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NCT Number: NCT06550570

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

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.

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Key information

Conditions

Childbirth Agnosia Epidural; Anesthesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHR Metz Thionville Hopital Femme Mère Enfant, Metz, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QEVA questionnaire

Behavioral

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

Primary outcomes

  1. Obstetrical labor and delivery experience in birthgiving women

    Time frame: 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 outcomes

  1. Relations with nursing staff and first moments with the child

    Time frame: at 2 days postpartum

    Other dimensions and isolated items of the QEVA questionnaire

  2. Obstetrical labor and delivery experience in birthgiving women

    Time frame: at 4 weeks postpartum

    " emotional state " dimension of the Childbirth Assessment Questionnaire (QEVA)

  3. Labor and delivery safety : time spent in the delivery room

    Time frame: at 2 days postpartum

    Time spent in the delivery room (min)

  4. Labor and delivery safety: need for instrumental extraction

    Time frame: at 2 days postpartum

    Need for instrumental extraction (yes/no)

  5. Labor and delivery safety : emergency caesarean sections

    Time frame: at 2 days postpartum

    Emergency caesarean sections (yes/no),

  6. Labor and delivery safety: ability to maintain spontaneous micturition

    Time frame: at 2 days postpartum

    Ability to maintain spontaneous micturition (yes/no)

  7. Safety of ambulation

    Time frame: at 2 days postpartum

    absence of the following events : motor block, hypotension, malaise, falls, difficulty in achieving ambulation

Study contacts

Contact information is provided by the study sponsor or research team.

Arpiné EL NAR, PhD

CONTACT

[email protected]

0033387557766

Mélanie JUNKE

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Acronym: PERIDEAMBU

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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