Condition: Labor Pain · Sponsor: Universidad Nacional Autonoma de Honduras
This randomized, double-blind, placebo-controlled trial aims to compare the analgesic efficacy and obstetric effects of tramadol (100 mg IV) versus paracetamol (1 g IV) versus placebo (saline solution) in nulliparous women during active labor. The primary outcome is duration of active labor (minutes). Secondary outcomes include duration of expulsive phase, type of delivery, need for oxytocin augmentation, maternal adverse events (nausea, vomiting, somnolence, hypotension), and neonatal outcomes (Apgar scores at 1 and 5 minutes, NICU admission). The study hypothesizes that tramadol significantly reduces active labor duration compared to paracetamol and placebo, without compromising maternal or neonatal safety. A total of 300 nulliparous women (100 per group) will be enrolled at Hospital Escuela, Tegucigalpa, Honduras.
This description comes directly from the study's public registry record.
Ricardo A. Gutierrez-Ramirez, MD, MSc · +50497546940 · ricardo.gutierrez@unah.edu.hn
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| Hospital Escuela | Tegucigalpa, Francisco Morazán Department, Honduras | Recruiting |
| Instituto Hondureño de Seguridad Social | Tegucigalpa, Francisco Morazán Department, Honduras | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07440069