Maternal, Newborn, and Adolescent Health

Population Services International (PSI) proposes to conduct a proof-of-concept study followed by a larger clinical trial in two public sector hospitals through FOGSI in India, to determine if a new intrauterine device (IUD) inserter, specifically designed for the postpartum setting, will improve service delivery. Pregna International will provide the inserters free of cost, and Stanford University will provide technical expertise in study design and implementation.

Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries. The majority of these deaths occur outside the health care system, and so an intervention that could be used in any setting and with minimal training could save lives. We will use an animal model to demonstrate appropriate uterine fill, and a proof-of-concept study to show stoppage of post-delivery bleeding and test ease of removal. Standard care for treating PPH consists of massage, uterotonics, and tamponade (i.e., "holding pressure").

We propose to roll out and evaluate a next-generation uterine balloon tamponade (UBT) device to arrest maternal hemorrhage in Kenya and Sierra Leone, where maternal mortality statistics are alarmingly high. We will deploy UBT as part of a best-evidence package of training, commodities, and checklists related to the treatment of PPH. We have established strong proof of concept for our package in these countries. The UBT system will also include cutting-edge cell phone technology that will facilitate UBT referral tracking and documentation of patient outcomes.

To increase vaccination coverage, we propose to develop a microneedle patch that co-administers the influenza and tetanus toxoid vaccines. Our approach is specifically designed to meet the needs of pregnant women and children under the age of 5 in developing countries by (i) seeking to prevent tetanus and influenza infection (ii) co-administering both vaccines with a simple-to-apply, thermostable patch that generates no sharps waste, thus improving safety by avoiding hypodermic needles.

The transmission of HIV from mother to child during the birthing process can be largely prevented by the administration of ARV drugs. But, the newborn must start receiving medication within 24 hours after birth to be most effective. In Zambia, only 22.1% of infants born at home to HIV+ mothers receive the medication they need because it is difficult to get the medicine to them.

Urgent shortages of medicines in low-income countries lead to millions of unnecessary deaths at birth every year. One pervasive challenge causing such shortages is how to move the right commodities to the right place on time and at cost. We propose to develop an open-source distribution management system which leverages our existing real-time dataset of stock transactions at thousands of facilities in Africa to drive automated improvements in practice.

We propose to create an inexpensive, easy-to-use, handheld system that detects the likelihood of the future onset of preeclampsia. A 50-patient clinical study will validate its effectiveness. Pregnant women can be scanned non-invasively and extremely inexpensively (no disposables required) in 5-10 minutes.

Although intrauterine devices (IUDs) are effective long-acting contraceptives, IUD insertion is very complex, so IUDs are often unavailable in resource poor settings. Bioceptive's proposal is to create a reusable IUD inserter for the developing world with the goals that it is intuitive, Cu380A IUD compatible, safer, and low cost. Bioceptive will develop a reusable version of its patent-pending IUD inserter that makes the insertion procedure easier and safer, allowing more women worldwide to take advantage of one of the most effective forms of contraception.

Devastating brain injury and neonatal death caused by hyperbilirubinemia (kernicterus) is very common in low resource settings (LRS) but can be prevented by early detection and treatment with light therapy. A major roadblock to the global effort to eliminate kernicterus is the inability to measure total plasma bilirubin (TB) in most LRS, including many referral hospital centers. To meet this need, we are developing an inexpensive Point-of-Care system that rapidly measures TB.

This project proposes to develop a rectal formulation of a third-generation cephalosporin antibiotic for reducing mortality through early community-based management of neonatal sepsis. It will carry out pharmaceutical and preclinical studies with the aim of developing a stable rectal formulation of a candidate antibiotic with adequate bioavailability. Selection will depend on activity against causative pathogens, a good safety profile, and central nervous system penetration. Rectal administration is a simple, safe, and acceptable method of treating sick children.