Actively Recruiting

Phase Not Applicable
FEMALE
Healthy Volunteers
NCT06494280

PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

Led by Holy Family Hospital, Nazareth, Israel · Updated on 2026-04-13

240

Participants Needed

1

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

Who Can Participate

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Nulliparous women
  • Term pregnancy
  • Singleton pregnancy
  • Vertex (head down) fetal presentation
  • Latent phase of labor with cervical dilation less than 6 cm
  • Request for epidural analgesia
  • Visual Analogue Scale (VAS) score greater than 40 for pain
Not Eligible

You will not qualify if you...

  • Estimated fetal weight over 4 kg
  • Intrauterine fetal death
  • Drug sensitivity
  • Fetal anomalies
  • Contraindication for epidural analgesia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Holy Family Hospital

Nazareth, Israel

Actively Recruiting

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Research Team

R

Raed Salim, MD

CONTACT

A

Asmaa Masri Esmail, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women | DecenTrialz