NCT07440069 Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
| NCT ID | NCT07440069 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universidad Nacional Autonoma de Honduras |
| Condition | Labor Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-02-15 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2026-02-15 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07440069 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 45 Years, studying Labor Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07440069 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07440069 currently recruiting?
Yes, NCT07440069 is actively recruiting participants. Contact the research team at ricardo.gutierrez@unah.edu.hn for enrollment information.
Where is the NCT07440069 trial being conducted?
This trial is being conducted at Tegucigalpa, Honduras, Tegucigalpa, Honduras.
Who is sponsoring the NCT07440069 clinical trial?
NCT07440069 is sponsored by Universidad Nacional Autonoma de Honduras. The trial plans to enroll 300 participants.