ChildbirthPERIDEAMBUNCT06550570
Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum
An observational study of Childbirth and Epidural; Anesthesia, run by Centre Hospitalier Régional Metz-Thionville at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Childbirth, Epidural; Anesthesia
- What is being tested?
- QEVA questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 126 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Jul 2024to 23 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women willing to give birth at CHR Metz/Thionville (maternity)
Who may be able to join
- 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
Who cannot join
- Hearing or comprehension impairment
- Twin pregnancies
- Scarred uterus
- Fetus in non cephalic position
- Imminent delivery
- Women under protective supervision (guardianship, curatorship)
Show all 9Show fewer
- Women bereaved of a spouse or child during pregnancy
- Hospitalization of child in neonatology after delivery
- Women hospitalized in critical care units after childbirth
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mélanie JUNKE contact
France2 sites, 2 recruiting
- Recruiting
CHR Metz Thionville Hopital Femme Mère Enfant
Metz, 57085
Arpiné EL NAR, PhD, 0033387557766, projet-recherche-clinique@chr-metz-thionville.fr
Lisa LEON, MD
- Recruiting
CHR Metz-Thionville Hopital Mère Enfant
Thionville, 57100
Arpiné EL NAR, PhD, 0033387557766, projet-recherche-clinique@chr-metz-thionville.fr
Mehdi HENRY, MD
About this study
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.
Read the 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).
- Conditions
- Childbirth, Epidural; Anesthesia
- Being tested
- QEVA questionnaire
- Keywords
- Maternal satisfaction, ambulatory epidural, physiology, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QEVA questionnaireBehavioural
QEVA questionnaire administered at 2 days pospartum (in hospital) and 4 weeks postpartum (phone call). (specific for the study)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Behavioral: QEVA questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 2 days postpartum
Secondary outcomes (7)
Relations with nursing staff and first moments with the child
Other dimensions and isolated items of the QEVA questionnaire
Measured: at 2 days postpartum
Obstetrical labor and delivery experience in birthgiving women
" emotional state " dimension of the Childbirth Assessment Questionnaire (QEVA)
Measured: at 4 weeks postpartum
Labor and delivery safety : time spent in the delivery room
Time spent in the delivery room (min)
Measured: at 2 days postpartum
Labor and delivery safety: need for instrumental extraction
Need for instrumental extraction (yes/no)
Measured: at 2 days postpartum
Labor and delivery safety : emergency caesarean sections
Emergency caesarean sections (yes/no),
Measured: at 2 days postpartum
Labor and delivery safety: ability to maintain spontaneous micturition
Ability to maintain spontaneous micturition (yes/no)
Measured: at 2 days postpartum
Safety of ambulation
absence of the following events : motor block, hypotension, malaise, falls, difficulty in achieving ambulation
Measured: at 2 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start23 Jul 2024
- Primary completion23 Jul 2026 (estimated)
- Study completion23 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa LEON, MD, Principal investigator, CHR Metz Thionville Hopital Femme Mère Enfant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550570
- Sponsor's protocol ID
- 2024-02Obs-CHRMT
- Acronym
- PERIDEAMBU
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum
- ClinicalTrials.gov ID
- NCT06550570
- Acronym / sponsor ID
- PERIDEAMBU / 2024-02Obs-CHRMT
- Conditions
- Childbirth, Epidural; Anesthesia
- Keywords
- Maternal satisfaction, ambulatory epidural, physiology, analgesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 23 Jul 2026 (estimated)
- Study completion
- 23 Aug 2026 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional epidural anesthesia (=before revision of the usual practice of the maternity ward) | – | Behavioral: QEVA questionnaireA local anesthetic and an opioid are administered into the epidural space, as per department protocol (usual practice). |
| Ambulatory epidural anesthesia (=after revision of the usual practice of the maternity ward) | – | Behavioral: QEVA questionnaireLow 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women willing to give birth at CHR Metz/Thionville (maternity)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Hearing or comprehension impairment
- Twin pregnancies
- Scarred uterus
- Fetus in non cephalic position
- Imminent delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QEVA questionnaireQEVA questionnaire administered at 2 days pospartum (in hospital) and 4 weeks postpartum (phone call). (specific for the study) | Behavioural | 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) |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mélanie JUNKE contact
Lisa LEON, MD principal investigator
CHR Metz Thionville Hopital Femme Mère Enfant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childbirth and Epidural; Anesthesia, run by Centre Hospitalier Régional Metz-Thionville at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arpiné EL NAR, PhD (0033387557766, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetrical labor and delivery experience in birthgiving women (time frame: at 2 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.