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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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Women First

Current Research: A study to test whether a nutrition intervention commencing at least 3 months before conception, will be associated with a greater newborn length compared to offspring whose mothers receive the same intervention at 12 weeks gestation or not at all.

Attention is increasingly directed to the role of maternal nutrition during the 1st trimester for normal growth and development during the first thousand days, from conception to the child's second birthday. The primary hypothesis of the Women First: Preconception Maternal Nutrition study is that for women in poor communities, a comprehensive maternal nutrition intervention commencing at least 3 months prior to conception and continuing throughout pregnancy, will be associated with a significantly greater newborn length than for offspring whose mothers start to receive the same intervention at 12 weeks gestation or who do not receive the intervention at all. The results of this trial will make a major contribution to refining evidence-based strategies for maternal nutrition supplementation and evaluating the cost-benefits of extending such strategies beyond pregnancy to virtually all women of child-bearing age, including adolescent girls.

Investigators
  • Nancy Krebs, MD, MS
  • Michael Hambidge, MD, ScD
  • Ana Garcés, MD, MPH
  • Richard Derman, MD, MPH
  • Bhalchandra Kodkany, MD, MBBS
  • Robert Goldenberg, MD
  • Omrana Pasha, MBBS, MSPH, DABIM
  • Carl Bose, MD
  • Antoinette Tshefu, MD, PhD, MPH
  • Elizabeth McClure, PhD
Institutions
  • University of Colorado Denver
  • Instituto de Nutrición de Centro América y Panamá
  • Christiana Care
  • JN Medical College, Belgaum, India
  • RTI International

  • Columbia University
  • Aga Khan University, Karachi, Pakistan
  • University of North Carolina at Chapel Hill
  • Kinshasa School of Public Health, Democratic Republic of Congo
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ASPIRIN

Current Research: 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. This prospective, randomized, placebo-controlled, double-blinded, multi-center clinical trial will examine whether low dose aspirin initiated between 6 0/7 weeks- 12 6/7 weeks gestation reduces the risk of PTB.

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