the Effects of Epidural Fentanyl on Vaginal Delivery

University of Athens60 enrolled

Overview

The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and possibly result in a shorter duration of vaginal delivery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Cervical Dilatation Bishop Score Duration of Delivery

Interventions

FentanylDRUG

Normal salineDRUG

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Aretaieio Hospital, University of Athens

Athens, Attica, Greece

RECRUITING

Outcomes

Primary Outcomes

cervical dilatation

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

Secondary Outcomes

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.

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

Central Contacts

Chryssoula V Staikou, PhD

CONTACT

00302107286000 c_staikou@yahoo.gr

Data from ClinicalTrials.gov

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