Clinical trial NCT03314571: Obstetrical Analgesia in the Estaing Hospital Maternity. A Prospective Database to Study the Determinants of Labor Pain and the Resulting Maternal Non Satisfaction.
Official title: Obstetrical Analgesia in the Estaing Hospital Maternity. A Prospective Database to Study the Determinants of Labor Pain and the Resulting Maternal Non Satisfaction.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epidural Analgesia
Hospital Follow-up
Keywords: Epidural analgesia
Labor pain
Satisfaction
Care assessment
Psychometry
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal satisfaction about analgesia for labor
timeFrame: from the morning of day 2 postpartum to the morning of day 3 postpartum.
Secondary outcomes:
measure: Wish for a similar analgesia for future labor.
timeFrame: from the morning of day 2 postpartum to the morning of day 3 postpartum.
measure: Qualitative maternal concerns about analgesia for labor
timeFrame: from the morning of day 2 postpartum to the morning of day 3 postpartum
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Brigitte STORME
role: PRINCIPAL_INVESTIGATOR
References: