Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Recruiting
Phase 4
Interventional Study
Labor Pain
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 15 – 45
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Universidad Nacional Autonoma de Honduras · Other
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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 augme…
Trial Locations
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Eligibility Criteria
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…
Contacts