Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum (PERIDEAMBU)

Centre Hospitalier Régional Metz-Thionville

Status: Enrolling

Conditions: Childbirth; Epidural; Anesthesia

Treatments: Behavioral: QEVA questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT06550570

2024-02Obs-CHRMT

Details and patient eligibility

About

Childbirth is a special event for women. Maternal satisfaction regarding childbirth is quite important, that is why this factor has to be taken into account. A bad experience related to childbirth could lead to serious psychological and organic consequences such as postpartum depression, mother-baby bond deterioration and chronic pelvic pain. Childbirth image changed over the years to the extent that an increasingly physiological process keeping analgesia and safety is more and more desired. In this perspective, this study aims to investigate an approach so-called ambulatory epidural. Indeed, only a few studies have been conducted and the ones published in 1990s did not involve the current recommended pharmacological protocols.

Full description

This is a multi-centre prospective observational analytical before/after-type study.

Practice changes are planned in concerned departments, in particular regarding usual patient care. This observational study aims to quantify the impact of practice changes on patient experience using a Childbirth Assessment Questionnaire (QEVA). During the "before" period, patients will receive a conventional epidural while the others, during the "after" period, will receive an ambulatory epidural. The women involved into this study must fill the QEVA form 2 days after giving birth (at the maternity) then 4 weeks after giving birth in order to get a feedback related to postpartum feelings (phone call).

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women older than 18 years old
• with Physiological pregnancy (fetus cephalic position, normal fetal heart rate, spontaneous work between 37 and 41 SA)
• Having benefited from epidural, usual or ambulatory depending on the study period
• who speeks and understand French
• who signed a free and informed consent form

Exclusion criteria

• Hearing or comprehension impairment
• Twin pregnancies
• Scarred uterus
• Fetus in non cephalic position
• Imminent delivery
• Women under protective supervision (guardianship, curatorship)
• Women bereaved of a spouse or child during pregnancy
• Hospitalization of child in neonatology after delivery
• Women hospitalized in critical care units after childbirth

Trial design

500 participants in 2 patient groups

Conventional epidural anesthesia (=before revision of the usual practice of the maternity ward)

Description:

A local anesthetic and an opioid are administered into the epidural space, as per department protocol (usual practice).

Treatment:

Behavioral: QEVA questionnaire

Ambulatory epidural anesthesia (=after revision of the usual practice of the maternity ward)

Description:

Low doses of local anesthetic and an opioid are administered into the epidural space to allow the patient to walk around while being monitored, as per department revised protocol (usual practice)

Treatment:

Behavioral: QEVA questionnaire