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NCT03344042 Clinical Trial

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

Labor Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03344042
Other study ID # KB/46/2016
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 1, 2017
Est. completion date December 20, 2018

Study information
Verified date December 2018
Source Medical University of Warsaw
Contact Jan Bilawicz, MD
Phone 0048225830381
Email bilawicz@wp.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 20, 2018
Est. primary completion date December 20, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Fentanyl
100mcg Fentanyl
• Sufentanil
10mcg sufentanil

Locations
Country Name City State
Poland Uniwersyteckie Centrum Zdrowia Kobiety i Noworodka, WUM Warszawa Mazowieckie

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain intensity according to Numerical Rating Scale (NRS) till 4cm cervical dilation in primigravida or 3cm multiparous up to 24 hours
Secondary Fetal heart rate till 4cm cervical dilation in primigravida or 3cm multiparous up to 24 hours
Secondary Blood pressure parturient till 4cm cervical dilation in primigravida or 3cm multiparous up to 24 hours
Secondary Heart rate of parturient till 4cm cervical dilation in primigravida or 3cm multiparous up to 24 hours
See also
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Completed NCT02550262 - Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor N/A
Completed NCT01598506 - Intrathecal Hydromorphone for Labor Analgesia Phase 2
Withdrawn NCT01636999 - Comparing Sedara to Butorphanol in Early Labor N/A
Completed NCT00987441 - Epidural Labor Analgesia and Infant Neurobehavior N/A
Completed NCT00755092 - Effect of Doula in Nulliparas and Multiparas N/A
Terminated NCT00787176 - The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes N/A
Recruiting NCT06036797 - Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia Phase 2
Completed NCT05512065 - Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women N/A
Completed NCT05327088 - Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia Phase 2
Completed NCT03103100 - Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation Phase 3
Recruiting NCT03623256 - Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia Phase 4
Active, not recruiting NCT02271100 - Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique N/A
Completed NCT02926469 - Virtual Reality Analgesia in Labor: The VRAIL Pilot Study N/A
Completed NCT03712735 - Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women Phase 4
Not yet recruiting NCT05565274 - Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients N/A
Recruiting NCT01708668 - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia N/A
Recruiting NCT02575677 - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety