the Effects of Epidural Fentanyl on Vaginal Delivery (EFVD)

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Bishop Score; Duration of Delivery; Cervical Dilatation

Treatments: Drug: Fentanyl; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02135224

M79

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Fentanyl

Active Comparator group

Description:

20 microgram per hour

Treatment:

Drug: Fentanyl

Normal saline

Placebo Comparator group

Description:

0.4 ml per hour

Treatment:

Drug: Normal saline