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the Effects of Epidural Fentanyl on Vaginal Delivery (EFVD)

Primary Purpose

Cervical Dilatation, Bishop Score, Duration of Delivery

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Fentanyl
Normal saline
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cervical Dilatation

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Aretaieio Hospital, University of AthensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fentanyl

Normal saline

Arm Description

20 microgram per hour

0.4 ml per hour

Outcomes

Primary Outcome Measures

cervical dilatation

Secondary Outcome Measures

Bishop score based on Cervical Position, Effacement, Dilation, Softness and Fetal Station.
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.

Full Information

First Posted
May 6, 2014
Last Updated
May 7, 2014
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT02135224
Brief Title
the Effects of Epidural Fentanyl on Vaginal Delivery
Acronym
EFVD
Official Title
The Effects of Fentanyl Added to Ropivacaine for Labour Epidural Analgesia on the Progress, Duration or Mode of Delivery: a Randomized, Double Blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dilatation, Bishop Score, Duration of Delivery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
20 microgram per hour
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
0.4 ml per hour
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Type
Drug
Intervention Name(s)
Normal saline
Primary Outcome Measure Information:
Title
cervical dilatation
Time Frame
every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm
Secondary Outcome Measure Information:
Title
Bishop score based on Cervical Position, Effacement, Dilation, Softness and Fetal Station.
Description
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.
Time Frame
every 60 min from the time the first epidural dose is administered up to delivery
Other Pre-specified Outcome Measures:
Title
duration of delivery
Time Frame
min between first epidural dose and delivery of the baby

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chryssoula V Staikou, PhD
Phone
00302107286000
Ext
195
Email
c_staikou@yahoo.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chryssoula Staikou, PhD
Organizational Affiliation
University of Athens
Official's Role
Principal Investigator
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 Staikou
Email
c_staikou@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Anteia Paraskeva, PhD

12. IPD Sharing Statement

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the Effects of Epidural Fentanyl on Vaginal Delivery

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