Clinical trial NCT06550570: Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum
Official title: Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childbirth
Epidural; Anesthesia
Keywords: Maternal satisfaction
ambulatory epidural
physiology
analgesia
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 500
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: Pregnant women willing to give birth at CHR Metz/Thionville (maternity)

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).

Eligibility criteria: 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

Primary outcomes:
measure: Obstetrical labor and delivery experience in birthgiving women
timeFrame: at 2 days postpartum
Secondary outcomes:
measure: Relations with nursing staff and first moments with the child
timeFrame: at 2 days postpartum
measure: Obstetrical labor and delivery experience in birthgiving women
timeFrame: at 4 weeks postpartum
measure: Labor and delivery safety : time spent in the delivery room
timeFrame: at 2 days postpartum
measure: Labor and delivery safety: need for instrumental extraction
timeFrame: at 2 days postpartum
measure: Labor and delivery safety : emergency caesarean sections
timeFrame: at 2 days postpartum
measure: Labor and delivery safety: ability to maintain spontaneous micturition
timeFrame: at 2 days postpartum
measure: Safety of ambulation
timeFrame: at 2 days postpartum
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville Hopital Femme Mère Enfant
city: Thionville
country: France
facility: CHR Metz-Thionville Hopital Mère Enfant
Study officials:
affiliation: CHR Metz Thionville Hopital Femme Mère Enfant
name: Lisa LEON, MD
role: PRINCIPAL_INVESTIGATOR
References: