{"id":"nct:NCT03871491","kind":"trial","title":"Azithromycin-Prevention in Labor Use Study (A-PLUS)","authors":["NICHD Global Network for Women's and Children's Health"],"author_count":1,"year":2019,"published":"2019-03-12","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT03871491","source_url":"https://clinicaltrials.gov/study/NCT03871491","archive_url":"https://space-kitty.com/papers/nct:NCT03871491","updated":"2024-10-24","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"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. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Maternal Death","Maternal Infections Affecting Fetus or Newborn","Neonatal SEPSIS","Maternal Sepsis During Labor","Neonatal Death","Postpartum Sepsis"],"details":{"acronym":null,"status":"COMPLETED","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":58747,"sponsor":"NICHD Global Network for Women's and Children's Health","conditions":["Maternal Death","Maternal Infections Affecting Fetus or Newborn","Neonatal SEPSIS","Maternal Sepsis During Labor","Neonatal Death","Postpartum Sepsis"],"interventions":["DRUG: Azithromycin","DRUG: Placebo"],"start_date":"2020-09-01","start_date_type":"ACTUAL","primary_completion_date":"2022-09-30","has_results":true,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"infectious-disease-amr","name":"Infectious Disease, Vaccines & Antimicrobial Resistance","domain_slug":"medicine"}],"cited_in_dossiers":[]}