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Clinical Trials/NCT03344042
NCT03344042
Unknown
Phase 4

Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour

Medical University of Warsaw1 site in 1 country300 target enrollmentDecember 1, 2017

Overview

Phase
Phase 4
Intervention
Fentanyl
Conditions
Anesthesia, Epidural
Sponsor
Medical University of Warsaw
Enrollment
300
Locations
1
Primary Endpoint
Pain intensity according to Numerical Rating Scale (NRS)
Last Updated
7 years ago

Overview

Brief Summary

Epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase comfort and improve cooperation with medical personnel. Administering opioid into the epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous can effectively reduce the pain levels with no effect on the labour progress. The aim of the study is to compare different opioids administered in this early labour stage.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
December 20, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Medical University of Warsaw
Responsible Party
Principal Investigator
Principal Investigator

Jan Biławicz

Principal Investigator

Medical University of Warsaw

Eligibility Criteria

Inclusion Criteria

  • parturient in labour without cervical dilation and regular uterine contractions

Exclusion Criteria

  • no consent
  • known allergy to administered opioid
  • contraindications to epidural analgesia
  • coagulopathies including platelet count of less than 100,000
  • spine surgery in past

Arms & Interventions

Fentanyl

100mcg Fentanyl administered into epidural space during regular contractions before cervical dilation

Intervention: Fentanyl

Sufentanyl

10mcg sufentanyl administered into the epidural space during regular contractions before cervical dilation

Intervention: Sufentanil

Outcomes

Primary Outcomes

Pain intensity according to Numerical Rating Scale (NRS)

Time Frame: up to 24 hours

till 4cm cervical dilation in primigravida or 3cm multiparous

Secondary Outcomes

  • Fetal heart rate(up to 24 hours)
  • Blood pressure parturient(up to 24 hours)
  • Heart rate of parturient(up to 24 hours)

Study Sites (1)

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