NCT02135224

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

Enrollment Period

2.6 years

First QC Date

May 6, 2014

Last Update Submit

May 7, 2014

Conditions

Cervical DilatationBishop ScoreDuration of Delivery

Outcome Measures

Primary Outcomes (1)

  • cervical dilatation

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

Secondary Outcomes (1)

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

    every 60 min from the time the first epidural dose is administered up to delivery

Other Outcomes (1)

  • duration of delivery

    min between first epidural dose and delivery of the baby

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

20 microgram per hour

Drug: Fentanyl

Normal saline

PLACEBO COMPARATOR

0.4 ml per hour

Drug: Normal saline

Interventions

FentanylDRUG
Fentanyl
Normal salineDRUG
Normal saline

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieio Hospital, University of Athens

Athens, Attica, 11528, Greece

RECRUITING

MeSH Terms

Interventions

FentanylSaline Solution

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Chryssoula Staikou, PhD

    University of Athens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chryssoula V Staikou, PhD

CONTACT

00302107286000c_staikou@yahoo.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 9, 2014

Study Start

December 1, 2011

Primary Completion

July 1, 2014

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations

GR(1)