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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

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.

Condition or disease Intervention/treatment Phase
Cervical Dilatation Bishop Score Duration of Delivery Drug: Fentanyl Drug: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : December 2011
Estimated Primary Completion Date : July 2014

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



Primary Outcome Measures :
  1. cervical dilatation [ Time Frame: every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm ]

Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. duration of delivery [ Time Frame: min between first epidural dose and delivery of the baby ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135224


Contacts
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Contact: Chryssoula V Staikou, PhD 00302107286000 ext 195 c_staikou@yahoo.gr

Locations
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Greece
Aretaieio Hospital, University of Athens Recruiting
Athens, Attiki, Greece, 11528
Contact: Chryssoula Staikou       c_staikou@yahoo.gr   
Sub-Investigator: Anteia Paraskeva, PhD         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Chryssoula Staikou, PhD University of Athens
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Responsible Party: Staikou Chryssoula, Assistant Professor, University of Athens
ClinicalTrials.gov Identifier: NCT02135224    
Other Study ID Numbers: M79
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Aneurysm
Dilatation, Pathologic
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics