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

NCT ID: NCT06550570

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-23

Study Completion Date

2025-08-23

Brief Summary

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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

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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).

Conditions

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Childbirth Epidural; Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

QEVA questionnaire

Intervention Type BEHAVIORAL

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

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

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)

QEVA questionnaire

Intervention Type BEHAVIORAL

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

Interventions

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QEVA questionnaire

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa LEON, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz Thionville Hopital Femme Mère Enfant

Locations

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CHR Metz Thionville Hopital Femme Mère Enfant

Metz, , France

Site Status RECRUITING

CHR Metz-Thionville Hopital Mère Enfant

Thionville, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Arpiné EL NAR, PhD

Role: CONTACT

0033387557766

Facility Contacts

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Arpiné EL NAR, PhD

Role: primary

0033387557766

Arpiné EL NAR, PhD

Role: primary

0033387557766

Other Identifiers

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2024-02Obs-CHRMT

Identifier Type: -

Identifier Source: org_study_id

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