Actively Recruiting
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Led by Universidad Nacional Autonoma de Honduras · Updated on 2026-02-27
300
Participants Needed
2
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Nulliparous pregnant women
- Age between 15 and 45 years
- Singleton pregnancy at term (37-41 weeks gestation)
- Cephalic (head-down) presentation
- Active labor defined as cervical dilation 64 cm with regular contractions
- Signed informed consent
You will not qualify if you...
- Multiple pregnancy or high-risk pregnancy (such as preeclampsia or gestational diabetes)
- Known allergy or contraindication to tramadol or paracetamol
- Use of any analgesic medication within 6 hours before enrollment
- Previous cesarean section or uterine surgery
- Active infection or fever at admission
- Unable to provide informed consent due to mental or communication issues
- Non-cephalic fetal presentation
- Rupture of membranes for more than 18 hours without labor
- Participation in another clinical trial in the last 3 months
AI-Screening
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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
Research Team
R
Ricardo A. Gutierrez-Ramirez, MD, MSc
CONTACT
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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