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Muhammad Usman, Muhammad Ashraf, Muhammad Imran Khokhar...
https://pubmed.ncbi.nlm.nih.gov/24250583Actively Recruiting
Phase 4
Age: 15Years - 45Years
FEMALE
Healthy Volunteers
ID07440069
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor A Randomized Double-Blind Controlled Trial
Led by Universidad Nacional Autonoma de Honduras · Updated on 2026-02-27
300
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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 Autónoma de Honduras and conducted at Hospital Escuela in Tegucigalpa.
CONDITIONS
Brief Title
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Who Can Participate
Age: 15Years - 45Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Nulliparous pregnant women
- Age between 15 and 45 years
- Singleton pregnancy, term (37-41 weeks gestation)
- Cephalic presentation
- Active labor defined as cervical dilation 64 cm with regular contractions
- Signed informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 hours from intervention administration
Participants receive a single intravenous dose of tramadol, paracetamol, or placebo at the onset of active labor and are monitored during labor.
1 intervention visit during active labor with pain assessments pre-intervention and at 30 minutes, 1 hour, and 2 hours post-intervention
Follow-up
Duration - Up to 48 hours after birth
Participants are monitored for maternal and neonatal outcomes up to 24 to 48 hours postpartum including adverse events and neonatal complications.
Approximately 1 to 2 post-delivery visits during hospital stay
Trial Site Locations
Total: 2 locations
1
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, Honduras, 11101
Actively Recruiting
2
Instituto Hondureño de Seguridad Social
Tegucigalpa, Francisco Morazán Department, Honduras, 11101
Actively Recruiting
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Research Team
R
Ricardo A. Gutierrez-Ramirez, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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