Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor (NCT07440069)
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor: A Randomized Double-Blind Controlled Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Hospital Escuela — Tegucigalpa, Francisco Morazán Department
Age range: 15 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Hospital Escuela — Tegucigalpa, Francisco Morazán Department
- Instituto Hondureño de Seguridad Social — Tegucigalpa, Francisco Morazán Department
📞 Contact the Study Coordinator
Phone: +50497546940
Email: ricardo.gutierrez@unah.edu.hn
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.