Skip to content

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

A Prospective Observational Study to Evaluate Efficacy of Simple Questions to Predict Labor Pain and Epidural Analgesia Use in Parturients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02824302
Enrollment
50
Registered
2016-07-06
Start date
2016-07-31
Completion date
2017-05-31
Last updated
2018-12-11

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

Conditions

Labor Pain

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

Interventions

OTHERSurvey

Patients coming for induction of labor will be handed a survey regarding their expectation of their coming labor pain. And then will be followed up after 24 hours of their delivery.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

1. The patient is 18 years or older 2. ASA class II or III according to the 2014 American Society of Anesthesiologists' physical status classification 3. The patient is having induction of labor 4. The patient is having a singleton pregnancy 5. the fetus's gestational age is more than 37 weeks 6. the patient is considering having epidural analgesia.

Exclusion criteria

1. The patient has refused to participate 2. There is a language barrier between the patient and the investigator 3. The patient received narcotics within the last two hours 4. the patient has chronic pain issues 5. There is significant concern about maternal or fetal welfare 6. The patient has a history of opioid tolerance 7. The patient has major psychiatric problem, 8. There is contraindication to epidural labor analgesia 9. Patient has allergy to local anesthetics.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frame
Cervical dilatation at the time of request(cm)hours (>1 hour)
Pain score at the time of request of labor analgesiaVAS (1-10)
Duration laborhours (> 1 hour)
Number of epidural boluseshours (> 1 hour)
Time from onset of labor to epidural analgesiaminutes > 30 minutes
Pain VAS during Epidural insertion (0-10)hours (> 1 hour)
Patient satisfaction with epidural analgesiahours ( >1 hour)
Mode of deliveryhours (>1 hour)
Patient comfort during labor (1-5)hours (>1 hour)

Countries

Canada

Outcome results

None listed

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