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Tests treatment safety and results for Labor Pain
Official title Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
ClinicalTrials.gov ID: NCT07440069
What this study is testing
What is Tramadol Hydrochloride?
Tramadol Hydrochloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for labor pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tegucigalpa, Francisco Morazán Department, Honduras
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 15 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tegucigalpa, Francisco Morazán Department, Honduras. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.