The Global Network for Women’s and Children’s Health Research is a partnership committed to improving maternal and infant health outcomes and building health research capacity in resource-poor settings by testing cost-effective, sustainable interventions. One of the United Nations Millennium Development Goals is to reduce child mortality by two-thirds by the year 2015 among children under 5 years old. Given that 38% of child deaths under age 5 years occur in the first 4 weeks of life, part of the focus has to be on preventing neonatal deaths. The Global Network supports and conducts clinical trials in resource-limited countries by pairing foreign and U.S. investigators, with the goal of evaluating low-cost, sustainable interventions to improve maternal and child health and simultaneously building local research capacity and infrastructure. These activities are designed to facilitate independent continuation of local research activities that will ultimately lead to improved health care systems and personal health.
The Global Network was initiated in 2001 as a public-private partnership between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Center for Research for Mothers and Children, and the Bill & Melinda Gates Foundation. The NICHD provides scientific oversight for the Global Network and all of its activities.
The Global Network currently includes a Data Coordinating Center (DCC) and six multidisciplinary research units around the world, each comprising a partnership between a research institution in a developing nation and one in the United States. The Global Network, which was re-competed in 2012, currently comprises dyads of investigators in the United States paired with senior foreign investigators in India, Pakistan, Guatemala, Zambia, Kenya, and the Democratic Republic of Congo.
Initially, the Global Network included 10 sites and a DCC, and it conducted 10 large, individual studies of interventions for important health problems in pregnancy and birth. Today, the Global Network focuses on community-based common protocols, conducted at three or more sites, that address major maternal and newborn health challenges with the goals of evaluating low-cost, sustainable interventions to improve maternal and child health (MCH), evaluating trends in MCH mortality over time, and simultaneously building local research capacity and infrastructure. This unique position gives the NICHD the ability to identify gaps between science and practice and disseminate the research findings to inform local and national health policy. Each study examines either a novel evidence-based treatment or an innovative use of a proven treatment to improve the health, well-being, and survival of pregnant women and infants. All studies conform to U.S. and international ethical and safety guidelines.
During the Global Network’s tenure, several NIH Institutes and Centers, including the National Institute of Dental and Craniofacial Research, the National Center for Complementary and Alternative Medicine, the Fogarty International Center, and the National Cancer Institute, in addition to the Bill & Melinda Gates Foundation, have supported projects or parts of projects conducted by the Network.
In addition, the Global Network builds partnerships with national, international, and nonprofit organizations, such as the World Health Organization, the United States Agency for International Development, and the American Academy of Pediatrics. Through these partnerships, the Global Network provides evidence that can be used for program development and advocacy, informs decisions about health policy, assists in scaling up effective interventions, and builds infrastructure.
The Global Network’s DCC, RTI International (which is based in North Carolina), provides protocol and data management, information technology, and logistical and statistical support to Global Network projects.
Current trials include:
- Maternal Newborn Health Registry. The primary purpose of this prospective, population-based observational study of approximately 60,000 women per year is to quantify and understand the trends in pregnancy services and outcomes over time in defined, low-resource geographic clusters. All pregnant women in participating clusters are registered and their outcomes tracked for 6 weeks following delivery. The registry has been ongoing since 2008.
- Antenatal c orticosteroids ttrial in preterm births to increase neonatal survival in developing countries. In collaboration with the World Health Organization, this randomized controlled trial seeks to reduce neonatal mortality by better identifying women at high risk of preterm delivery. The four components of the intervention are the following : (1) diffusing recommendations to health c are providers for the antenatal use of corticosteroids ; (2) training health c are providers to identify the signs of preterm labor and eligibility criteria for antenatal use of corticosteroids among pregnant women; (3) providing reminders to health c are providers on the use of the kits; and (4) using a color-coded tape to measure uterine height in order to estimate gestational age in women at risk of preterm delivery with unknown gestational age. The trial started in October 2011, and enrollment is ongoing. As of July 2013, 3, 817 high- risk pregnancies had been identified, of which 3,617 included the use of antenatal corticosteroids. A paper about the methods used in the trial has been published (Althabe, F., Belizán, J. M., Mazzoni, A., Berrueta, M., Hemingway-Foday, J., Koso-Thomas, M.,…Buekens, P. (2012). Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: study protocol. Reproductive Health, 9, 22. PMID: 22992312).
- Helping Babies Breathe (HBB) initiative. The HBB initiative represents a development of the Global Network FIRST BREATH trial, which was designed to provide skilled birth attendants to babies wherever they are born. HBB is being rolled out globally by the Global Network, the American Academy of Pediatrics, and USAID and its partners Saving Newborn Lives and Laerdal, Inc. It was field tested in five sites, two of which were Global Network sites in Kenya and Belgaum, India; field testing included the development of a new low-cost neonatal simulator and resuscitation bag. USAID requested that the Global Network evaluate the impact of Helping Babies Breathe on neonatal survival; this evaluation is under way in three Global Network sites, one in Kenya and the other two in Nagpur and Belgaum, India. Seventy-one participating facilities that provide delivery care for pregnant women living in Global Network communities have trained a total of 1,636 birth attendants as of June 2013. An i mpact evaluation will be completed in October 2013.
- Women First: Preconception Maternal Nutrition study. The primary hypothesis of this study is that newborns of women in poor communities who receive a comprehensive maternal nutrition intervention starting at least 3 months prior to conception and continuing throughout pregnancy will be significantly longer than those infants whose mothers start to receive the same intervention at 12 weeks of gestation or infants whose mothers do not receive the intervention at all. Enrollment will start in August 2013; the goal will be 1,440 women per site.
- Ultrasound study. This multi-country cluster randomized trial will assess the impact of antenatal ultrasound screening performed by community physicians and nonp hysician health care staff in low-resource community settings. The study will be conducted with the support of the Bill & Melinda Gates Foundation, GE Healthcare, and the University of Washington, The study’s first hypothesis is that ultrasound will increase the rate of prenatal care utilization and appropriate utilization of delivery facilities for women with complicated pregnancies. The second hypothesis is that antenatal ultrasound screening performed by community physicians and non physician health care staff will decrease a composite outcome of maternal mortality, maternal near-miss mortality, and stillbirth and neonatal mortality. The planned start date is January 2014.
- India (2 sites)
- Christiana Care Health Services (Newark, DE)
- Columbia University
- Indiana University-Purdue University Indianapolis
- Massachusetts General Hospital (Boston, MA)
- Tulane University
- University of Alabama at Birmingham
- University of Colorado, Denver