About this trial
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.
Eligibility criteria
Qualifiers
Nulliparous pregnant women
Age between 15 and 45 years
Singleton pregnancy, term (37-41 weeks gestation)
Cephalic presentation
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tramadol Hydrochloride
- Paracetamol (acetaminophen)
- Placebo (Saline Solution)