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Compares treatment options for Pain Management
Official title Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor. Compare the Efficacy and Adverse Effects
ClinicalTrials.gov ID: NCT07264309
What this study is testing
What is pethidine?
pethidine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pain management.
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
- The goal of this intervention study is to compare the efficacy and adverse effects of pain relief during the first stage of labor using 75 mg IM pethidine versus the combination of IV 100 mg tramadol and 1000 mg paracetamol. The investigator assume that the combination of IV tramadol and paracetamol will be more effective with less adverse effects than IM pethidine in pain relief at the first stage of labor.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only
You may be able to join if
- Singleton Term pregnancy First stage of labor including at least 4 painful contractions in 30 min with cervical dilatation less or equal to 1 cm or...
You likely can't join if
- Previous cesarean delivery
- Malpresentation
- Multiple pregnancies
- Suspected intrauterine growth restriction \< 3 percentile
- Suspected placental abruption
- History of allergy to paracetamol, tramadol or pethidine
See the full eligibility criteria
- Singleton Term pregnancy First stage of labor including at least 4 painful contractions in 30 min with cervical dilatation less or equal to 1 cm or 50% effacement Spontaneous or induced labor -
- Previous cesarean delivery
- Malpresentation
- Multiple pregnancies
- Suspected intrauterine growth restriction \< 3 percentile
- Suspected placental abruption
- History of allergy to paracetamol, tramadol or pethidine
- Women with sleep apnea disorder
- Morbid obesity BMI≥40
- History of significant cardiac, liver and renal diseases
- Anti-convulsive medication consumption
- MAO inhibitors medication consumption within the last 14 days
- Non reassuring fetal heart rate monitoring (type II or III)
- Tense use
The study team makes the final eligibility decision.
Where it's taking place
- Afula, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Afula, Israel. 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.