NCT06494280 PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women
| NCT ID | NCT06494280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Holy Family Hospital, Nazareth, Israel |
| Condition | Breakthrough Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2026-11 |
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.
This trial targets 240 participants in total. It began in 2024-09-10 with a primary completion date of 2026-11.
⚠ 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
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.
Eligibility 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
Contact & Investigator
Raed Salim, MD
STUDY CHAIR
Holy Family Hospital, Nazareth, Israel
Frequently Asked Questions
Who can join the NCT06494280 clinical trial?
This trial is open to female participants only, studying Breakthrough Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06494280 currently recruiting?
Yes, NCT06494280 is actively recruiting participants. Contact the research team at r.salim@hfhosp.org for enrollment information.
Where is the NCT06494280 trial being conducted?
This trial is being conducted at Nazareth, Israel.
Who is sponsoring the NCT06494280 clinical trial?
NCT06494280 is sponsored by Holy Family Hospital, Nazareth, Israel. The principal investigator is Raed Salim, MD at Holy Family Hospital, Nazareth, Israel. The trial plans to enroll 240 participants.