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

NCT06550570 | Recruiting

• 1 other identifier: 2024-02Obs-CHRMT
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 2

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.

Conditions

Childbirth; Epidural; Anesthesia

Keywords

Maternal satisfaction; ambulatory epidural; physiology; analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Relations with nursing staff and first moments with the child

  at 2 days postpartum

• Obstetrical labor and delivery experience in birthgiving women

  at 4 weeks postpartum

• Labor and delivery safety : time spent in the delivery room

  at 2 days postpartum

• Labor and delivery safety: need for instrumental extraction

  at 2 days postpartum

• Labor and delivery safety : emergency caesarean sections

  at 2 days postpartum

Study Arms (2)

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

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Birthgiving women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (2)

CHR Metz Thionville Hopital Femme Mère Enfant

Metz, 57085, France

RECRUITING

CHR Metz-Thionville Hopital Mère Enfant

Thionville, 57100, France

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa LEON, MD

  CHR Metz Thionville Hopital Femme Mère Enfant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 13, 2024
• Study Start: July 23, 2024
• Primary Completion: July 23, 2025
• Study Completion: August 23, 2025
• Last Updated: July 4, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)