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Compares treatment options for Breakthrough Pain
Official title PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women
ClinicalTrials.gov ID: NCT06494280
What this study is testing
What is programmed intermittent Bolus epidural analgesia?
programmed intermittent Bolus epidural analgesia is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breakthrough pain.
Also referred to as Bupivacaine + Fentanyl.
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 randomized controlled trial is to examine the impact of programmed intermittent bolus epidural analgesia technique on the incidence of breakthrough pain during labor in nulliparous women compared to continuous epidural infusion. Nulliparous women will randomly be divided during labor into two groups; study group will receive mix of Bupivacaine and fentanyl once (bolus) every 60 minutes; the control group will receive continuously the same dose during an hour, until delivery.
- Which group you join is decided by chance.
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. Healthy volunteers may be eligible.
You may be able to join if
- Nulliparous women
- Term pregnancy
- Singleton
- Vertex presentation
- Latent phase (cervical dilatation \<6 cm)
You likely can't join if
- Estimated fetal weight \> 4 kg
- Intra uterine fetal death
- Drug sensitivity
- Anomalous fetus
- Contraindication for epidural analgesia
See the full eligibility criteria
- Nulliparous women
- Term pregnancy
- Singleton
- Vertex presentation
- Latent phase (cervical dilatation \<6 cm)
- Epidural analgesia request
- Visual Analogue Scale score \> 40
- Estimated fetal weight \> 4 kg
- Intra uterine fetal death
- Drug sensitivity
- Anomalous fetus
- Contraindication for epidural analgesia
The study team makes the final eligibility decision.
Where it's taking place
- Nazareth, 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nazareth, 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.