Unexpected Delivery Outside MaternityAIEH34NCT03820505
Observatory of Unintentional Births Hospital Extras
An observational study of Unexpected Delivery Outside Maternity, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In France, pre-hospital unexpected birth is a rare situation, but over the last ten years, the investigators have seen an increase in the number of these. For this, the investigators realize an observatory of these deliveries and their care from the call for help and the investigators continue the follow-up and the… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unexpected Delivery Outside Maternity
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2019to 28 Feb 2022
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Unexpected delivery outside maternity in the Hérault department
Who may be able to join
- Unexpected delivery outside maternity, presence of a medical team during the care
Who cannot join
- Absence of medicalization
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Christelle GRAF, wise woman, 0677696194 ext. 33, c-graf@chu-montpellier.fr
About this study
Official title: Observatory of Unintentional Births Hospital Extras in Hérault
In France, pre-hospital unexpected birth is a rare situation, but over the last ten years, the investigators have seen an increase in the number of these.
For this, the investigators realize an observatory of these deliveries and their care from the call for help and the investigators continue the follow-up and the future of patients and newborns until J7 postpartum.
Read the detailed description
As a result, the investigators also found a very high variability in the number of deliveries per month for the EMS 34 and the SSSM of the SDIS 34, which can reach up to 11 deliveries per month (May 2014 example).
Formalized expert recommendations were published in 2010 by SFAR, which then led to the establishment of a national observatory for IEA at the end of 2011, in which the investigators have been participating for 4 years.
Currently the national database lists 2000 unannounced deliveries including 230 in the Hérault.
This observational study allows us to evaluate the management of these patients and newborns, the risks and needs of pre-hospital teams, including the need for reinforcement and expertise of midwives.
The investigators can also assess mortality and morbidity, as well as the extension of hospital stays beyond J7
- Conditions
- Unexpected Delivery Outside Maternity
- Keywords
- obstetrics, pre-hospital emergencies unannounced delivery outside maternity,, mortality-morbidity, reinforcement midwife in pre-hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
number of unexpected hospital deliveries (AIE)
Estimate the impact of non-maternal AIE by the SMUR and the SSM in the department of Héraul, and compare it to the national overall activity
Measured: DAY 0 TO DAY 7 TO DELIVRERY
Secondary outcomes (4)
Method of taking care of unannounced extra hospital deliveries
Method of taking care of unannounced extra hospital deliveries
Measured: DAY 0 TO DAY 7 POST DELIVRERY
Difficulties during an unexpected delivery outside maternity
Identify the difficulties during an unexpected delivery outside maternity
Measured: DAY 0 TO DAY 7 POST DELIVRERY
Risks during an unexpected delivery outside maternity
Identify the risks during an unexpected delivery outside maternity
Measured: DAY 0 TO DAY 7 POST DELIVRERY
Possible immediate complications during an unexpected delivery outside maternity
Identify the possible immediate complications during an unexpected delivery outside maternity
Measured: DAY 0 TO DAY 7 POST DELIVRERY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start23 Jan 2019
- Primary completion1 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexpected Delivery Outside MaternityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- SDIS34 - MONTPELLIER, SAMU CHU Montpellier
- Responsible party
- Sponsor
- Investigators
- Christelle GRAF, wise woman, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820505
- Sponsor's protocol ID
- RECHMPL18_0442
- Acronym
- AIEH34
- Status last verified
- Mar 2020
- First submitted
- 23 Jan 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of Unintentional Births Hospital Extras in Hérault
- ClinicalTrials.gov ID
- NCT03820505
- Acronym / sponsor ID
- AIEH34 / RECHMPL18_0442
- Conditions
- Unexpected Delivery Outside Maternity
- Keywords
- obstetrics, pre-hospital emergencies unannounced delivery outside maternity,, mortality-morbidity, reinforcement midwife in pre-hospital
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- SDIS34 - MONTPELLIER, SAMU CHU Montpellier
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 29 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.
In France, pre-hospital unexpected birth is a rare situation, but over the last ten years, the investigators have seen an increase in the number of these.
For this, the investigators realize an observatory of these deliveries and their care from the call for help and the investigators continue the follow-up and the future of patients and newborns until J7 postpartum.
Detailed description
As a result, the investigators also found a very high variability in the number of deliveries per month for the EMS 34 and the SSSM of the SDIS 34, which can reach up to 11 deliveries per month (May 2014 example).
Formalized expert recommendations were published in 2010 by SFAR, which then led to the establishment of a national observatory for IEA at the end of 2011, in which the investigators have been participating for 4 years.
Currently the national database lists 2000 unannounced deliveries including 230 in the Hérault.
This observational study allows us to evaluate the management of these patients and newborns, the risks and needs of pre-hospital teams, including the need for reinforcement and expertise of midwives.
The investigators can also assess mortality and morbidity, as well as the extension of hospital stays beyond J7
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Unexpected delivery outside maternity in the Hérault department
Key inclusion criteria (1 listed)
- Unexpected delivery outside maternity, presence of a medical team during the care
Key exclusion criteria (1 listed)
- Absence of medicalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of unexpected hospital deliveries (AIE)
Time frame: DAY 0 TO DAY 7 TO DELIVRERY
Estimate the impact of non-maternal AIE by the SMUR and the SSM in the department of Héraul, and compare it to the national overall activity
4 secondary outcomes
Method of taking care of unannounced extra hospital deliveries
Time frame: DAY 0 TO DAY 7 POST DELIVRERY
Difficulties during an unexpected delivery outside maternity
Time frame: DAY 0 TO DAY 7 POST DELIVRERY
Risks during an unexpected delivery outside maternity
Time frame: DAY 0 TO DAY 7 POST DELIVRERY
Possible immediate complications during an unexpected delivery outside maternity
Time frame: DAY 0 TO DAY 7 POST DELIVRERY
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
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.
Christelle GRAF, wise woman principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unexpected Delivery Outside Maternity, run by University Hospital, Montpellier 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christelle GRAF, wise woman (0677696194 ext. 33, c-graf@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of unexpected hospital deliveries (AIE) (time frame: DAY 0 TO DAY 7 TO DELIVRERY). 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 10 Mar 2020.