Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Labor Pain
In brief
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.
Key facts
- Study ID
- NCT07440069
- Run by
- Universidad Nacional Autonoma de Honduras
- People needed
- 300
- Starts
- 2026-02-15
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-02-27
Who can join
Age: 15 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Nulliparous pregnant women
- Age between 15 and 45 years
- Singleton pregnancy, term (37-41 weeks gestation)
- Cephalic presentation
- Active labor defined as cervical dilation ≥4 cm with regular contractions
- Signed informed consent
You may not qualify if…
- Multiple gestation or high-risk pregnancy (preeclampsia, gestational diabetes, etc.)
- Known allergy or contraindication to tramadol or paracetamol
- Recent use (less than 6 hours) of any analgesic medication
- Previous cesarean section or other uterine surgery
- Active infection or fever at admission
- Inability to provide informed consent due to mental or communication conditions
- Non-cephalic presentation
- Rupture of membranes >18 hours without labor
- Participation in another clinical trial within the last 3 months
Where it is running
- Hospital Escuela — Tegucigalpa, Francisco Morazán Department, Honduras (enrolling)
- Instituto Hondureño de Seguridad Social — Tegucigalpa, Francisco Morazán Department, Honduras (enrolling)
Full record on ClinicalTrials.gov
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