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

Primary Purpose

Anesthesia, Epidural, Opioid, Labor Pain

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Fentanyl
Sufentanil
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Epidural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Uniwersyteckie Centrum Zdrowia Kobiety i Noworodka, WUMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Fentanyl

Sufentanyl

Control

Arm Description

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

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

No epidural analgesia

Outcomes

Primary Outcome Measures

Pain intensity according to Numerical Rating Scale (NRS)
till 4cm cervical dilation in primigravida or 3cm multiparous

Secondary Outcome Measures

Fetal heart rate
till 4cm cervical dilation in primigravida or 3cm multiparous
Blood pressure parturient
till 4cm cervical dilation in primigravida or 3cm multiparous
Heart rate of parturient
till 4cm cervical dilation in primigravida or 3cm multiparous

Full Information

First Posted
August 16, 2017
Last Updated
December 5, 2018
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT03344042
Brief Title
Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour
Official Title
Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 20, 2018 (Anticipated)
Study Completion Date
December 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Epidural, Opioid, Labor Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participant not aware of opioid administered
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
100mcg Fentanyl administered into epidural space during regular contractions before cervical dilation
Arm Title
Sufentanyl
Arm Type
Active Comparator
Arm Description
10mcg sufentanyl administered into the epidural space during regular contractions before cervical dilation
Arm Title
Control
Arm Type
No Intervention
Arm Description
No epidural analgesia
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
100mcg Fentanyl
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
10mcg sufentanil
Primary Outcome Measure Information:
Title
Pain intensity according to Numerical Rating Scale (NRS)
Description
till 4cm cervical dilation in primigravida or 3cm multiparous
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Fetal heart rate
Description
till 4cm cervical dilation in primigravida or 3cm multiparous
Time Frame
up to 24 hours
Title
Blood pressure parturient
Description
till 4cm cervical dilation in primigravida or 3cm multiparous
Time Frame
up to 24 hours
Title
Heart rate of parturient
Description
till 4cm cervical dilation in primigravida or 3cm multiparous
Time Frame
up to 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Bilawicz, MD
Phone
0048225830381
Email
bilawicz@wp.pl
Facility Information:
Facility Name
Uniwersyteckie Centrum Zdrowia Kobiety i Noworodka, WUM
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-015
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Bilawicz, MD
Phone
0048 22 583 03 81
Email
bilawicz@wp.pl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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