the Effects of Epidural Fentanyl on Vaginal Delivery

NCT ID: NCT02135224

Last Updated: 2014-05-09

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Brief Summary

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The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and possibly result in a shorter duration of vaginal delivery.

Detailed Description

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Conditions

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Cervical Dilatation Bishop Score Duration of Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fentanyl

20 microgram per hour

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Normal saline

0.4 ml per hour

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Interventions

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Fentanyl

Intervention Type DRUG

Normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anaesthesiologists physical status I or II
* nulliparous
* normal singleton uncomplicated pregnancies of more than 38 weeks
* cephalic presentation of the fetus
* anticipated vaginal delivery
* active stage of labour
* cervical dilatation between 3-5 cm
* regular uterine contractions
* normal cardiotocographic recordings.

Exclusion Criteria

* medical problems during pregnancy
* BMI≥40 kg m-2
* opioid allergy
* prior administration of opioids or other analgesics
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 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

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chryssoula Staikou, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Athens

Locations

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Aretaieio Hospital, University of Athens

Athens, Attica, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Chryssoula V Staikou, PhD

Role: CONTACT

00302107286000 ext. 195

Facility Contacts

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Chryssoula Staikou

Role: primary

Other Identifiers

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M79

Identifier Type: -

Identifier Source: org_study_id

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