Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

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Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter.

Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal.

This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.

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Detailed Description

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Terbutaline

Terbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN

Group Type EXPERIMENTAL

Terbutaline

Intervention Type DRUG

Fentanyl

Fentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Placebo

0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN

Group Type PLACEBO_COMPARATOR

0.9% NaCl

Intervention Type DRUG

Interventions

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Terbutaline

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

0.9% NaCl

Intervention Type DRUG

Other Intervention Names

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normal saline

Eligibility Criteria

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Inclusion Criteria

* in labor
* labor pain \>3 on visual analog scale (VAS)

Exclusion Criteria

* cardiovascular disease
* preeclampsia
* diabetes mel-litus
* thyroid disease
* current (outpatient) opioid medication
* recent and / or current use of cocaine
* seizure disorder
* psychiatric disease
* body mass index \>35
* preterm labor (\<37 weeks pregnant)
* known allergies to any of the three study substances

Minimum Eligible Age

18 Years

Maximum Eligible Age

53 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No