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Observatory of Unintentional Births Hospital Extras (AIEH34)

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ClinicalTrials.gov Identifier: NCT03820505
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
SDIS34 - MONTPELLIER
SAMU CHU Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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 future of patients and newborns until J7 postpartum.


Condition or disease
Unexpected Delivery Outside Maternity

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

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observatory of Unintentional Births Hospital Extras in Hérault
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Method of taking care of unannounced extra hospital deliveries [ Time Frame: DAY 0 TO DAY 7 POST DELIVRERY ]
    Method of taking care of unannounced extra hospital deliveries

  2. Difficulties during an unexpected delivery outside maternity [ Time Frame: DAY 0 TO DAY 7 POST DELIVRERY ]
    Identify the difficulties during an unexpected delivery outside maternity

  3. Risks during an unexpected delivery outside maternity [ Time Frame: DAY 0 TO DAY 7 POST DELIVRERY ]
    Identify the risks during an unexpected delivery outside maternity

  4. Possible immediate complications during an unexpected delivery outside maternity [ Time Frame: DAY 0 TO DAY 7 POST DELIVRERY ]
    Identify the possible immediate complications during an unexpected delivery outside maternity



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Unexpected delivery outside maternity in the Hérault department
Criteria

Inclusion Criteria:

  • Unexpected delivery outside maternity, presence of a medical team during the care

Exclusion Criteria:

  • Absence of medicalization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820505


Contacts
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Contact: Christelle GRAF, wise woman 0677696194 ext 33 c-graf@chu-montpellier.fr

Locations
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France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: Christelle GRAF, wise woman    0677696194 ext 33    c-graf@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
SDIS34 - MONTPELLIER
SAMU CHU Montpellier
Investigators
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Principal Investigator: Christelle GRAF, wise woman University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03820505    
Other Study ID Numbers: RECHMPL18_0442
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
obstetrics
pre-hospital emergencies unannounced delivery outside maternity,
mortality-morbidity
reinforcement midwife in pre-hospital