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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Epidural Analgesia; Hospital Follow-up

Treatments: Other: analgesia for labor

Study type: Observational

Funder types: Other

Identifiers

NCT03314571

2017-A00814-49 (Other Identifier)

CHU-357

Details and patient eligibility

About

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.

Full 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).

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

non applicable

Treatment:

Other: analgesia for labor