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

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ClinicalTrials.gov Identifier: NCT02824302
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Labor Pain Other: Survey

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

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Evaluate Efficacy of Simple Questions to Predict Labor Pain and Epidural Analgesia Use in Parturients
Actual Study Start Date : July 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Survey
    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.


Primary Outcome Measures :
  1. Area Under the Curve (AUC) [ Time Frame: 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 :
  1. Time from onset of labor to epidural analgesia [ Time Frame: minutes > 30 minutes ]
  2. Cervical dilatation at the time of request(cm) [ Time Frame: hours (>1 hour) ]
  3. Pain score at the time of request of labor analgesia [ Time Frame: VAS (1-10) ]
  4. Duration labor [ Time Frame: hours (> 1 hour) ]
  5. Number of epidural boluses [ Time Frame: hours (> 1 hour) ]
  6. Patient comfort during labor (1-5) [ Time Frame: hours (>1 hour) ]
  7. Pain VAS during Epidural insertion (0-10) [ Time Frame: hours (> 1 hour) ]
  8. Patient satisfaction with epidural analgesia [ Time Frame: hours ( >1 hour) ]
  9. Mode of delivery [ Time Frame: hours (>1 hour) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Healthy full term pregnant patients with singleton pregnancy
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824302


Locations
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Canada, Ontario
London Health Science Centre
London, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
Publications of Results:
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02824302    
Other Study ID Numbers: 107817
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations