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

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.

Study Overview

• Status: Recruiting
• Conditions: Epidural; Anesthesia; Childbirth
• Intervention / Treatment: Behavioral: QEVA questionnaire

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).

• Study Type: Observational
• Enrollment (Estimated): 126

Contacts and Locations

• Study Contact: Name: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr

Study Locations

• France
  • Metz, France, 57085
    • Recruiting
    • CHR Metz Thionville Hopital Femme Mère Enfant
    • Contact: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr
    • Principal Investigator: Lisa LEON, MD
  • Thionville, France, 57100
    • Recruiting
    • CHR Metz-Thionville Hopital Mère Enfant
    • Contact: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr
    • Principal Investigator: Mehdi HENRY, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women willing to give birth at CHR Metz/Thionville (maternity)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Behavioral: QEVA questionnaire; 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)	Behavioral: QEVA questionnaire; QEVA questionnaire administered at 2 days pospartum (in hospital) and 4 weeks postpartum (phone call). (specific for the study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstetrical labor and delivery experience in birthgiving women	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.	at 2 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relations with nursing staff and first moments with the child	Other dimensions and isolated items of the QEVA questionnaire	at 2 days postpartum
Obstetrical labor and delivery experience in birthgiving women	" emotional state " dimension of the Childbirth Assessment Questionnaire (QEVA)	at 4 weeks postpartum
Labor and delivery safety : time spent in the delivery room	Time spent in the delivery room (min)	at 2 days postpartum
Labor and delivery safety: need for instrumental extraction	Need for instrumental extraction (yes/no)	at 2 days postpartum
Labor and delivery safety : emergency caesarean sections	Emergency caesarean sections (yes/no),	at 2 days postpartum
Labor and delivery safety: ability to maintain spontaneous micturition	Ability to maintain spontaneous micturition (yes/no)	at 2 days postpartum
Safety of ambulation	absence of the following events : motor block, hypotension, malaise, falls, difficulty in achieving ambulation	at 2 days postpartum

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Lisa LEON, MD, CHR Metz Thionville Hopital Femme Mère Enfant

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Estimated): July 23, 2025
• Study Completion (Estimated): August 23, 2025

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: analgesia; physiology; Maternal satisfaction; ambulatory epidural
• Other Study ID Numbers: 2024-02Obs-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No