the Effects of Epidural Fentanyl on Vaginal Delivery | NCT02135224

Studies
the Effects of Epidural Fentanyl on Vaginal Delivery

NCT02135224

Sponsor

University of Athens

Status

Unknown status

Last Update Posted

May 9, 2014Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Cervical Dilatation
Bishop Score
Duration of Delivery

Interventions

Fentanyl
Normal saline

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jul 2014Estimated

Completion Date

Not provided

First Submitted Date

May 6, 2014

First Submission Date that Met QC Criteria

May 7, 2014

First Posted Date

May 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2014

Last Update Posted Date

May 9, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fentanyl	Active Comparator	20 microgram per hour	Drug: Fentanyl
Normal saline	Placebo Comparator	0.4 ml per hour	Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fentanyl	Drug		Fentanyl
Normal saline

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.	every 60 min from the time the first epidural dose is administered up to delivery

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chryssoula V Staikou, PhD	Contact	00302107286000	195	c_staikou@yahoo.gr

Overall Officials

Name	Affiliation	Role
Chryssoula Staikou, PhD	University of Athens	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aretaieio Hospital, University of Athens	Recruiting	Athens	Attica	11528	Greece

Type	Date	Date Unknown
Release	Oct 9, 2018
Reset	Feb 18, 2019
Release	Mar 24, 2020
Reset	Apr 6, 2020

Submission Tracking

Estimated Results First Submitted Date

Oct 9, 2018

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 9, 2018			Feb 18, 2019
Mar 24, 2020

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl
D000077330	Saline Solution

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000077324	Crystalloid Solutions

Browse Leaves

Not provided

Browse Branches

Not provided