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

Phase 4

• Conditions: Anesthesia, Epidural; Labor Pain; Opioid
• Interventions: Drug: Sufentanil; Drug: Fentanyl

• Registration Number: NCT03344042
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-11-12
• Study First Posted: 2017-11-17
• Study Start: 2017-12-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-05
• Last Update Posted: 2018-12-06
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanyl	Sufentanil	10mcg sufentanyl administered into the epidural space during regular contractions before cervical dilation
Fentanyl	Fentanyl	100mcg Fentanyl administered into epidural space during regular contractions before cervical dilation

Primary Outcome Measures

Name	Time	Method
Pain intensity according to Numerical Rating Scale (NRS)	up to 24 hours	till 4cm cervical dilation in primigravida or 3cm multiparous

Secondary Outcome Measures

Name	Time	Method
Fetal heart rate	up to 24 hours	till 4cm cervical dilation in primigravida or 3cm multiparous
Blood pressure parturient	up to 24 hours	till 4cm cervical dilation in primigravida or 3cm multiparous
Heart rate of parturient	up to 24 hours	till 4cm cervical dilation in primigravida or 3cm multiparous

Trial Locations

Locations (1)

Uniwersyteckie Centrum Zdrowia Kobiety i Noworodka, WUM; 🇵🇱 Warszawa, Mazowieckie, Poland