary to the core list of essential medicines. The committee’s report cited a recently completed study from Pakistan, demonstrating that “there may be a benefit from use of misoprostol by traditional birth attendants or assistants trained on the use of the product at home deliveries. Unfortunately, the committee did not approve the inclusion of misoprostol for its specific PPH treatment indication at this time. The unedited draft report is available on the WHO website at: http://www.who.int/medicines/publications/unedited_trs/en/index.html.

 

Regarding misoprostol for PPH treatment, the committee expressed some concerns which led to their decision to withhold approval at this time. The major stumbling blocks noted by the committee appear to be concerns about the very limited (e.g. no) data to support the use of misoprostol for treatment of PPH among women who have previously received prophylactic misoprostol to prevent PPH as well as about possible side effects after 800 micrograms (mcg) of sublingual misoprostol. . The committee also indicated a worry that any recommendation to use misoprostol for both PPH prevention and treatment could reduce attempts to make oxytocin more available. It is important to underscore however, that the committee also noted in its report that WHO guidelines and other internationalguidelines recommend misoprostol for both the prevention and treatment of PPH due to atony, where parenteral uterotonics are not available.

 

We are pleased that the EML will now include the 200-mcg tablet of misoprostol for its PPH prevention indication, in addition to:

  1. a 25‐mcg vaginal tablet, for use in induction of labor;
  2. a 200‐mcg tablet to be used in combination with mifepristone, for termination of pregnancy (where legally permitted and culturally acceptable);
  3. a 200‐mcg tablet for the management of incomplete abortion and miscarriage.

Moreover, the addition of misoprostol to the Core List is a strong validation of the drug’s role in women’s health. Future research will address misoprostol use for PPH treatment after its use for PPH prevention. Such use of the drug is certainly already a reality in places where oxytocin is not yet available and/or feasible to use. These results and other supportive data will be submitted to the Expert Committee on the Selection and Use of Essential Medicines again for consideration in two years.

 

Many organizations, including Gynuity Health Projects and Venture Strategies Innovations, continue to support the addition of misoprostol to the Model List of Essential Medicines for its specific post-partum hemorrhage treatment indication and will continue to advocate for its inclusion in the future.

 

We thank you again for your support of this issue.

 

Sincerely,

 

Jennifer Blum, M.P.H., Gynuity Health Projects
Ndola Prata, M.D., M.Sc., Venture Strategies Innovations, Associate Professor in Residence, University of California, Berkeley
Kirsten Moore, Reproductive Health Technologies Project

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Misoprostol in Pakistan event at USAID

Monday, January 10th, 2011 by Christopher Lindahl

Trained traditional birth attendants in Pakistan provide misoprostol to prevent postpartum haemorrhage: a randomised placebo-controlled trial

 

Jill Durocher, Program Associate, Gynuity Health Projects
Jennifer Blum, Senior Program Associate, Gynuity Health Projects

 

Monday, January 24, 2011
2:00-3:00 PM
Ronald Reagan Building
1300 Pennsylvania Avenue, NW
Washington, D.C. 20523
Room: 4.8 E/F

 

About the event: Postpartum haemorrhage (PPH) continues to be the leading single direct cause of maternal mortality worldwide. Despite global efforts to ensure that women deliver with skilled birth attendants and have access to conventional uterotonics for PPH prevention, 60% of births in low resource countries occur outside health facilities without a skilled attendant. In Pakistan, 65% of births occur at home and 27% of maternal deaths are attributed to PPH. Today’s talk summarizes results from a randomized controlled trial testing the impact of post-partum administration of 600 mcg oral misoprostol on PPH by Pakistani trained traditional birth attendants. The data show a 24% reduction in PPH among women given misoprostol after delivery. These results, in conjunction with other published reports on misoprostol for PPH prevention, support the drug’s effectiveness in preventing PPH in places where oxytocin is either not available or not feasible. We also hope that these results will bolster WHO support to list misoprostol for its specific PPH prevention indication on its Essential Medicines List.

 

Jill Durocher will share results from this newly published trial and discuss its implication for programs introducing misoprostol for PPH prevention. Jennifer Blum will be on hand to discuss how this relates to Gynuity’s current portfolio of work on misoprostol for the prevention and treatment of PPH globally.

 

Please join USAID and Gynuity Health Projects for this presentation—newly published in BJOG. All are invited. Please contact Tierra Smith (tsmith@usaid.gov) for pre-clearance into the building.

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Making Outpatient Abortion Services a Reality

Thursday, September 2nd, 2010 by KateMitch

Written by Janna Oberdorf, Women Deliver

Every year, an estimated 20 million unsafe abortions take place. And of all maternal deaths, unsafe abortion accounts for 13%. Imagine if we could change that. Imagine if we could make a serious dent in the deaths and morbidities that are caused from botched abortions, from unhygienic surgeries, and from unskilled providers.

Now, imagine if we could change that with a few simple, low-cost pills. That’s what the drugs mifepristone and misoprostol are doing for women around the world.

At today’s panel session on “Reducing the toll of unsafe abortion using simple medical technology” at the Global Maternal Health Conference in Delhi, panelists laid out the landscape of how introducing and expanding access to medical abortions could save lives and prevent injury:

•    Beverly Winikoff, of Gynuity Health Projects, talked about misoprostol as first-line treatment of incomplete abortion, and about introducing and expanding existing services and implications for training. As she said, misoprostol is low cost, and it can increase women’s choice and reduce the burden on doctors and health facilities.

•    Patricio Sanhueza Smith, from the Secretariat of Health in Mexico City, talked about lessons learned from Mexico City on the potential of misoprostol alone for transitioning services. He said, “Medical abortion with misoprostol alone is not the Gold Standard, but it is a duty to widely disseminate its use, while mifepristone becomes available.”

•    Selma Hajiri, of the Center for Research and Consultancy in Reproductive Health, talked about a randomized controlled trial of medical abortion with misoprostol only versus mifepristone plus misoprostol. She said that although the combination is the gold standard, misoprostol alone should be promoted where mifepristone is not accessible.

•    Kelsey Lynd, of Stanford University, spoke about making outpatient services a reality. She discussed research on administering mifepristone and misoprostol at home, and a pregnancy test that could simplify medical abortion provision.

•    Hillary Bracken, of Gynuity Health Projects, spoke about expanding access late in the first trimester, and the promise of outpatient mifepristone and misoprostol after 63 days.

Though I’m constantly amazed by the possibility and potential of mifepristone and misoprostol for safe abortion, I was even more amazed to hear about Kelsey Lynd’s work on making outpatient services a reality.

Having an abortion is a difficult and traumatic decision, with serious health repercussions. But that decision becomes so much harder when you have to pay for a sonogram to determine gestation period; to attend a clinic to take the mifepristone; to return to the clinic two week later for a follow-up visit and second dose; and to have a second sonogram to ensure the pregnancy was terminated. It’s a time-consuming and costly decision… but every one of those steps also takes an emotional toll.

Lynd presented research that showed that it is safe for women to self-administer mifepristone and misoprostol at home. Though this is great news for time and money saving reasons, it also gives women some control and choice over when to start their abortion.

Lynd also presented findings on a home pregnancy test that determine their pregnancy status after abortion. This semi-quantitative pregnancy test is administered at the health facility while the woman is pregnant to achieve a baseline of her hCG blood level. Then, 1 to 2 weeks after the woman has been administered mifepristone and misoprostol, she can use the test to check if her hCG blood level has decreased, thus confirming termination of pregnancy. In her findings, 98% of women felt they could use the test on their own in the future, and the tests identified ALL ongoing pregnancies.

The implications for this research are mind-boggling. I think it is obvious that cutting down clinic visits and sonograms would save time (for the woman and the provider) and save money. But it is the emotional implications that jump out at me. The ability for women to feel they have some control over their bodies and their abortions is something that is severely needed.

One last note is that although these findings are encouraging in making outpatient services a reality, they must be partnered with education, information, and counseling. Home abortions are a scary thing. Bleeding for days on end is a scary thing. And women need to understand complications that need treatment, and have some emotional support. We need to guide these women with the proper education, counseling, call centers, job-aids, and more, if and when we finally make outpatient services a reality.

Janna Oberdorf is the Communications Manager at Women Deliver.

Follow the Maternal Health Task Force and EngenderHealth on Twitter: @MHTF and @EngenderHealth. The conference hashtag is #GMHC2010.

For more posts about the Global Maternal Health Conference, click here.

For the live stream schedule, click here.

Check back soon for the archived videos of today’s presentations.

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