the Effects of Epidural Fentanyl on Vaginal Delivery
Not Applicable
- Conditions
- Cervical DilatationBishop ScoreDuration of Delivery
- Interventions
- Drug: Normal saline
- Registration Number
- NCT02135224
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fentanyl Fentanyl 20 microgram per hour Normal saline Normal saline 0.4 ml per hour
- Primary Outcome Measures
Name Time Method cervical dilatation every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (1)
Aretaieio Hospital, University of Athens
🇬🇷Athens, Attiki, Greece