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Search / Trial NCT06494280

PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

Launched by HOLY FAMILY HOSPITAL, NAZARETH, ISRAEL · Jul 2, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Nullipara Term Pregnancy Singleton Vertex Presentation Latent Phase Maternal Request For Epidural Visual Analogue Scale > 4

ClinConnect Summary

This clinical trial is investigating how two different methods of providing pain relief during labor affect breakthrough pain in first-time mothers (nulliparous women). The study aims to see if a technique called programmed intermittent bolus epidural analgesia, which delivers pain relief medication in bursts every hour, is more effective than the standard continuous epidural infusion, where the medication is given steadily throughout labor.

To participate in this trial, women must be first-time mothers with a single baby in the head-down position, be in the early stages of labor (with less than 6 cm of cervical dilation), and have requested epidural pain relief due to significant pain. They will be randomly assigned to one of the two pain relief methods during their labor. It’s important to note that certain conditions, such as having a very large baby or specific health issues, would prevent someone from joining the study. Overall, participants can expect to help researchers learn more about effective pain management during labor, which could benefit future mothers.

Gender

FEMALE

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

About Holy Family Hospital, Nazareth, Israel

Holy Family Hospital, located in Nazareth, Israel, is a prominent healthcare institution dedicated to providing high-quality medical services and advancing clinical research. As a clinical trial sponsor, the hospital is committed to enhancing patient care through innovative research initiatives that explore new treatments and therapies. With a focus on patient safety and ethical standards, Holy Family Hospital collaborates with healthcare professionals and researchers to contribute valuable insights to the medical community, ultimately aiming to improve health outcomes for diverse populations.

Locations

Nazareth, , Israel

Patients applied

0 patients applied

Trial Officials

Raed Salim, MD

Study Chair

Holy Family Hospital, Nazareth, Israel

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported