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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03314571
Acronym
AOMHE
Enrollment
600
Registered
2017-10-19
Start date
2017-11-30
Completion date
2020-12-31
Last updated
2017-11-09

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

Conditions

Epidural Analgesia, Hospital Follow-up

Keywords

Epidural analgesia, Labor pain, Satisfaction, Care assessment, Psychometry

Brief 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.

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).

Interventions

OTHERanalgesia for labor

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Maternal satisfaction about analgesia for laborfrom the morning of day 2 postpartum to the morning of day 3 postpartum.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.

Secondary

MeasureTime frameDescription
Wish for a similar analgesia for future labor.from the morning of day 2 postpartum to the morning of day 3 postpartum.
Qualitative maternal concerns about analgesia for laborfrom the morning of day 2 postpartum to the morning of day 3 postpartumverbatim (free field).

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

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