Active Studies
The ABC (Azithromycin: Brain neuroprotection for Children) Study
Current Research: This study is a prospective, masked, matched study evaluating the neurodevelopmental outcomes of children in the A-PLUS Trial. The ABC Study will enroll 420 birth asphyxiated infants (≥ 34 weeks of gestation) with no, mild, moderate, or severe hypoxic-ischemic encephalopathy (categorized by neurological examination using the Modified Sarnat Score) born to mothers who received either a single oral dose of 2 grams of azithromycin or placebo during labor in the A-PLUS trial, which aims to study the effectiveness of intrapartum azithromycin on reducing maternal and neonatal infections and deaths. Prospective and retrospective enrolled infants will undergo several developmental assessments by trained assessors at 24 (±1) months of corrected age (adjusting for Gestational Age).
Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE)
Current Research: This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2.
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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 2g azithromycin given to women in labor will reduce (1) maternal death or sepsis and (2) intrapartum/neonatal death or sepsis.
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A-PLUS AMR
Current Research: A sub-study of the A-PLUS trial in 1,000 women (and their infants) randomized to a single, prophylactic intrapartum oral dose of 2g azithromycin or placebo will be conducted to monitor antimicrobial resistance and microbiome diversity using nasopharyngeal and rectal swabs collected at baseline 0-1 day, 1 week, 6 weeks, 3 months, 6 months and 12 months postpartum.
More InformationCaffeine for Hypoxic Ischemic Encephalopathy (CHIME)
Current Research: CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE). The trial will recruit neonates who are diagnosed with HIE within six hours after birth based on physiologic criteria (acidosis noted on an umbilical cord or early [<1 hour] postnatal blood sample) and neurologic criteria (modified Sarnat exam consistent with encephalopathy).
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Intrapartum Azithromycin (IP AZM)
Current Research: The Intrapartum Azithromycin (AZ) Implementation Research (IR) study, a companion to the CHIME trial, focuses on the implementation of intrapartum azithromycin (IP AZM). It involves two phases: Phase 1, which focuses on formative research to identify barriers and facilitators to using IP AZM and guides the design of implementation strategies for Phase 2.
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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.
PRIORITY Trial
Current Research: The PRIORITY Trial is an upcoming prospective, two-arm, randomized trial in low-middle income countries expected to start enrolling in 2023. Women with moderate hemoglobin concentrations immediately post-delivery (6-48hrs) and who deliver at study hospitals or birthing facilities in Global Network sites will be enrolled into the trial. The trial is assessing whether at 6 weeks post-delivery if there is a difference in achievement of non-anemic state between women receiving IV iron compared to women receiving standard care with oral iron.
PRIORITY Implementation Research (IR)
Current Research: The PRIORITY Implementation Research (IR) sub study is conducted in parallel with the PRIORITY Trial in 2 PRIORITY Trial sites in Belagavi India, and Karachi, Pakistan. The IR study aims to generate evidence related to the implementation of an IV iron intervention (PRIORITY) for women in low- and middle-income countries and to identify factors that could facilitate or inhibit future adoption of the intervention, if it is proven effective. The findings of the IR study will be used to inform global guidelines on the use of IV iron postpartum, again, if the intervention proves effective.