AzTrials
AzTrials

Labor PainNCT02824302

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

An observational study of Labor Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Labor Pain
What is being tested?
Survey
How many people
50 participants
Where
1 siteCanada
Study dates
Jul 2016to May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Healthy full term pregnant patients with singleton pregnancy

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Science Centre

    London, Ontario

Other trials in Canada

About this study

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

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.

Read the 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

Conditions
Labor Pain
Being tested
Survey
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurveyOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Curve (AUC)

    this outcome will be measured at day 1 of delivery

    Measured: this outcome will measure the pain scores during labour from the start of epidural insertion until its discontinued.

Secondary outcomes (9)

  1. Time from onset of labor to epidural analgesia

    Measured: minutes > 30 minutes

  2. Cervical dilatation at the time of request(cm)

    Measured: hours (>1 hour)

  3. Pain score at the time of request of labor analgesia

    Measured: VAS (1-10)

  4. Duration labor

    Measured: hours (> 1 hour)

  5. Number of epidural boluses

    Measured: hours (> 1 hour)

  6. Patient comfort during labor (1-5)

    Measured: hours (>1 hour)

  7. Pain VAS during Epidural insertion (0-10)

    Measured: hours (> 1 hour)

  8. Patient satisfaction with epidural analgesia

    Measured: hours ( >1 hour)

  9. Mode of delivery

    Measured: hours (>1 hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionApr 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02824302
Sponsor's protocol ID
107817
Status last verified
Dec 2018
First submitted
13 May 2016
Last updated
11 Dec 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Pan PH, Tonidandel AM, Aschenbrenner CA, Houle TT, Harris LC, Eisenach JC. Predicting acute pain after cesarean delivery using three simple questions. Anesthesiology. 2013 May;118(5):1170-9. doi: 10.1097/ALN.0b013e31828e156f.

    PubMed 23485992

  • Carvalho B, Zheng M, Harter S, Sultan P. A Prospective Cohort Study Evaluating the Ability of Anticipated Pain, Perceived Analgesic Needs, and Psychological Traits to Predict Pain and Analgesic Usage following Cesarean Delivery. Anesthesiol Res Pract. 2016;2016:7948412. doi: 10.1155/2016/7948412. Epub 2016 Apr 7.

    PubMed 27143966

  • Carvalho B, Zheng M, Aiono-Le Tagaloa L. A prospective observational study evaluating the ability of prelabor psychological tests to predict labor pain, epidural analgesic consumption, and maternal satisfaction. Anesth Analg. 2014 Sep;119(3):632-640. doi: 10.1213/ANE.0000000000000357.

    PubMed 25029661

Questions about this trial

What is this clinical trial studying?

An observational study of Labor Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02824302, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in