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

NCT ID: NCT03344042

Last Updated: 2018-12-06

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

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia, Epidural Opioid Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participant not aware of opioid administered

Study Groups

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Fentanyl

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

100mcg Fentanyl

Sufentanyl

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

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

10mcg sufentanil

Control

No epidural analgesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fentanyl

100mcg Fentanyl

Intervention Type DRUG

Sufentanil

10mcg sufentanil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Jan Biławicz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Uniwersyteckie Centrum Zdrowia Kobiety i Noworodka, WUM

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Jan Bilawicz, MD

Role: CONTACT

0048225830381

Facility Contacts

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Jan Bilawicz, MD

Role: primary

0048 22 583 03 81

Other Identifiers

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KB/46/2016

Identifier Type: -

Identifier Source: org_study_id

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