the Effects of Epidural Fentanyl on Vaginal Delivery (EFVD)

May 7, 2014 updated by: Staikou Chryssoula, University of Athens

The Effects of Fentanyl Added to Ropivacaine for Labour Epidural Analgesia on the Progress, Duration or Mode of Delivery: a Randomized, Double Blind Study.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11528
        • Recruiting
        • Aretaieio Hospital, University of Athens
        • Contact:
        • Sub-Investigator:
          • Anteia Paraskeva, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fentanyl
20 microgram per hour
Drug: Fentanyl
Placebo Comparator: Normal saline
0.4 ml per hour
Drug: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cervical dilatation
Time Frame: every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm
every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bishop score based on Cervical Position, Effacement, Dilation, Softness and Fetal Station.
Time Frame: every 60 min from the time the first epidural dose is administered up to delivery
Bishop score is a pre-labor scoring system which reflects the stage of the procedure (mainly the cervix condition) assessing the following: Cervical Position, Effacement, Dilation, Softness and also Fetal Station.
every 60 min from the time the first epidural dose is administered up to delivery

Other Outcome Measures

Outcome Measure
Time Frame
duration of delivery
Time Frame: min between first epidural dose and delivery of the baby
min between first epidural dose and delivery of the baby

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Investigators

  • Principal Investigator: Chryssoula Staikou, PhD, University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M79

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bishop Score

Clinical Trials on Fentanyl

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe