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A-PLUS

Current Research: A randomized, placebo-controlled, parallel multicenter clinic trial to assess whether a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce (1) maternal death or sepsis and (2) intrapartum/neonatal death or sepsis.

Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. There is evidence that treatment with an oral dose of 2 g azithromycin vs. placebo for women in labor reduced certain maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS Trial (Azithromycin-Prevention in Labor Use Study) will assess the effect of a single oral 2 g dose of azithromycin given to women in labor on the prevention of maternal and neonatal deaths and infection. The trial will enroll 34,000 pregnant women at eight research sites in Latin America, South Asia, and sub-Saharan Africa who are in labor, ≥28 weeks gestational age with a live fetus pregnancy, and plan to deliver vaginally in a facility. The trial includes two primary hypotheses: (1) a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis; (2) a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis. There will also be a sub-study to assess the effect of the intervention on antimicrobial resistance and microbiome diversity.

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Maternal Newborn Health Registry

Current Research: A prospective, population-based pregnancy study in low-middle income countries. Sites enroll pregnant women and follow 6 weeks post-delivery. Enrolling 60,000 women/year, MNH quantifies services, and provides stillbirth, neonatal and maternal mortality rates to inform research.

Maternal Newborn Health Registry is a prospective, population-based study of pregnancies and their outcomes in low-middle income countries (DRC, Guatemala, India, Pakistan, Bangladesh, Zambia and Kenya). All pregnant women in participating clusters are registered and their outcomes tracked for 6 weeks post-delivery. 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. The goal is to provide population-based statistics on stillbirths, neonatal and maternal mortality as the basis of health care policy. The data from the registry also provide the mortality and morbidity outcomes for Global Network trials and help investigators plan future studies for the Global Network.

If you would like more information on this population-based study, including data forms, manual of operations and study protocol, please register using the following link:

Public Access Files

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ASPIRIN Neurodevelopment Follow-Up

Current Research: A total of 620 children will be enrolled in this study from six sites in sub-Saharan Africa, South Asia, and Latin America. Half of the children's mothers will have taken aspirin and half will have taken placebo. This will allow the researchers to compare results of the two groups of children and determine if children exposed antenatally to low dose aspirin will have no significant difference in neurodevelopmental behavior than those of their peers.

Preterm birth (PTB) remains the leading cause of neonatal mortality and long-term disability throughout the developed and developing world. A growing body of evidence suggests that 1st trimester administration of low dose aspirin can reduce the rate of PTB substantially. The Global Network developed and completed a randomized multi-center clinical trial to examine whether administration of aspirin between 6-12 weeks of pregnancy would reduce the risk of a pre-term birth(s). The ASPFU (ASPIRIN Neurodevelopment Follow-Up) study will examine the long-term neurodevelopment effects of aspirin in toddlers born from the ASPIRIN study (ClinicalTrials.gov).

US Institutions Foreign Institutions
University of North Carolina - Chapel Hill Kinshasa School of Public Health: Kinshasa, DRC
University of Alabama - Birmingham University Teaching Hospital: Lusaka, Zambia
Columbia University Aga Khan University, Karachi, Pakistan
University of Colorado - Denver Instituto de Nutrición de Centro América y Panamá (INCAP): Guatemala City, Guatemala
Thomas Jefferson University Jawaharlal Nehru Medical College: Belagavi, India
Boston University Lata Medical Research Foundation: Nagpur, India
Christiana Care  
RTI International  
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