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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

Tracking Information
First Submitted Date January 23, 2019
First Posted Date January 29, 2019
Last Update Posted Date March 10, 2020
Actual Study Start Date January 23, 2019
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 25, 2019)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observatory of Unintentional Births Hospital Extras
Official Title Observatory of Unintentional Births Hospital Extras in Hérault
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Unexpected delivery outside maternity in the Hérault department
Condition Unexpected Delivery Outside Maternity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 25, 2019)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2022
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Absence of medicalization
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Christelle GRAF, wise woman 0677696194 ext 33 c-graf@chu-montpellier.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03820505
Other Study ID Numbers RECHMPL18_0442
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: NC
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators
  • SDIS34 - MONTPELLIER
  • SAMU CHU Montpellier
Investigators
Principal Investigator: Christelle GRAF, wise woman University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date March 2020