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In
this section you will find information on Gynuity's work to
develop regimens for misoprostol use in several areas:
Advances
in health care do not always require the invention of new
technologies or new drugs. Sometimes, it is possible to make
substantial improvements in health care merely by adapting
existing technology or changing the way drugs are used. Looking
at new ways to use what is already on hand can be more economical
and faster than searching to invent new technologies from
scratch. Gynuity Health Projects tries to maximize the capacity
of already-existing technology and apply it to improve the
health of women and the quality of the health care services
they receive.
Misoprostol
Globally, 585,000
women die each year from complications of pregnancy and childbirth.
The United Nations Millennium Development Goals call for all
United Nation member states to reduce their maternal mortality
ratios by an ambitious 75 percent before 2015. Efforts in
pursuit of these goals include managing hemorrhage, infection,
unsafe abortion, eclampsia, and obstructed labor, all major
causes of maternal mortality.
Development of misoprostol for its reproductive health indications
could significantly improve maternal health. Misoprostol is
a prostaglandin analog that is registered in over 60 countries
for treatment and prevention of gastric ulcers caused by prolonged
use of anti-inflammatory medications. It is widely used “off-label”
for a number of reproductive health indications.
Gynuity Health Projects
tracks the approval of misoprostol throughout the world. To
download a global map that reflects our latest information
about the registration of misoprostol, follow this link:
> Map of misoprostol
approval 
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Misoprostol for Treatment of Miscarriage
and Incomplete Abortion
Of all recognized pregnancies, 15 to 20 percent are miscarried
or become non-viable in the first half of pregnancy. Traditionally,
when an early pregnancy is miscarried or fails to develop,
the treatment is with curettage or vacuum aspiration, including
manual vacuum aspiration (MVA). In the developing world, where
access to care is often limited, women may have difficulty
in obtaining such services. In addition, serious complications,
such as uterine perforation, cervical laceration, and infection
occasionally occur.
Women frequently express a wish for less invasive treatment
for this common life event. Given these circumstances, there
is growing support for medical management of early pregnancy
loss, which would give women a way to avoid a surgical procedure
and might provide a much safer and more reliable treatment
where resources are limited. Investment in misoprostol may
significantly contribute to a reduction in maternal mortality
associated with failed pregnancy.
Misoprostol stimulates uterine contractions and helps to evacuate
the uterus. Preliminary studies show that the treatment works
in more than 9 out of 10 women experiencing incomplete miscarriage.
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Current or planned Gynuity activities in this area include:
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Implementation
of clinical trials to gather reliable data
on optimal regimen(s) using misoprostol
for treatment of early pregnancy failure.
A randomized clinical trial comparing misoprostol
to standard care for treatment of incomplete
abortion is underway, with researchers in
Burkina Faso, Ghana, India,
Mozambique and Tanzania;
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Creation of regulatory files to register misoprostol for incomplete and missed abortion;
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Development of training and educational materials for policymakers, clinicians, and users; and
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Organization of seminars, educational opportunities and training courses to share information and stimulate interest in misoprostol’s potential for this use. |
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Download general information about Gynuity's approach to this
topic in PDF
While clinical research continues to develop a standard
of care for this indication, a consensus protocol reflecting
the best current information could greatly improve the quality
and consistency of guidance available to clinicians and women
and, ultimately, health outcomes for women. In June 2004,
Gynuity Health Projects and the Reproductive Health Technologies
Project convened a group of professionals with epidemiological,
clinical and programmatic expertise in use of misoprostol
for the treatment of incomplete abortion and miscarriage to
reach consensus on the appropriate usage of misoprostol for
this indication. The result can be found in a document called
“Instructions for Use: Misoprostol for Treatment
of Incomplete Abortion and Miscarriage.” The information
in this document may serve as a basis for the development
of clinical practice guidelines and patient and provider education
materials. This document will be periodically reviewed and
updated with current information and research developments.
| Follow this link to download this document in Arabic, English, French, Portuguese, Russian and Spanish. A reference list and annotated bibliography in support of these instructions are also available. |
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Follow this link to other documents
available on this topic:
> "Route
of misoprostol administration"
> "Misoprostol:
A new addition to post abortion care"
> "Misoprostol: An emerging
technology for women's health"
Other
Reproductive Health Indications
We are currently developing new ideas for research with misoprostol for other reproductive health indications. Please check back in the future for information on new projects.
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