Comparing Tramadol, Paracetamol, and Placebo for Pain Relief and Labor Outcomes in First-Time Mothers During Active Labor

What this Trial Is About

Researchers are evaluating the pain relief effects and obstetric outcomes of tramadol, paracetamol, and placebo in first-time pregnant women during active labor. This randomized, double-blind, placebo-controlled trial aims to compare how these treatments affect the duration of active labor and other important birth-related factors. The study focuses on nulliparous women and examines both maternal and newborn safety during labor and delivery. Participants receive a single intravenous dose of either tramadol 100 mg, paracetamol 1 g, or a saline placebo at the start of active labor, defined as cervical dilation of at least 4 cm with regular contractions. The study is carefully designed to keep patients and care providers unaware of the assigned treatment to ensure unbiased results. The treatments are administered by trained medical personnel following strict protocols. During the study, researchers collect data on labor duration, delivery type, use of oxytocin, and any side effects experienced by the mother or newborn. Pain levels are also measured before and after treatment. Safety monitoring continues up to 48 hours after birth. The trial includes regular assessments of labor progress and newborn health, with a total participation period covering labor through immediate postpartum. The study is funded and overseen by Universidad Nacional Autnoma de Honduras and conducted at Hospital Escuela in Tegucigalpa.

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