Comparing two methods of pain relief during labor in first-time mothers
Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Nulliparous Women. A Randomized Controlled Trial
NA · Holy Family Hospital, Nazareth, Israel · NCT06494280
This study is testing whether a new way of giving epidural pain relief during labor can help first-time moms feel less pain and be more satisfied compared to the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Sex | Female |
| Sponsor | Holy Family Hospital, Nazareth, Israel (other) |
| Locations | 1 site (Nazareth) |
| Trial ID | NCT06494280 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of programmed intermittent bolus epidural analgesia (PIBEA) versus continuous epidural infusion (CEI) in managing breakthrough pain during labor in nulliparous women. Participants will be randomly assigned to receive either PIBEA, which delivers pain relief at scheduled intervals, or CEI, which provides a continuous dose. The study will assess outcomes such as the incidence of breakthrough pain, labor duration, and overall satisfaction with pain management. The goal is to determine if PIBEA can improve pain relief and reduce the need for additional interventions compared to CEI.
Who should consider this trial
Good fit: Ideal candidates for this study are nulliparous women in the latent phase of labor with a singleton vertex presentation who request epidural analgesia.
Not a fit: Patients who may not benefit include those with contraindications for epidural analgesia or complications such as estimated fetal weight over 4 kg.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management during labor and enhance the overall experience for first-time mothers.
How similar studies have performed: Previous studies have shown promising results for similar techniques in pain management during labor, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nulliparous women * Term pregnancy * Singleton * Vertex presentation * Latent phase (cervical dilatation \<6 cm) * Epidural analgesia request * Visual Analogue Scale score \> 40 Exclusion Criteria: * Estimated fetal weight \> 4 kg * Intra uterine fetal death * Drug sensitivity * Anomalous fetus * Contraindication for epidural analgesia
Where this trial is running
Nazareth
- Holy Family Hospital — Nazareth, Israel (RECRUITING)
Study contacts
- Study coordinator: Raed Salim, MD
- Email: r.salim@hfhosp.org
- Phone: +972544986960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breakthrough Pain, Nullipara, Term pregnancy, Singleton, Vertex presentation, Latent phase, Maternal request for epidural, Visual analogue scale > 4