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Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor

RecruitingPhase 4Ages 15 Years - 45 YearsFemaleUniversidad Nacional Autonoma de Honduras
NCT07440069 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Tramadol Hydrochloride
  • Paracetamol (acetaminophen)
  • Placebo (Saline Solution)
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Where

2 sites
Hospital Escuela
Tegucigalpa, Honduras
Instituto Hondureño de Seguridad Social
Tegucigalpa, Honduras
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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