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

Epidural Analgesia Clinical Trial

— AOMHE  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03314571
• Other study ID #: CHU-357
• Secondary ID: 2017-A00814-49
• Status: Not yet recruiting
• Phase: N/A
• First received: October 16, 2017
• Last updated: November 7, 2017
• Start date: November 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epidural Analgesia
• Hospital Follow-up
• Labor Pain

Intervention

Other:
• analgesia for labor
A prospective database to study the determinants of labor pain and the resulting maternal non satisfaction.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from the morning of day 2 postpartum to the morning of day 3 postpartum.
Secondary	Wish for a similar analgesia for future labor.		from the morning of day 2 postpartum to the morning of day 3 postpartum.
Secondary	Qualitative maternal concerns about analgesia for labor	verbatim (free field).	from the morning of day 2 postpartum to the morning of day 3 postpartum