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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.

NCT ID: NCT03314571

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-30

Study Completion Date

2020-12-31

Brief Summary

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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

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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).

Conditions

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Epidural Analgesia Hospital Follow-up

Keywords

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Epidural analgesia Labor pain Satisfaction Care assessment Psychometry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non applicable

analgesia for labor

Intervention Type OTHER

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

Interventions

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analgesia for labor

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brigitte STORME

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

Phone: 04 73 75 11 95

Email: [email protected]

Facility Contacts

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Patrick LACARIN

Role: primary

Other Identifiers

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2017-A00814-49

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-357

Identifier Type: -

Identifier Source: org_study_id