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the Effects of Epidural Fentanyl on Vaginal Delivery (EFVD)

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ClinicalTrials.gov Identifier: NCT02135224
Recruitment Status : Unknown
Verified May 2014 by Staikou Chryssoula, University of Athens.
Recruitment status was:  Recruiting
First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Staikou Chryssoula, University of Athens

Tracking Information
First Submitted Date  ICMJE May 6, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date May 9, 2014
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
cervical dilatation [ Time Frame: every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 7, 2014)
duration of delivery [ Time Frame: min between first epidural dose and delivery of the baby ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE the Effects of Epidural Fentanyl on Vaginal Delivery
Official Title  ICMJE The Effects of Fentanyl Added to Ropivacaine for Labour Epidural Analgesia on the Progress, Duration or Mode of Delivery: a Randomized, Double Blind Study.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cervical Dilatation
  • Bishop Score
  • Duration of Delivery
Intervention  ICMJE
  • Drug: Fentanyl
  • Drug: Normal saline
Study Arms  ICMJE
  • Active Comparator: Fentanyl
    20 microgram per hour
    Intervention: Drug: Fentanyl
  • Placebo Comparator: Normal saline
    0.4 ml per hour
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 7, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135224
Other Study ID Numbers  ICMJE M79
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Staikou Chryssoula, University of Athens
Study Sponsor  ICMJE University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chryssoula Staikou, PhD University of Athens
PRS Account University of Athens
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP