International Federation of Gynecology and Obstetrics

Millennium Development Goal 5 (MDG 5)

Two targets:

Reduce by three quarters, between 1990 and 2015, the maternal mortality ratio

Achieve, by 2015, universal access to reproductive health

BACKGROUND

Women's mortality and morbidity related to pregnancy, and the ensuing impact on perinatal mortality, remains unacceptably high, particularly in low resource countries across sub-Saharan Africa and South Asia where almost all these deaths occur and where a high percentage of women deliver at home or outside a health facility without immediate recourse to emergency obstetric care or a skilled birth attendant. It is widely acknowledged that post-partum haemorrhage (PPH) is the most significant contributor to maternal mortality and morbidity worldwide with, according to The Millennium Development Goals Report 2010, 35 per cent of maternal deaths resulting from haemorrhage.

The most common cause of PPH is uterine atony, or failure of the uterus to contract after delivery. In health care facilities, Active Management of the Third Stage of Labour (AMTSL), including the use of uterotonics, is the recommended standard practice for all births in order to prevent and treat PPH. The gold-standard uterotonic for PPH is oxytocin. For optimum use oxytocin requires refrigeration, intravenous or intramuscular infusion, and skilled providers. These factors can hinder its use in low resource settings. In some countries, hospitals or health regions, uterotonics require a specific order by a physician. These requirements may create dangerous delays in appropriate management by skilled birth attendants.

Originally developed to treat gastric ulcers, misoprostol has since attracted great interest in sexual and reproductive health circles and is increasingly used ad hoc for PPH prevention and treatment. In settings where injectable uterotonics are neither available or feasible, misoprostol, a synthetic E1 prostaglandin analogue, has increasingly been adopted as an alternative intervention strategy for the management of PPH - one endorsed by FIGO.  Misoprostol is available in tablet form, relatively inexpensive, is stable at room temperature, well absorbed orally and sublingually, and requires few skills to administer.

ABOUT THE FIGO INITIATIVE

FIGO is dedicated to the improvement of women’s health and rights, the reduction of disparities in health care available to women and newborns, and the advancement of the science and practice of obstetrics and gynecology.

In September 2010, FIGO signed an agreement with Gynuity Health Projects to collaborate in the second phase of a project funded by the Bill & Melinda Gates Foundation which sets out to address a range of scientifc, operational and policy questions around the use of misoprostol for PPH care, and to look at ways to translate research into effective policies, programmes and practice. The project partners include: Aga Khan Development Fund, Family Care International (FCI), FIGO, Guttmacher Institute, Gynuity Health Projects, PATH, Population Services International (PSI), University of Liverpool, University of Illinois, Chicago/UCSF, World Health Organization (WHO), Ministries of Health, hospitals, providers, advocates and networks globally.

Project Team

Project Director - (FIGO Chief Executive) Hamid Rushwan

Project Manager - Clare Waite

Financial Administrator - Raj Waghela

Project Period

Phase I: September 2010 – October 2012

Phase II: November 2012 – October 2014

Project Purpose

To advocate for and disseminate evidence-based information on misoprostol for PPH aimed at healthcare providers and clinical policy makers

Project Objectives

Objective 1 – To act as a ‘guiding’ organisation for advocacy among the medical community and health professionals;

Objective 2 – To disseminate information on strong evidence-based results related to the effectiveness and greater use of misoprostol;

Objective 3 – To develop materials for dissemination, including guidelines and protocols for professional groups on the use of misoprostol for PPH.

Working closely with the FIGO Committee for Safe Motherhood and Newborn Health, professional associations, and other like-minded organisations, FIGO’s project activities will include conducting expert panel sessions at regional meetings of obstetricians and gynaecologists to highlight the findings of evidence-based clinical studies and to introduce planned operational studies; publishing scientific articles in the International Journal of Gynecology and Obstetrics (IJGO); producing an IJGO supplement; conducting a half-day session at the 2012 FIGO World Congress in Rome; developing user-friendly education and training materials for professional associations and health personnel; offering assistance in the development of guidelines, protocols, and other materials for professional groups at the national level; and conducting national workshops in support of national activities.

FIGO endorses the administration of misoprostol in situations when safe administration and/or appropriate storage conditions for injectable oxytocin and ergot alkaloids are not possible.

A special editorial by Professor Hamid Rushwan - Misoprostol: An essential  medicine for managing postpartum hemorrhage in low-resource settings? - was published in the September 2011 issue of the IJGO.

PUBLISHED EVIDENCE: CLINICAL AND OPERATIONAL STUDIES

WHO MODEL LIST OF ESSENTIAL MEDICINES - 18th Expert Committee on the Selection and Use of Essential Medicines

The 18th Expert Committee on the Selection and Use of Essential Medicines took an important step when it approved the addition of misoprostol for the prevention of PPH to the WHO Model List of Essential Medicines.

In its unedited report made public in May 2011 following a review of the efficacy, safety, and cost-effectiveness of this and other medicines, the Committee took the decision to move misoprostol from the Complementary List to the Core List and to amend the list to include “…and for the prevention of postpartum haemorrhage where oxytocin is not available or cannot be safely used.” The Committee noted that there is “some evidence that 600mcg given orally is effective and safe” and that new evidence submitted showed that “misoprostol can be safely administered to women to prevent post-partum haemorrhage by traditional birth attendants or assistants trained to use the products at home deliveries.” The Committee further noted that, although misoprostol was not added to the list for its treatment indication, current WHO guidelines recommend the use of misoprostol for prevention and treatment indications in settings where it is not possible to use oxytocin or another injectable uterotonic.

EXPERT PANEL SESSIONS – REGIONAL MEETINGS of OBSTETRICIANS and GYNAECOLOGISTS

FIGO is sponsoring a series of expert panel sessions on the use of misoprostol for PPH as part of a joint initiative with Gynuity Health Projects to increase access to evidence-based clinical and operational research to a global audience of obstetricians and gynaecologists. In 2012, sessions will be convened at several congresses, including:

All India Congress of Obstetrics & Gynaecology (AICOG 2012)

Location: Varanasi, India (Swatantrata Bhawan, Banaras Hindu University)

Dates: 26-30 January 2012

Congress Website: http://www.aicog2012varanasi.com/about-us.php

Session Title: Misoprostol for the prevention and treatment of post-partum haemorrhage: From clinical evidence to operational realities

Session Chair:  Prof Sir Sabaratnam Arulkumaran
 - The role of misoprostol at different levels of the health system in India (Dr Alka Barua, India)
 - An analysis of clinical indicators of post-partum haemorrhage (Wendy Sheldon, USA)
 - Universal prophylaxis versus secondary prevention - A comparison of two community-based strategies for the management of post-partum haemorrhage (Prof MB Bellad, India)

Royal College of Obstetricians and Gynaecologists (10th International Scientific Meeting 2012)

Location: Kuching, Malaysia

Dates: 5-8 June 2012

Meeting Website: http://www.rcog2012.com/index.php

Session Title: Misoprostol for the prevention and treatment of post-partum haemorrhage: From clinical evidence to operational realities

Session Chair: Professor Hamid Rushwan (FIGO)
 - Misoprostol in the prevention of post-partum haemorrhage: Dr Nadeem Zuberi (Aga Khan University, Karachi, Pakistan)
- Sublingual misoprostol for the treatment of post-partum haemorrhage - Current evidence and programmatic implications: Prof Emad Darwish (University of Alexandria Faculty of Medicine, Alexandria, Egypt)
 - Sublingual misoprostol for treatment of postpartum haemorrhage - Dose and side effects: Jill Durocher (Gynuity Health Projects, New York, USA)
 - New clinical indicators and alternative strategies for managing post-partum haemorrhage: Holly Anger (Gynuity Health Projects, New York, USA)
- Scaling up misoprostol for the prevention of post-partum haemorrhage at the community level: the Nepal experience - Swaraj Rajbhandari (Senior Reproductive Health Specialist, Nepal)

INTERNATIONAL MEETINGS
The Product Problem: Pathways for Making Misoprostol Available for Post-Partum Hemorrhage, New York, March 2011

In March 2011, Gynuity Health Projects convened a meeting to clarify pathways for moving forward in accordance with scientific evidence to foster availability of misoprostol and its use for postpartum hemorrhage indications. Over 50 participants from around the world gathered to discuss what registration means, how it can be optimally pursued, where registration fits in the context of making misoprostol available to meet women’s and health systems needs, and how and when it might make sense to proceed without product registration. A meeting report is available at the Gynuity Health Projects website: http://gynuity.org/resources/info/pathways-for-making-misoprostol-available-for-postpartum-hemorrhage-en/