the Effects of Epidural Fentanyl on Vaginal Delivery

Bishop Score Clinical Trial

— EFVD  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02135224
• Other study ID #: M79
• Status: Recruiting
• Phase: N/A
• First received: May 6, 2014
• Last updated: May 7, 2014
• Start date: December 2011

Study information

• Verified date: May 2014
• Source: University of Athens
• Contact: Chryssoula V Staikou, PhD
• Phone: 00302107286000
• Email: c_staikou[@]yahoo.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bishop Score
• Cervical Dilatation
• Duration of Delivery

Intervention

Drug:
• Fentanyl

• Normal saline

Locations

Country	Name	City	State
Greece	Aretaieio Hospital, University of Athens	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of delivery		min between first epidural dose and delivery of the baby	No
Primary	cervical dilatation		every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm	No
Secondary	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	No