Four-year study to test effectiveness of WHO Safe Childbirth program

Harvard School of Public Health (HSPH) has been awarded a $14.1 million, four-year grant from the Bill & Melinda Gates Foundation to test the effectiveness of an innovative checklist-based childbirth safety program in reducing deaths and improving outcomes of mothers and infants in 120 hospitals in India. The program was developed by the World Health Organization (WHO) and HSPH.

Atul Gawande, associate professor in health policy and management at HSPH and a surgeon at Brigham and Women's Hospital, Boston, and co-principal investigator Jonathan Spector, research associate in health policy and management at HSPH and a neonatologist at Massachusetts General Hospital, Boston, are leading the BetterBirth clinical trial. The study will evaluate the impact of the WHO Safe Childbirth Checklist program at hospitals in Uttar Pradesh, India.

Of 130 million births annually in the world, nearly 350,000 result in the mother's death, 1 million in intrapartum stillbirth, and another 3.1 million in infant death during the neonatal period. Most deaths occur within 24 hours of delivery. In Uttar Pradesh the mortality rate for women giving birth is estimated at 440 per 100,000 births, vs. 254 per 100,000 births in the country as a whole. (By comparison, the maternal mortality ratio in the United States is 13 per 100,000 births.) Uttar Pradesh is one of India's least developed states, with 31% of its 190 million people living in poverty.

"To reduce these deaths, pregnant women are increasingly encouraged to deliver in health facilities instead of at home. But success requires a basic standard of care that is often missing," Gawande said. "At times, the problem is inadequate resources, but often the issue is a lack of handwashing or screening for use of available antibiotics. We designed a simple strategy to help facilities upgrade their performance."

The HSPH team worked with the WHO Departments of Patient Safety, Reproductive Health and Research, and Maternal, Newborn, Child and Adolescent Health to develop the Safe Childbirth Checklist program, which is expected to be released later this year. The checklist program aims to improve the safety of the mother and infant from the moment the woman enters a hospital, through labor and delivery, to discharge home. "The WHO Safe Childbirth Checklist program is intended to improve adherence not to just one but several clinical practices that have been shown to reduce death and complications for mothers and their newborn children," said Dr. Najeeb Al-Shorbaji, Acting Director of the Department of WHO Patient Safety.

"The program aims to transform behavioral patterns at the bedside - at times when the successful delivery of essential practices is crucial in order to reduce harm," said Spector. "Widely accepted protocols and guidelines have been distilled into a simple, user-friendly checklist program for frontline workers. It is introduced through initial safety training and reinforced through periodic coaching."