Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum
- Conditions
- Epidural; AnesthesiaChildbirth
- Interventions
- Behavioral: QEVA questionnaire
- Registration Number
- NCT06550570
- Lead Sponsor
- Centre Hospitalier Régional Metz-Thionville
- Brief Summary
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.
- Detailed 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ambulatory epidural anesthesia (=after revision of the usual practice of the maternity ward) QEVA questionnaire 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) Conventional epidural anesthesia (=before revision of the usual practice of the maternity ward) QEVA questionnaire A local anesthetic and an opioid are administered into the epidural space, as per department protocol (usual practice).
- Primary Outcome Measures
Name Time Method Obstetrical labor and delivery experience in birthgiving women at 2 days postpartum The "emotional state" dimension of the Childbirth Assessment Questionnaire (QEVA) will be evaluated.
This questionnaire is written and validated in French. It contains 26 questions covering 4 dimensions: emotional state, relations with nursing staff, first moments with the baby, and the young mother's feelings one month before delivery.
- Secondary Outcome Measures
Name Time Method Obstetrical labor and delivery experience in birthgiving women at 4 weeks postpartum " emotional state " dimension of the Childbirth Assessment Questionnaire (QEVA)
Labor and delivery safety : emergency caesarean sections at 2 days postpartum Emergency caesarean sections (yes/no),
Labor and delivery safety: need for instrumental extraction at 2 days postpartum Need for instrumental extraction (yes/no)
Labor and delivery safety : time spent in the delivery room at 2 days postpartum Time spent in the delivery room (min)
Relations with nursing staff and first moments with the child at 2 days postpartum Other dimensions and isolated items of the QEVA questionnaire
Labor and delivery safety: ability to maintain spontaneous micturition at 2 days postpartum Ability to maintain spontaneous micturition (yes/no)
Safety of ambulation at 2 days postpartum absence of the following events : motor block, hypotension, malaise, falls, difficulty in achieving ambulation
Trial Locations
- Locations (2)
CHR Metz Thionville Hopital Femme Mère Enfant
🇫🇷Metz, France
CHR Metz-Thionville Hopital Mère Enfant
🇫🇷Thionville, France