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Recruiting NCT06550570

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

— Observational Childbirth Epidural; Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QEVA questionnaire.
Who it may be relevant to
Registry conditions: Childbirth, Epidural; Anesthesia. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Behavioral QEVA questionnaire
    QEVA questionnaire administered at 2 days pospartum (in hospital) and 4 weeks postpartum (phone call). (specific for the study)

Primary outcome measures

  • Obstetrical labor and delivery experience in birthgiving women [Time frame: at 2 days postpartum]
Secondary outcome measures (7)
  • Relations with nursing staff and first moments with the child [Time frame: at 2 days postpartum]
  • Obstetrical labor and delivery experience in birthgiving women [Time frame: at 4 weeks postpartum]
  • Labor and delivery safety : time spent in the delivery room [Time frame: at 2 days postpartum]
  • Labor and delivery safety: need for instrumental extraction [Time frame: at 2 days postpartum]
  • Labor and delivery safety : emergency caesarean sections [Time frame: at 2 days postpartum]
  • Labor and delivery safety: ability to maintain spontaneous micturition [Time frame: at 2 days postpartum]
  • Safety of ambulation [Time frame: at 2 days postpartum]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • CHR Metz Thionville Hopital Femme Mère Enfant — Metz
  • CHR Metz-Thionville Hopital Mère Enfant — Thionville

Identifiers

NCT: NCT06550570 · 2024-02Obs-CHRMT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗