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Status unknownNCT03314571AOMHEUpdated Nov 9, 2017

Obstetrical Analgesia in the Estaing Hospital Maternity. A Prospective Database to Study the Determinants of Labor Pain and the Resulting Maternal Non Satisfaction.

An observational study in Epidural Analgesia and Hospital Follow-up, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-09.

Sponsored by University Hospital, Clermont-Ferrand · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
Female
01

Study summary

There is a trend to offer personalized care in many medical domains. In the field of labor pain, it appears that maternal satisfaction about care is multifactorial, and that labor pain is only one of its determinants, competing with psychological and sociological factors. Furthermore, labor pain is also multifactorial, depending on predisposition to pain, the way analgesia is conducted, and other environmental factors. We wish to develop predicting models of maternal satisfaction, in order to offer in the future a better tailored analgesia.

Read the detailed description

The observation shall be conducted at 3 major points of measurement throughout labor:

  1. Pre-, i.e. at the systematic visit for anesthesia, during the 3rd trimester of pregnancy. The collected variables will be: demographic, morphometric, socioeconomic, psychometric. The latter shall consist in a short questionnaire-based assessment by: Hospital Anxiety and Depression Scale, 5-points Mental Health Inventory, Life Orientation Scale. As soon as it will be validated, a Pain Sensitivity Questionnaire shall be added.
  2. Intra-, i.e. clinical data from the anesthesia file: conduction of epidural analgesia, labor pain, drug consumption, obstetrical outcomes.
  3. Post-, i.e. maternal satisfaction assessed by a set of seven 11-point numerical rating scales at day2 post childbirth, along with a written short qualitative assessment.

Different multivariable statistical models shall be used to identify the patients profiles and the possible determinants of satisfaction: descriptive (factorial analyses) and inferential (GLM or longitudinal).

02

Conditions studied

  • Epidural Analgesia
  • Hospital Follow-up

Keywords

  • Epidural analgesia
  • Labor pain
  • Satisfaction
  • Care assessment
  • Psychometry
03

In context

Labor Pain

423 studies on the registry are indexed under Labor Pain; 74 are open to participants now.

This study's planned enrollment of 600 is above the median of 132 across 62 observational studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any parturient coming for her regular pre-partum anesthesia visit at the Estaing Hospital Maternity

Exclusion criteria

Exclusion Criteria:

  • Refusal of epidural analgesia at the time of the visit.
  • Participation refusal.
  • Inability to answer the pre- or post-partum questionnaires.
  • Any medical condition considered as a relevant exclusion criterion by the investigator.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • non applicable

    Other: analgesia for labor

Interventions

  • Otheranalgesia for labor

    A prospective database to study the determinants of labor pain and the resulting maternal non satisfaction.

06

What researchers measure

Primary outcomes

  1. Maternal satisfaction about analgesia for labor

    Eight-domain questionnaire designed for the purpose of the study, each domain being addressed by an 11-point numerical scale from 0 (not satisfied at all) to 10 (totally satisfied). The 8 domains are: general analgesia care, rapidity of analgesia, pain control at expulsion, mobility during labor, self-control of labor, caregivers' attention, pain at epidural puncture, information about epidural.

    Time frame: from the morning of day 2 postpartum to the morning of day 3 postpartum.

Secondary outcomes

  1. Wish for a similar analgesia for future labor.

    Time frame: from the morning of day 2 postpartum to the morning of day 3 postpartum.

  2. Qualitative maternal concerns about analgesia for labor

    verbatim (free field).

    Time frame: from the morning of day 2 postpartum to the morning of day 3 postpartum

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2017; primary completion for Dec 2020, 37 months later.

Of 30 non-industry observational studies under Labor Pain, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 32. This study's planned 37 months is above that.

Counting every sponsor, half of 31 studies reached it within 9 months; a quarter within 6 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2017
First posted
Oct 19, 2017
StartEst.
Nov 2017
Primary completionEst.
Dec 31, 2020
CompletionEst.
Dec 31, 2020
Last update
Nov 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03314571
Responsible party
Sponsor
First posted
Oct 19, 2017
Start date
Nov 2017 (estimated)
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Nov 9, 2017

Study contacts

Patrick LACARIN
Contact
placarin@chu-clermontferrand.fr
04 73 75 11 95
Brigitte STORME
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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