3 Simple Questions to Predict Labor Pain and Epidural Analgesia Use in Parturients

Completed

• Conditions: Labor Pain

• Registration Number: NCT02824302
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

Labor pain is complex to understand and challenging to define because of the interaction of multiple maternal and fetal factors. Poorly controlled acute post-procedural pain may result in harmful physiological and psychological consequences for both mother and baby. It is therefore important to understand the prelabor factors that may affect the labour pain to facilitate the intrapartum pain management. The goal of this prospective observational study is to verify if expectations regarding pain experience translate to actual pain outcomes for women who are undergoing induction of labor.

Detailed Description

A prospective observational cohort study. 100 parturients having induction of labor that match inclusion criteria will be asked to participate. After written informed consent, vital signs and patient demographics will be obtained and recorded. A 3 question survey will be given. Patients will be asked to rate, using a 0-10 cm visual analog scale (VAS), their anxiety level ("On a scale of 0-10 cm, with 0 being not anxious at all through 10 being extremely anxious, how anxious are you about your upcoming labor and delivery?"), their anticipated pain ("On a scale of 0-10, with 0 being no pain at all and 10 being pain as bad as you can imagine, how much pain do you anticipate experiencing during your upcoming labor and delivery?"), and using a categorical scale, to rate their anticipated epidural analgesic need ("On a scale of 0-5, with 0 being none at all, 1 being much less than average, 2 being less than average, 3 being average, 4 being more than average, and 5 being much more than average, how much epidural pain medication do you anticipate needing during your upcoming labor and delivery?"). Then 24 hours after delivery, patient VAS scores will be recorded, number of boluses, total number of hours of labor, patient comfort level and satisfaction

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-06-30
• Study Start: 2016-07
• Study First Posted: 2016-07-06
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC)	this outcome will measure the pain scores during labour from the start of epidural insertion until its discontinued.	this outcome will be measured at day 1 of delivery

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with epidural analgesia	hours ( >1 hour)
Patient comfort during labor (1-5)	hours (>1 hour)
Cervical dilatation at the time of request(cm)	hours (>1 hour)
Duration labor	hours (> 1 hour)
Number of epidural boluses	hours (> 1 hour)
Mode of delivery	hours (>1 hour)
Time from onset of labor to epidural analgesia	minutes > 30 minutes
Pain score at the time of request of labor analgesia	VAS (1-10)
Pain VAS during Epidural insertion (0-10)	hours (> 1 hour)

Trial Locations

Locations (1)

London Health Science Centre; 🇨🇦 London, Ontario, Canada