Outpatient BirthACCAMBUNCT03815227
Outpatient Birth: Pilot Study
A study testing Outpatient birth in people with Outpatient Birth, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
The diminution of the average length stay (ALS) in French maternity is a clear evolution, the objective of the draft law on social security is to reduce the ALS to equal other OECD countries. The over-medicalization of maternal health raises the question of relevant and iatrogeny of Professional practices. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Outpatient Birth
- What is being tested?
- Outpatient birth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2019to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- With no multiple pregnancy, of less than 20 weeks of gestation
- With a BMI between 17,5 and 35 kg/m²
- is able to understand research's informations
- affiliated member of the social security system
- Have given an informed consent
Who cannot join
- With psychological vulnerability, social vulnerability, addictions and high dependency
- With an unbalanced chronic pathology or susceptible to contraindicated a physiologic birth
- With history of caesarean, foeto-maternal incompatibility, gestational hypertension, pre-eclampsia, HELLP syndrome or retro-placental hematoma, sphincter tear
- With history of birth with perinatal asphyxia and sequelae or an unexplained perinatal death
- With history of puerperal psychosis
- Under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outpatient Birth: Pilot Study to Assess the Feasibility of Maternity Out the Same Date or the Next Day of the Birth
The diminution of the average length stay (ALS) in French maternity is a clear evolution, the objective of the draft law on social security is to reduce the ALS to equal other OECD countries. The over-medicalization of maternal health raises the question of relevant and iatrogeny of Professional practices. Furthermore, pregnant woman, future parents expressed their wish for an individual support and more physiological respectful. A more-effective Professional coordination is expected where the midwife is a major player.
Read the detailed description
The aim of the study is to identify and evaluate an outpatient birth path during the first 24 hours after the birth.
- Conditions
- Outpatient Birth
- Being tested
- Outpatient birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient birthOther
Maternity out the same date or the next day of the birth and home-based follow up with a liberal midwife
| Study group | Role | What they receive |
|---|---|---|
| Outpatient birth | Experimental | Maternity out the same date or the next day of the birth Receives: Other: Outpatient birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Output rate
Output rate within 24 hours of birth
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start31 Jan 2019
- Primary completion30 Jun 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outpatient BirthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815227
- Sponsor's protocol ID
- 2016-06-CHRMT
- Acronym
- ACCAMBU
- Status last verified
- May 2022
- First submitted
- 23 Jan 2019
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Birth: Pilot Study to Assess the Feasibility of Maternity Out the Same Date or the Next Day of the Birth
- ClinicalTrials.gov ID
- NCT03815227
- Acronym / sponsor ID
- ACCAMBU / 2016-06-CHRMT
- Conditions
- Outpatient Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 24 Jan 2019 (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.
The diminution of the average length stay (ALS) in French maternity is a clear evolution, the objective of the draft law on social security is to reduce the ALS to equal other OECD countries. The over-medicalization of maternal health raises the question of relevant and iatrogeny of Professional practices. Furthermore, pregnant woman, future parents expressed their wish for an individual support and more physiological respectful. A more-effective Professional coordination is expected where the midwife is a major player.
Detailed description
The aim of the study is to identify and evaluate an outpatient birth path during the first 24 hours after the birth.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient birth | Experimental | Other: Outpatient birthMaternity out the same date or the next day of the birth |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- With no multiple pregnancy, of less than 20 weeks of gestation
- With a BMI between 17,5 and 35 kg/m²
- is able to understand research's informations
- affiliated member of the social security system
- Have given an informed consent
Key exclusion criteria (6 listed)
- With psychological vulnerability, social vulnerability, addictions and high dependency
- With an unbalanced chronic pathology or susceptible to contraindicated a physiologic birth
- With history of caesarean, foeto-maternal incompatibility, gestational hypertension, pre-eclampsia, HELLP syndrome or retro-placental hematoma, sphincter tear
- With history of birth with perinatal asphyxia and sequelae or an unexplained perinatal death
- With history of puerperal psychosis
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 |
|---|---|---|
| Outpatient birthMaternity out the same date or the next day of the birth and home-based follow up with a liberal midwife | Other | Outpatient birth |
Primary outcome
Output rate
Time frame: Day 1
Output rate within 24 hours of birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient birth in people with Outpatient Birth, run by Centre Hospitalier Régional Metz-Thionville at 1 site 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 6 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: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Output rate (time frame: Day 1). 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 6 May 2022.