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

NCT ID: NCT04290702

Last Updated: 2020-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-26

Study Completion Date

2021-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Labor Pain Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 groups with different regional analgesic technique
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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epidural

Group Type ACTIVE_COMPARATOR

regional analgesia for labor

Intervention Type PROCEDURE

three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia

combined

Group Type ACTIVE_COMPARATOR

regional analgesia for labor

Intervention Type PROCEDURE

three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia

dural puncture epidural

Group Type ACTIVE_COMPARATOR

regional analgesia for labor

Intervention Type PROCEDURE

three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia

Interventions

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regional analgesia for labor

three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Staikou Chryssoula

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aretaieio Hospital, University of Athens

Athens, Attica, Greece

Site Status RECRUITING

Aretaieio Hospital

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Chyrssoula Staikou, Assoc Prof

Role: CONTACT

00302107780172

Facility Contacts

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Chryssoula V Staikou, MD

Role: primary

+210 7286172

Chryssoula V Staikou, Assoc Prof

Role: primary

Other Identifiers

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155/19-12-19

Identifier Type: -

Identifier Source: org_study_id

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