Advancing Maternal and Newborn Health

Welcome to the AAA Pregnancy study page, where our focus is on practical research aimed at improving the health of both mothers and newborns. The study, titled “Antenatal micronutrients, aspirin, and azithromycin (AAA),” delves into a combination intervention for the maximal reduction of preterm birth and related outcomes. Take a closer look at our efforts to make a meaningful difference in maternal and newborn well-being.


Study Rationale

Pregnancy is a critical time, and babies born too early, known as preterm, face a dire challenge – many don’t survive the neonatal period. In 2020, one in four babies globally was preterm, small, or of low birthweight, termed “small vulnerable newborns.” Their survival is particularly challenging in low- and middle-income countries. The long-term sequelae of vulnerable births also cast a shadow, impacting the quality of life, and causing economic losses in society.

Preventing preterm birth and fetal growth restriction poses a multifaceted challenge due to numerous contributing factors. Limited resources exacerbate the complexity of the task. However, it’s noteworthy that maternal nutrition and infections or inflammation collectively contribute to over half of small vulnerable newborn cases in severely affected settings. As a result, the AAA pregnancy study aims to accelerate research for low-cost interventions, focusing on nutrition, infection, and inflammation strategies to emphasize holistic prevention.

Building on evidence from large trials, AAA pregnancy will study the impact of daily antenatal micronutrients and low-dose aspirin on the occurrence of preterm birth and related outcomes. Azithromycin will be integrated into this combination intervention (AAA), as a comprehensive approach in pregnancy to enhance newborn health and potentially mitigate long-term effects from vulnerable births, ultimately contributing to improved societal well-being.

The AAA Pregnancy study will be a pragmatic clinical trial, employing a randomized-controlled design to compare three approaches to routine antenatal care:

  1. Combination regimen with low-dose aspirin, multiple micronutrients, and azithromycin
  2. Combination regimen with low-dose aspirin and micronutrients alone
  3. Monotherapy with single-dose azithromycin

The trial will enroll 4000 pregnant women presenting early to initial antenatal care before 20 weeks of pregnancy. The primary study site is Botswana, with potential recruitment in other low-middle-income country settings.

Study Design

Outcome: The primary emphasis is on reducing preterm birth and fetal growth restriction.

Timeline: The study will span from 2024 to 2029.

Research Partners: The AAA Pregnancy study extends the success of the recently concluded Maduo study between Dr. Jeffrey Klausner and Dr. Chelsea Moroni focused on screening sexually transmitted infections to prevent adverse neonatal outcomes. Funded by the NIH (NIH R21HD100821), the Maduo study unveiled a notably high prevalence of Chlamydia trachomatis infection among pregnant mothers in Botswana. The study documented that a single 1g dose of azithromycin achieved a remarkable 100% cure rate. Screening and treating asymptomatic chlamydia significantly reduced the incidence of preterm birth and low birth weight among nulliparous pregnant women compared to those who remained unscreened.

Funding Partners: The AAA Pregnancy study is made possible through the generous support of Open Philanthropy.

Acknowledgments: We extend our gratitude to funders, study participants and global collaborators who contribute to advancing maternal and newborn health.

For more information, explore other research by the Klausner Research Group.