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the Effects of Epidural Fentanyl on Vaginal Delivery

The Effects of Fentanyl Added to Ropivacaine for Labour Epidural Analgesia on the Progress, Duration or Mode of Delivery: a Randomized, Double Blind Study.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02135224
Acronym
EFVD
Enrollment
60
Registered
2014-05-09
Start date
2011-12-31
Completion date
Unknown
Last updated
2014-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bishop Score, Cervical Dilatation, Duration of Delivery

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.

Interventions

DRUGFentanyl
DRUGNormal saline

Sponsors

University of Athens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
cervical dilatationevery 60 min starting from the first epidural dose up to cervical dilatation of 10 cm

Secondary

MeasureTime frameDescription
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 deliveryBishop 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

MeasureTime frame
duration of deliverymin between first epidural dose and delivery of the baby

Countries

Greece

Contacts

Primary ContactChryssoula V Staikou, PhD
c_staikou@yahoo.gr00302107286000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026