Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2018
CompletedDecember 6, 2018
December 1, 2018
1.1 years
August 16, 2017
December 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity according to Numerical Rating Scale (NRS)
till 4cm cervical dilation in primigravida or 3cm multiparous
up to 24 hours
Secondary Outcomes (3)
Fetal heart rate
up to 24 hours
Blood pressure parturient
up to 24 hours
Heart rate of parturient
up to 24 hours
Study Arms (3)
Fentanyl
ACTIVE COMPARATOR100mcg Fentanyl administered into epidural space during regular contractions before cervical dilation
Sufentanyl
ACTIVE COMPARATOR10mcg sufentanyl administered into the epidural space during regular contractions before cervical dilation
Control
NO INTERVENTIONNo epidural analgesia
Interventions
Eligibility Criteria
You may qualify if:
- parturient in labour without cervical dilation and regular uterine contractions
You may not qualify if:
- no consent
- known allergy to administered opioid
- contraindications to epidural analgesia
- coagulopathies including platelet count of less than 100,000
- spine surgery in past
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uniwersyteckie Centrum Zdrowia Kobiety i Noworodka, WUM
Warsaw, Masovian Voivodeship, 02-015, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participant not aware of opioid administered
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 16, 2017
First Posted
November 17, 2017
Study Start
December 1, 2017
Primary Completion
December 20, 2018
Study Completion
December 20, 2018
Last Updated
December 6, 2018
Record last verified: 2018-12