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Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery

Primary Purpose

Labor Pain, Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
regional analgesia for labor
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • parturients requiring regional labor analgesia
  • dilation less than 5cm

Exclusion Criteria:

  • contraindication for regional technique
  • refuse to participate
  • language barriers
  • obesity
  • no pain

Sites / Locations

  • Aretaieio Hospital, University of AthensRecruiting
  • Aretaieio HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

epidural

combined

dural puncture epidural

Arm Description

Outcomes

Primary Outcome Measures

analgesic consumption
the amount of local anesthetic and opioid that required during labor

Secondary Outcome Measures

pain intensity on a numerical rating scale (minimum=0, maximum=10)
pain intensity
duration of labor
duration of first stage
satisfaction on a numerical rating scale (minimum=0, maximum=10)
satisfaction of parturients

Full Information

First Posted
January 19, 2020
Last Updated
March 4, 2020
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT04290702
Brief Title
Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery
Official Title
The Effect of Epidural, Combined and Dural Puncture Labor Epidural on Pain, Analgesics and Course of Vaginal Delivery: Randomised, Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 groups with different regional analgesic technique
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
epidural
Arm Type
Active Comparator
Arm Title
combined
Arm Type
Active Comparator
Arm Title
dural puncture epidural
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
regional analgesia for labor
Intervention Description
three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia
Primary Outcome Measure Information:
Title
analgesic consumption
Description
the amount of local anesthetic and opioid that required during labor
Time Frame
during the procedure/delivery
Secondary Outcome Measure Information:
Title
pain intensity on a numerical rating scale (minimum=0, maximum=10)
Description
pain intensity
Time Frame
during the procedure/delivery
Title
duration of labor
Description
duration of first stage
Time Frame
until delivery
Title
satisfaction on a numerical rating scale (minimum=0, maximum=10)
Description
satisfaction of parturients
Time Frame
during the procedure/delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: parturients requiring regional labor analgesia dilation less than 5cm Exclusion Criteria: contraindication for regional technique refuse to participate language barriers obesity no pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chyrssoula Staikou, Assoc Prof
Phone
00302107780172
Email
c_staikou@yahoo.gr
Facility Information:
Facility Name
Aretaieio Hospital, University of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chryssoula V Staikou, MD
Phone
+210 7286172
Email
c_staikou@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Chryssoula V Staikou, MD, DESA
Facility Name
Aretaieio Hospital
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chryssoula V Staikou, Assoc Prof

12. IPD Sharing Statement

Learn more about this trial

Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery

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